Eastern Europe, Obesity Among Highest in Europe!

The 15th European Congress on Obesity is taking place in Budapest, Hungary this week. In the article European Congress on Obesity deals with bariatric surgery techniques, outcomes and metabolic benefits, I was surprised to read that "[s]pecial attention was needed in Eastern Europe where obesity rates are among the highest and particularly to the alarming increase in childhood obesity."

I don't know about you, but when I think Ukraine or Azerbijan, I don't think obesity.

How is it that Eastern Europe is growing fatter, faster than the rest of Europe?

If countries in Eastern Europe are growing fatter, I have to wonder, do they also have high rates of CHD?

Seven countries in Eastern Europe have abyssimal rates of CHD in men; in fact, per 100,000, deaths from CHD is reported as:

• Armenia 464
• Georgia 507
• Uzbekistan 540
• Moldova 650
• Azerbijan 662
• Kazakhstan 703
• Ukraine 839

In the United States, deaths from heart disease is 106.5/100,000.

Their life expectancy isn't too good either:

• Armenia 71.84
• Georgia 76.09
• Uzbekistan 64.58
• Moldova 65.65
• Azerbijan 63.85
• Kazakhstan 66.89
• Ukraine 69.98

In the United States, our life expectancy is 77.85 years.

I bet they eat too much fat in their diet!

Oh, maybe not....

In each country, the percentage of calories from fat:

• Armenia 17.2%
• Georgia 18.5%
• Uzbekistan 28.7%
• Moldova 16.7%
• Azerbijan 16.4%
• Kazakhstan 28%
• Ukraine 25.1%

Ok, I bet they eat way too much saturated fat in their diet!

Oh, maybe not....

All consume less than 10% of their calories from saturated fat, and three even consume less than the AHA's optimal target of "less than 7%" of calories from saturated fat:

• Armenia 7.3%
• Georgia 5.2%
• Uzbekistan 9.2%
• Moldova 5.8%
• Azerbijan 5.7%
• Kazakhstan 8.1%
• Ukraine 7.6%

Just some food for thought, since, ya know, we're repeatedly reminded to reduce our dietary fat, and especially our consumption of saturated fat; of course this is in an effort to not only keep our weight within normal, but also to reduce our risk for coronary heart disease (CHD).

Data from MONICA and CIA World Factbook.

Weight Loss, Cholesterol and Blood Sugar Improvements - What's the Wonder Drug Now?

While the media is hot and heavy to lead their headlines with junk science complete with amateurish conclusions, a study was quietly published Friday in the journal, Molecular and Cellular Biochemistry - Beneficial effects of ketogenic diet in obese diabetic subjects (abstract) - that's remains ignored.

No fanfare, no ballyhoo, in fact, not one headline to call attention to the significant findings, over the course of a year, of a dietary trial in obese subjects with and without type II diabetes.

Findings that included:

For both groups, diabetic and normal glucose:

• Weight loss of 24.55kg in 56-weeks (that's 54-pounds)
• Total Cholesterol down 19.3%
• LDL down 28.2%
• HDL up 52.3%
• Triglycerides down 59%
• Fasting Blood Glucose down 31%

For those with type II diabetes:

• Weigth loss of 24.4kg in 56-weeks (that's 53.7-pounds)
• Total Cholesterol down 28.5%
• LDL down 33%
• HDL up 63.4%
• Triglycerides down 40.8%
• Fasting Blood Glucose down 50.9% (yes, glucose fell more than 50%)

So, what exactly did the researchers have these subjects do that led to such impressive improvements over the course of 56-weeks?

Sixty-four subjects were divided into two groups - thirty one had abnormal glucose levels (type II diabetes) and the remaining thirty-three had normal glucose levels. Both groups were instructed to modify their diet to include only 20g of carbohydrate a day from a list of foods allowed along with 5-tablespoons of olive oil on salads, and allowed 80g-100g of protein from meat, eggs, fish, poultry and full-fat cheese each day. No alcohol was consumed by participants. At week 12, participants were allowed to increase carbohydrate to 40g per day. Throughout the 56-weeks some foods were forbidden - flour, bread, rice, macaroni, noodles, honey, sugar, sweets, cakes, potatoes, all fruit juices and all soft drinks.

Yes, shocker - the study was designed to measure the effects of a ketogenic diet in subjects with and without type II diabetes.

So, with the above findings, it's no wonder this one is being quietly ignored.

While the media, government policy makers and leading health organizations keep wishing for negative findings from studies of low carbohydrate diets, the opposite keeps happening - the pile of studies finding significant improvement keeps growing higher and higher.

How profound were the changes in real numbers?

Those with diabetes had baseline fasting blood glucose levels of 188.64mg/dl; by the end of the trial, at week 56, their fasting blood glucose averaged 87.66mg/dl. Even those with normal blood glucose, who started with a baseline fasting blood glucose of 92mg/dl, saw improvement; at the end of the trial they had a fasting blood glucose of 85mg/dl.

There is not one drug on the market today, recommended for those with diabetes, that shows such significant improvement in fasting blood sugar, sustained over a period of more than a year!

Oh, but it gets better. Cholesterol improvements in this trial were unmatched by any drug trial.

Those with diabetes:

Baseline Week-56

Total Cholesterol 265 190
LDL 203 131
HDL 39 62
Triglycerides 418 89

Those with normal glucose:

Baseline Week-56

Total Cholesterol 214 181
LDL 156 109
HDL 47 63
Triglycerides 160 77

No cholesterol medication reduces LDL by 33% while also increasing HDL by 63.4%; and reducing triglycerides by 59%.

If the above finding were for a new drug, not only would the headlines be screaming for everyone with dyslipidemia to be prescribed it immediately, but every last expert in the country would be making the rounds in the media to be heard about this new wonder drug!

Sadly this isn't a new wonder drug rich with potential for profits. Instead it's simple dietary therapy, with no bottomline enhancement for anyone, save for a few farmers and ranchers.

So no headlines, no urgent call to take a look at the data which validates previous studies, no demands for reviewing the evidence; nope, the powers that be will continue along, fingers in ears, singing "La La La" as they hope no one notices the mountain of evidence growing.

If you have diabetes, or are at risk for developing diabetes, get to know what a carbohydrate restricted diet is and how to integrate it into your health management, it may save your life.

UPDATE 4/24/2007

A reader brought to my attention a pretty glaring error in reporting of reduction of triglycerides. I posted the numbers from the full-text above as published - a reduction in triglycerides in those with high blood glucose = -40.8%

A review of the actual numbers shows a reduction over the 56-week period from 4.681mmol/l to 1.006mmol/l - a 78.72% reduction in those with high blood glucose; and from 1.827mmol/l to 0.861mmol/l in those with normal blood glucose - a 54.01% reduction.

High Fat Meal Deadly, Take Two

Oh joy, it's deja vu!

• Single high-fat meal may be harmful to health
• Canadian scientists find even single high-fat meal harms body
• Research: A Steady, High-fat Diet Is Bad
• A steady, high-fat diet is bad, but the news gets worse

The study spawning the headlines - A High-Fat Meal Increases Cardiovascular Reactivity to Psychological Stress in Healthy Young Adults - was published in the Journal of Nutrition.

The "high fat meal" in question? A breakfast from McDonald's consisting of an Egg McMuffin, a Sausage McMuffin and 2 hash browns.

Junk science meets junk journalism again - it makes great headlines, but doesn't do a thing to advance our knowledge base, except maybe to point out what makes science "junk."

In this instance, one graphic is all that's needed to dispel the myth that dietary fat - high total fat or high saturated fat - leads to cardiovascular disease. Data from MONICA:

Thirteen Days Remain for Comments

A quick reminder - the FDA is awaiting comments on their proposed guidance document concerning Complementary and Alternative Medicine. It is Docket No. 2006D-0480 and the full-text is here: Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.

I previously urged readers to submit comments here, or send comments via snail mail to:

Dockets Management Branch (HFA-305)
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Be sure when you do to include Docket Number 2006D-0480 in your submission.

Please carefully read the document and pay attention to the terminology used.

The document, if approved, specifically medicalizes complementary and alternative therapies, along with the products, supplements, devices and even foods often part of those therapies. By using "treatment" rather than "therapy;" - "medical" rather than "modality;" the document terminology sets traditional and alternative approaches to well-being and health inside allopathic or conventional medicine in the United States and will regulate products currently protected by congressional legislation, in DSHEA (Dietary Supplement Health and Education Act of 1994).

The document, if approved, effectively renders the DSHEA null-and-void, not by congressional mandate, but by a cunning use of terminology to eliminate the limitations the law imposes on the FDA in its current oversight of dietary supplements.

Please take a few moments to add your comments that an end-run around congress is unacceptable - DSHEA was enacted into law after extensive public debate and only public debate, in the House and Senate - in our legislature - should preceed any change made to its mandates.

If the FDA wants greater authority to regulate supplements they need to go to congress and make their case to amend DSHEA, not make an end-run around the existing legislation!

What's so Special about Protein Anyway?

When we hear the word "diet" we often conjure up thoughts of deprivation, hunger and the frustration of short-term attempts to lose weight. But "diet" also means how we eat on a daily basis - so the diet we eat to lose weight should, ideally, be the diet we eat for the long-term.

I agree with this idea and strongly encourage those trying to lose weight to eat a dietary pattern they'll make habit over the course of their weight loss and beyond as they then maintain their weight.

Where I disagree with this idea is in the idea that our macronutrient (protein, carbohydrate, fat) intake should be set by percentage of our calories, in strict ratios with each other, in an attempt to keep the equation "balanced" - up to 35% of calories from total fat, less than 10% (or less than 7%) of calories from saturated fat, 55-65% of calories from carbohydrate, and the remaining 10-15% of calories from protein.

We're repeatedly told a "balanced diet" remains within these percentages of calories and to maintain them while in a calorie deficit if we're trying to lose weight; going beyond those percentages and consuming too much fat, saturated fat or protein is detrimental to our long-term health.

Yesterday I closed my post with "The first, and most important rule you need to know in the "diet game" is eat your protein; and make it complete protein."

Protein is the macronutrient we take for granted, underestimate the power of, and assume we get enough of each day in our diet.

By undervaluing protein in our diet, by making the assumption that most people eat more than enough, we fail to focus on not only the building blocks of life itself, but the building blocks of our endocrine system - our hormone system.

Without adequate intake of essential amino acids, we rob our metabolism of the building blocks to function normally.

When we diet to lose weight, restrict calories and maintain the ratios suggested to keep our diet "balanced," we willfully starve our metabolism and endocrine system of the critical elements required to maintain function.

This is because our requirement for protein, for essential amino acids, is not based on a simple percentage of calories, but on how much we weigh.

If a woman, who is 5'6" tall, 30-years old and weighs 250-pounds goes to MyPyramid.gov, she'll be presented with a food plan providing 1,800-calories a day to gradually lose weight.

She will find her recommendation includes:
6-ounces of grains (Aim for 3 whole grains)
2.5-cups of vegetables
1.5-cups of fruit
3-cups of milk
5-ounces of meat and beans
Aim for 5-teaspoons of oils a day
Limit extras (extra fats & sugars) to 195-calories a day

The first critical problem with the recommendation is the calorie level - our hypothetical woman above has a Basal Metabolic Rate calculated at 1900-calories a day.

As the Discovery Health BMR Calculator page says "You expend energy no matter what you're doing, even when sleeping. Thus your Basal Metabolic Rate is the number of calories you'd burn if you stayed in bed all day...depriving yourself of food in hopes of losing weight also decreases your BMR, a foil to your intentions."

But let's set that aside for this post and look at what she is presented with as a food plan and determine if it meets her nutrient requirements, as the site contends it will.

First let's pretend she laughs off the idea of eating beans instead of meat - this makes our task of examining her protein intake easier since we'll be able to determine her intake of complete protein without having to adjust for the limiting amino acids in grains or legumes (beans).

With 3-cups of milk and 5-ounces of meat, the total intake of complete protein (if this is followed to the letter) is 56-grams.

Now, some would contend that this is above the 46g DRI (Dietary Reference Intake) established by the Institutes of Medicine for a 30-year old female. Such a contention fails to consider the IOM basis of 46g of complete protein is based on a female who weighs 128-pounds. Our hypothetical woman weighs 250-pounds!

Protein intake - that is complete protein, providing all essential amino acids in the proper ratio - is based on the formula 0.8g/kg body weight. The IOM considers this the absolute minimum required each day. So, our hypothetical woman, who weighs 250-pounds is 113.6kg, thus requires a minimum of 91g of complete protein each day.

But wait, you might say, she has other things she'll eat that provides protein!

That is true. But, with 1800-calories, planned as recommended above, she'll consume about 80-90g of total protein, and depending upon what she actually eats, she is likely to miss adequate intake of all her essential amino acids; even with careful planning and optimal selections of whole foods, she'll also likely fail to meet DRI for Potassium, Vitamin D, Niacin, Magnesium, and Vitamin E; add to this she'll likely fail to meet omega-3 requirements while consuming an excess of omega-6.

But hey, her saturated fat intake is just 6% of her calories, her cholesterol intake would be about 100mg, and her fiber intake in the neighborhood of 35g - according to the recommendations, she's eating a "healthy diet," and reducing her risk of disease by keeping her saturated fat and cholesterol intake below the maximum allowed.

On paper her diet looks just great!

In her body, in her metabolism, it's a nightmare if followed for any length of time.

This is because chronic, habitual nutrient deficiency - whether it is a diet deficient in vitamins, minerals, or trace elements, essential amino acids, essential fatty acids, or a combination of deficiencies - places a burden on the metabolism to function without all of its needs.

Oh, you won't die with a shortfall in nutrients; atleast not immediately...no, your metabolism will continue limping along, as best it can with what you give it to work with.

But really, do you want to do that, or do you want to eat in a way that optimizes your metabolism?

How about we design a menu for our hypothetical women, one for her, that is designed specifically to meet her nutrient requirements rather than conform to a set of percentages.

Based on what we know her Basal Metabolic Rate is (what she needs for basic function before she gets moving each day), she should consume 1,900-2,000 calories and first focus on ensuring she eats 91g of complete protein each day.

If we start there, and include as part of her day 4-ounces of lean roast beef, 16-ounces of plain whole milk yogurt, 3-ounces of tuna in oil, 2 eggs, and 1/4 cup shredded natural cheddar cheese - we've included all her complete protein for the day - 91g - and started her menu with 946-calories. We have 954-1054 more calories to add to her menu.

Now we get to add in her vegetables, fruits and other foods to ensure she consumes adequate intake of the additional nutrients needed; the focus here should be first on vegetables since they're rich with vitamins, minerals and trace elements.

Let's add to her menu a salad for lunch, with 2-cups of romaine, 6 cherry tomatoes, 1/2 a sliced cucumber, 1/2 cup shredded red cabbage, and some crimini mushrooms and we'll let her top it with olive oil and vinegar; then she'll have 1-cup of steamed broccoli at dinner with her roast beef and she can indulge and include 1-tablespoon of butter to make it taste good.

As part of her breakfast, which includes the two eggs above, she'll also include 1-cup of baby spinach (raw amount to be added to egg omelet) and 1/4 cup of shredded cheddar cheese. Her breakfast will also include the one of the two cups of plain yogurt, in which she'll add 1-cup of strawberries.

Her snacks during the day will include 1-ounce of almonds with 1-ounce of sesame seeds; she'll include 1-cup of blueberries with the other 1-cup of plain yogurt, add some water and have a delicious smoothie; and she'll have 1/2 an avocado too, perhaps with her lunch or just a snack during the day.

At this point, her menu provides 1,931-calories.

But wait, she hasn't included any grains! Surely this menu is going to be deficient for essential nutrients if she isn't eating grains!

Not so fast.

The above menu provides all essential nutrients, including fiber, with one notable exception - vitamin D, the most difficult nutrient to obtain from food. She can, of course, go out in the sun for 20-minutes this time of the year each day and make all the vitamin D she needs in her skin. In months where we cannot produce vitamin D in our skin, she can add a vitamin D supplement or make different choices with foods rich with vitamin D or include cod liver oil.

But the above menu, even though it provides all essential nutrients, is a nightmare for those espousing the dietary recommendations - it's high in total fat, saturated fat and exceeds maximum allowance for cholesterol; the carbohydrate is lower than recommended (even though fiber is above recommendations), and it does not include any grains!

Which begs the question - what would you rather eat?

A menu designed to meet your calorie requirements to function before any activity but still a calorie deficit to enable weight loss - designed to provide all essential nutrients including the critical essential amino acids and essential fatty acids - or - a menu that looks pretty on paper but fails your endocrine system because it is nutritionally bankrupt?

Diet - Not a Numbers Game Afterall

When searching online for topics to write about, I often hit google news and conduct a search based on various keyword combinations - diet, health, obesity, weight, diabetes - and I'm never disappointed by the sheer number of results. On Friday I noted that the headlines are often contradictory and those I posted were all within the first five pages of results using just two keywords - diet and health - in a search of the news headlines.

So, what are we to make of dieting to lose weight? Is it a losing proposition? If it is, then why the repeated attempts to encourage the masses to diet? And, most importantly, does dieting really work?

I think it's safe to say that the most widely recommended diet for weight loss - a calorie restricted, low-fat, carbohydrate rich diet - fails the test long-term. While intially reducing weight, in the long-term, such diets do little to improve health and enable a stable, lower weight over time.

The failure of the dietary recommendations are no small matter, various agencies go to great pains to explain away the long-term failure and wind up making the issue one of personal failure rather than admit the flaw is in the recommendations.

Whether or not an individual is able to lose weight and maintain the weight loss becomes a moral issue - having willpower over hunger, taking responsibility for portions, just eat less, just exercise more, stop buying junk food, etc. When the outcome is positive, the diet worked; when the outcome is negative, the person failed to follow directions.

As Malcolm Evans summed up in his commentary, Dieting is Fine Because it is Becoming Official, "The argument goes like this - the state in its wisdom has spoken; overweight is a health issue and as such it becomes a moral issue concerning wellness, interdependencies and budgets. Weight is to be managed downwards and to disobey will result in an implicitly escalating scale of reputational and material penalties (including the denial of certain health care provision). Biomedicine currently prioritises a sense of cure over comfort. The emphasis in almost all cases is to be seen to be powerful in the chemical intervention, with much less emphasis on empathy in relation to the inevitable, or on the emotional and psychosomatic dimensions. It is a culture that allows ten minutes and the prescription of a tranquilliser. It is also a culture which disallows the complexity of overweight and seeks rapid intervention, preferably leading to the mapping of satisfactory digits to numbered targets. In the absence of a magic weight control pill (how Big Pharma would love to have one of those that was in any way remotely effective!), dieting is perpetuated despite the accumulating evidence that it is a largely ineffective alone as a long-term solution."

As I noted on Friday, Fred Hahn said it well, "Fat loss and health is NOT a numbers game - it's a hormonal game. And a game that requires full understanding of the rules."

Yet the government and leading health organizations continue to perpetuate a dietary approach based on numbers - calories, fat grams, saturated fat grams, milligrams of cholesterol, sodium intake, fiber intake, the size of portions, and the number of minutes you engage in exercise each day. It's all about counting one or more things each day in your diet and lifestyle.

All of the recommendations made to the masses come back to one single hypothesis - dietary fat is deadly and must be limited to not only keep calorie intake balanced - fat has nine calories per gram and carbohydrate and protein just four - but to prevent development of chronic disease.

Recently the obession with total fat has relaxed a bit, from strictly maintaining an intake below 30% of calories, to an allowance now of a range between 20% and 35% of calories. But this concession comes with a stricter limit on saturated fat; we're now told to limit saturated fat to less than 7% of our calories, making it next to impossible to meet nutrient requirements for essential amino acids in those who are overweight or obese.

Ah, the unintended consequences of playing, on paper, with macronutrient ratios.

You see, if we take the recommendation to consume less saturated fat to heart, and also strictly limit our cholesterol intake as also recommended, we are left with significantly less animal foods in our diet each day, now dependent on plant-based sources of protein to meet our essential requirements for amino acids.

Surely, you say, there must be strong evidence to support these recommendations? Surely we can easily meet our essential amino acid requirements with a plant-based diet? Surely a diet recommended by the government and leading health organizations must be soundly established by scientific data and be shown to lead to long-term outcomes in health and well-being?

Well, not so fast.

Here is where, as Fred Hahn called it, the "hormone game" comes into play and the rules are such that if you're not playing within them, your health suffers.

The first, and most important rule you need to know in the "diet game" is eat your protein; and make it complete protein.

Tomorrow I'll explain why and then discuss the other rules of the "hormone game" to give you insight into why everything we're told about diet is either wrong and causing more harm than good in your metabolism!

Then, throughout the week, we'll sort out what to eat if you're trying to lose weight and improve your health for the long-term.

The MIsadventures of Dieting in America

If you're like most Americans, you're bombarded each day with headlines that completely contradict other headlines:

• Health warning: all diets make you fat
• Diets do work... and here's how

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• Reducing Weight Without Dieting
• Lose weight or lose control

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• Good' Foods Make you Gain Weight Too
• Lose weight by eating more

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• Loosing fat without trying
• Leftovers can help you eat a third less!

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• Obesity is not just gluttony - it may be in your genes
• Get the 'skillpower' to lose weight

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• Low fat foods trick you into eating more
• Heart Association Explains The Trouble With Fats

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• Slow down at mealtime to lose weight
• Lose Weight During Dinner: Turn Off TV
• So can you REALLY lose weight just by brushing your teeth?
• Lose weight with push from a stranger
• Thinking thin can help you be thin

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• Calculating caloric intake — do the math
• It's official: diets make you fatter

Is it any wonder we're confused about how to lose weight?

I sometimes wonder if the mass confusion, conflicting headlines, contrary opinions and such is by design. No, really, I'm not a conspiracy theorist...but, keep in mind, it is highly profitable to keep people fat, and sick, and coming back for more help isn't it?

So, how do we cut through the confusion and contradictions and simply eat right?

As Fred Hahn said it in a recent reply to comments on his blog regarding calories in, calories out - "Fat loss and health is NOT a numbers game - it's a hormonal game. And a game that requires full understanding of the rules."

Monday we'll begin to lay out those rules!

BE HEARD: FDA Commentary Open for Complimentary & Alternative Medicine

A Guidance Document open for public comments over at the FDA came to my attention this morning. The comment period ends April 30, 2007 and I strongly encourage my readers to take a few moments today to submit comments along with some additional follow-up.

Why?

Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration, Docket No. 2006D-0480 is as detailed and vague as it gets. It seeks to "tie up loose ends" many feel exist in current regulation around approaches used in Complementary and Alternative Medicine (CAM) by establishing guidance for industry about communicating benefits of a "wide array of healthcare practices, products and therapies that are distinct from practices, products, and therapies used in 'conventional' or 'allopathic' medicine."

The critical issues to think about:

1. The guidance document, if finalized as written, will regulate virtually all herbs and supplements as drugs if they actually benefit a medical condition unless it is "generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling."

Not only that, but also...

2. The document, if finalized as written, is extremely vague as to the extent of regulatory reach. For example, the document states, as an example, that vegetable juice (yes, vegetable juice) "absent any claims that would make the juice subject to the drug definition, the juice would be a 'food' under section 201 (f) of the Act because it is used for food or drink for man."

Now earlier in the document, in an attempt to define how vegetable juice might be defined as a drug, it is stated, "This means, for example, if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health, that product is a food subject to the requirements for food in the Act and FDA regulations...If the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would be subject to regulation as a drug under the Act."

The FDA defines a drug as "...(B) articles intended for the use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals..."

So, with that, any person (or product) that states "drink some vegetable juice to prevent [insert disease]" is making a drug claim; and if vegetable juice is not recognized by the FDA as a legally available drug in the United States, the person (or company) making the claim is now subject to prosecution if they are not a medical professional licensed to practice medicine.

Vegetable juice, a drug?

Not only that, but also...

While it may seem unthinkable, consider this, as another blog highlighted, "[i]ts very specificity makes manifest fundamental inconsistencies and absurdities in the DSHEA law. If you substitute "water" for "cranberry tablets" and "severe dehydration" for "urinary tract infection," as found on Page 12, then you've turned water into a drug according to these guidelines. Obviously, the FDA would never turn water into a drug, but the guidelines allow them the option to do so. That "flexibility" alone makes the guidelines dangerous. In reality, what the guidelines do is extend the FDAs authority to arbitrarily decide when to enforce their will."

Not only that, but also...

The most alarming thing to me is the use of language throughout the document - the FDA sets the stage that anyone who is not a licensed healthcare professional (physician, nurse, DO, etc.) will be subject to prosecution for practicing medicine without a license because the terms used, "medicine" rather than modality, "treatment" rather than therapy. This is because of already established regulations and laws in all 50 states as to whom may "treat" medical conditions; these new regulations will specifically limit whom is able to communicate options to consumers to those holding a professional license. Any practitioner - homeopathic, naturopathic, reflexologist, Chinese or Ayruvedc practitioners, nutritionists, etc. - will all be at risk for practicing medicine without a license if they even suggest something like vegetable juice may prevent, treat or mitigate the symptoms of a disease.

Which brings us back to the vague nature of the document...the specific language - everything termed as medicine and treatment - leaves the very real potential that any and all substances - vitamins, minerals, herbs, co-factors, probiotics, etc - could be classed drugs, new drugs, or medical devices if they are being recommended to prevent, treat, mitigate or cure disease states (remember water cures dehydration).

While the media is silent on this, the FDA quietly awaits comments that few know are open.

Well, now you know and now you can let the FDA know what you think - because if we do not comment we'll have no one to blame when we lose access to the vast options available to us right now.

Here is what you can do to let your voice be heard:

1. Submit comments online. Be sure you include the Docket No 2006D-0480 with your comments.

2. You can also send comments via snail mail to:

Dockets Management Branch (HFA-305)
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

3. You can call and chat up the following people and let them know what you think:

Sheryl Lard-Whiteford at 301-827-0379
Daniel Nguyen at 301-827-8971
Ted Stevens at 301-594-1184
Wayne Amchin at 301-827-6739

4. In addition to the above comment submissions, write or call your representatives and senators! You can find the contact information for your representatives in the House and Senate here.

There is Something Perverse About the Atkins Diet...

I've been crazy busy the last few weeks, but absolutely had to stop what I was doing to write about an article today - The Atkins Paradox: What Diet Studies Don't Reveal - by Christopher Wanjek, the "Bad Medicine" columnist over at LiveScience.com.

My headline above was taken directly from the column, "So why not go with Atkins if you can loose weight and eat bacon? The reason, most doctors say, is because there is something perverse about the Atkins diet."

I haven't laughed so hard in, well, a few days. And, what followed was even funnier...Consider the breakfast of a gentleman on the Atkins diet whom I encounter each morning on a commuter train eating an entire block of baloney right out of the package with one hand and washing it down with a diet Coke in his other hand. Between the salt, fat and artificial additives in the lunchmeat and soda, this simply can't be healthy.

Good golly Miss Molly!

I don't know about you, but when I read these stories about someone "on the Atkins diet" - or any carbohydrate restricted approach - doing it completely wrong, well all I can do is laugh. I'm not laughing because the poor fellow eating the bologna and diet coke breakfast is going about Atkins wrong, but because this columnist really, truly believes this guy is a good example to show how "perverse" the Atkins diet is.

For anyone who has not read Dr. Atkins' New Diet Revolution, he was pretty clear to avoid, or at least limit, processed meats - "Processed meats such as ham, bacon, pepperoni, salami, hot dogs, and other luncheon meats - and some fish - may be cured with added sugars and will contribute carbs. Try to avoid meat and fish products cured with nitrates, which are known carcinogens." (page 124, paperback, 1992, 1999, 2002 edition)

In fact, he specifically recommended "Always aim for unprocessed natural foods and select the freshest produce you can find. If possible, purchase organic meats and dairy products." (page 130, paperback, 1992, 1999, 2002 edition)

Not exactly a ringing endorsement of bologna for breakfast each day, huh? Then again, let's not let inconvenient facts get in the way of an article promoting low-fat diets are supreme!

And this presentation of bologna & diet coke for breakfast for an Atkins dieter really isn't the biggest problem with this article.

No, the biggest problem really is the deceptive assessment of the study published in JAMA that I previously wrote about. This is how Mr. Wanjek portrayed the results:

The Atkins and Ornish data have overlapping confidence intervals. This is a measure of statistical strength given sample size and other factors. The study implies that, with 95-percent confidence, the true weight loss could be as low as 6.8 pounds for the Atkins group and as high as 8.2 pounds for the Ornish group.

In fact, the Ornish dieters were closing the gap at 12 months as the Atkins dieters were gaining weight. This supports earlier studies suggesting that a low-fat lifestyle is better at keeping off weight in the long run.

Closing the gap? Who is he kidding? Here is the graph of each group at each measurement interval:





















Note that I've highlighted the Ornish group. I've done that because the contention that they "were closing the gap" and losing weight at 12-months is utter and complete hogwash. As a group, they were gaining weight since the two-month point in the study!

Then the suggestion that the overlapping confidence interval was masking some secret weight loss potential for the Ornish group - more utter and complete hogwash.

What Wanjek didn't say is important and it's that the range of weight loss in those following Ornish and Atkins. Here is the data:

Atkins 4.7kg [95% CI, -6.3 to -3.1kg]

Ornish 2.2kg [95% CI, -3.6 to -0.8kg]

Oh, there was an over-lap all right, but no matter how you slice it, those trying to follow the Atkins diet lost as little as 6.8-pounds (3.1kg) and as much as 13.9-pounds (6.3kg), with an average weight loss of 10.3-pounds for the group. Compare that to those trying to follow the Ornish diet - weight loss was a little as1.8-pounds (0.8kg) and as much as 7.9-pounds (3.6kg) with an average weight loss of 4.8-pounds for the group.

Put another way - the least weight loss in the Atkins group was about the best in the Ornish group. Have a look for yourself:

We're supposed to be convinced that those following Ornish were doing as well as those following (or trying to) Atkins? Oh yeah, that graphic above shows just how close the two dietary approaches were...not.

Pass the nitrite-free bacon and double cream brie, thank you very much.

Carbohydrate Restriction Seminar - Nashville, TN - May 5

It's a bit of short notice, but anyone interested in learning more about the science and research supporting carbohydrate restriction - register to attend the Nutrition & Metabolism Society Seminar at the 2007 Eastern Regional Obesity Course of the American Society of Bariatric Physicians in Nashville, TN, May 5, 2007.

Saturday, May 5
8-8:45 am Low GI and Very Low Carbohydrate Diets for Type 2 Diabetes
Eric C. Westman, MD, MHS

8-8:45 am Low GI and Very Low Carbohydrate Diets for Type 2 Diabetes
Eric C. Westman, MD, MHS

8:45-9:30 am Carbohydrate Restriction for Type 2 Diabetesin Clinical Practice
Mary C. Vernon, MD, FAAFP, CMD

9:30-9:45 am Break

9:45-10:30 am Using the Traditional Diet for Type 2 Diabetes in a Canadian First Nations Community
James A. Wortman, MD

10:30-11:15 am A Review of the American Diabetes Association Recommendations for Dietary Carbohydrate
Judy Wylie-Rosett, EdD

11:15am-Noon Panel Discussion of Morning Speakers

Noon-1:30 pm Lunch & NMS Award Presentation (lunch provided for Obesity Course & NMS attendees)

10:30-11:15 am A Review of the American Diabetes Association Recommendations for Dietary Carbohydrate
Judy Wylie-Rosett, EdD

10:30-11:15 am A Review of the American Diabetes Association Recommendations for Dietary Carbohydrate
Judy Wylie-Rosett, EdD

NMS ATTENDEES ONLY
1:30-2:15 pm Very Low Carbohydrate Diets and Serum Biomarkers of Cardiac Risk
Jeff S. Volek, RD, PhD

2:15-3 pm The Paradox of Fats in the Low Carb Diet
Steven D. Phinney, MD, PhD

3-3:15 pm Break

3:15-3:45 pm Biochemical Aspects of Carbohydrate Restriction
Richard D. Feinman, PhD

3:45-4:30 pm Panel Discussion of Afternoon Speakers

REGISTER HERE

Accreditation
The American Society of Bariatric Physicians (ASBP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The ASBP designates the NMS Seminar for a maximum of 6.5 credit hours in category 1 credit towards the AMA Physicians Recognition Award. Each physician should claim only those hours of credit that he/she actually spent in the educational activity. The program is eligible for AOA-CME credits under category 2-A.

Atkins Editorial Rejected

Five heathcare professionals - Dr. Stephen D. Phinney, MD; Dr. Mary C. Vernon, MD; Dr. Eric C. Westman, MD; Dr. Jay Wortman, MD; and Jacqueline A. Eberstein, RN - recently penned and submitted an editorial response to the recent media attention concerning the A to Z study published in JAMA. It was rejected by JAMA, Newsweek, Time and others. Here it is, in its entirety:

More Science and Less Zealotry, Please.

The controversy over which diet is best for all has again made headlines with the publication of the Stanford University study in the Journal of the America Medical Association March 7, 2007. Since the results are favorable to the low-carbohydrate Atkins diet, the usual criticism can be expected to follow.

Predictably, Dean Ornish has launched a tirade in which he manipulates the study findings to find fault with the low-carb approach and to deflect criticism away from his ultra low-fat diet which did not perform well in the study. Unfortunately, this is an argument based on dogma and not on science. The science speaks for itself.

As scientists and clinicians, we believe that no one dietary approach is going to be ideal for everyone. There is no doubt that, for some, an ultra-low-fat approach may be appropriate. Unlike Dr. Ornish, we recognize that there is no one-size-fits-all approach to the enormously complex problem of obesity and related conditions. Unfortunately, other authoritative sources like the US dietary guidelines also recommend a single lowered fat high-carbohydrate diet approach and have been doing so over the decades that this epidemic has grown.

Gratuitous attacks on the Atkins diet that imply it involves abandonment of wholesome vegetables and fruit for “bacon and brie” are simply wrong. Even in the most restrictive phase it meets the recommended daily guidelines for vegetables and fruits. As one advances through the phases, low-glycemic fruits, more vegetables, legumes and even whole grains are introduced based on an individual’s metabolic tolerance for these foods. One survey found that people who follow the Atkins plan over the long term eat more vegetables than they did before. Another study found that rather than increase the intake of fat and protein to compensate when carbohydrates were reduced, people simply ate less.

The unfortunate reality of today is that too many Americans are eating potato chips and fries and drinking sugar-sweetened beverages. We support the idea that wholesome foods such as meat, fish, cheese and eggs along with vegetables and low glycemic fruits constitute a healthier diet than chips and fries and sodas.

While this study examined four popular dietary approaches, what is clear is that whatever approach one takes to healthy eating, success will depend on how well you can stick to it. In this case, and in many earlier studies, it is clear that the Atkins diet is the one most people can maintain. On the other hand, the extremely low-fat diet advocated by Dr. Ornish is very difficult to follow. In this study, the subjects who were supposed to reduce their fat intake to his recommended intake of 10% could not reach that target.

Another important aspect of this and earlier studies is the beneficial effect that reducing carbohydrates has on metabolic markers. In his criticism, Dr. Ornish states that the LDL-cholesterol level fell in response to his diet, but does not mention that none of the differences in LDL-C in this study were statistically significant. This is therefore not a scientifically valid criticism. On the other hand, it is widely recognized that elevating the HDL-C, the good cholesterol, is an important factor in reducing cardiovascular risk. In this study there was a highly significant 10% rise in HDL-C in the Atkins group but no such change among those who followed the very high-carbohydrate Ornish diet.

In the same vein, the Atkins group demonstrated a significant (both statistically and clinically) greater reduction in systolic and diastolic blood pressure than the other three diets. A difference in mean arterial pressure of 5 mm Hg is about the response we would expect to see with a first-line pharmaceutical in the clinical setting. Any objective observer would acknowledge this as a major beneficial effect of the Atkins diet.

Dr. Ornish suggests that the positive findings of research such as this that supports the Atkins diet will cause problems, and that “many people may go on a diet that harms them based on inaccurate information.” This is a wildly irresponsible statement, given the consistency with which a reduction in important metabolic and cardiovascular risks are achieved by lowering carbohydrate consumption. It is simply preposterous to suggest that an approach that leads to significant risk factor reduction is unhealthy.

The seriousness of the accelerating epidemic compels us to think outside the box to find new solutions where the status quo has failed. The only approach that will be successful is one that people can actually follow. This study adds to the mounting evidence that the Atkins diet is a healthy choice which should be supported as a viable way to lose weight and improve metabolic and cardiovascular risk factors.

The Real Atkins Lifestyle

Before there was research on the Atkins diet it was commonly criticized in the belief that it would elevate cholesterol, ruin one’s kidneys and bones and cause heart disease. None of this has been borne out by the research.

What is clear from this JAMA study, and others like it, is that cardiovascular risk factors actually improve when controlling carbs. The scientific studies of this approach have shown numerous times that a pattern of rising HDL-C and falling triglycerides is the hallmark of carb restriction and that this benefit occurs even in the absence of weight loss.

Research also shows that rising HDL-C (good cholesterol) and falling triglycerides is correlated with larger LDL-C particles which are less likely to cause heart disease. Even the much touted statin drugs do not deliver this kind of improvement in LDL-C particle size. On the other hand, the research shows that eating a high-carb diet and cutting fat intake results in small dense LDL-C particles that are linked to an increased risk of heart disease.

Importance of Fat

There are other problems associated with extremely low fat diets, as well. Cutting fat intake can lead to deficiencies in fat soluble vitamins, depletion of essential fats such as EPA and DHA, and decreases in the absorption of nutrients. Studies also show that people with cholesterol levels that are too low become prone to depression, suicide and cancer and have higher overall death rates than those who have higher cholesterol levels.

When all is said and done, it behooves us to remember that the diet debate is not a horse race where there is only one winner. We know there is a great variability in metabolic and genetic factors that will determine what dietary approach is best for each individual person. Although, in this and many other studies the Atkins diet worked better for more people, it is also evident that other dietary approaches will work for some people as well. The most important thing we have learned from dietary research is that people need to find the approach that will deliver healthy outcomes for them individually. And, just as the proof of the pudding is in the eating, the proof of a diet's effectiveness is whether it can sustain those benefits over the long haul. Hopefully, the weight of the evidence will now allow the Atkins diet to be recognized and supported as a legitimate option for people who want to improve their health through better nutrition.

On a final note, Dr. Ornish’s repugnant attempt to undermine Dr. Atkins’ credibility by perpetuating the myth that he had heart disease is unconscionable. It is unbecoming of any honorable person to make ad hominem attacks on those who are departed. Enough is enough. Dr. Atkins died of a head injury. He is no longer with us, but the line of scientific inquiry that he started continues to vindicate his dietary approach. And no amount of unfounded criticism will alter the fact that this study, and the 60 others before it, clearly demonstrate that what Dr. Atkins had been telling us all along was right.

• Jacqueline A. Eberstein, R.N. Co-author, Atkins Diabetes Revolution, President, Controlled Carbohydrate Nutrition
• Stephen D. Phinney, M.D. Ph.D Emeritus Professor, Department of Medicine, UC Davis, Elk Grove, Cal
• Mary C. Vernon, M.D., CMD, Co-author, Atkins Diabetes Revolution, President, American Society of Bariatric Physicians
• Eric C. Westman, M.D. M.H.S, Associate Professor of Medicine, Duke University Medical Center
• Jay Wortman, M.D, Department of Health Care & Epidemiology, Faculty of Medicine, University of British Columbia

On Vacation

Omega-3 & the Brain

Last month I highlighted research out of Sweden that found four year olds already overweight, with features of metabolic syndrome and deficient in essential nutrients such as iron, vitamin D and omega-3 fatty acids. Interestingly, those children with the highest BMI consumed higher intake of sucrose (sugar) and lower fat.

Today the BBC reports on a very small study - involving four children - who were given fish oil supplements. Tests done at the end of the three-month study found the children showed an increase in reading age of well over a year, their handwriting became neater and more accurate and they paid more attention in class. Brain scans which identified a chemical called N-Acetylaspartate (NAA) which is linked to the growth of nerve fibres in the brain also showed dramatic changes.

Researcher Basant Puri said of his findings, "In three months you might expect to see a small NAA increase. But we saw as much growth as you would normally see in three years. It was as if these were the brains of children three years older. It means you have more connections and greater density of nerve cells, in the same way a tree grows more branches."

A large placebo controlled study is expected to get underway in the coming months to confirm the findings. On this, Puri said "My view is we can't come to any clear conclusion until a proper trial is done."

What is Normal Blood Sugars?

Jenny, over at Diabetes Update, has a great summary of the presentation, What is Normal Glucose? – Continuous Glucose Monitoring Data from Healthy Subjects, presented by Professor J.S. Christiansen, at the Annual Meeting of the EASD last September.

You can read her analysis of the presentation at Diabetes Update: Research Gives More Insight into "What is a Normal Blood Sugar"

Might the Brain Not Know the Body is Fat?

A new study published in Cell Metabolism - Diet-Induced Obesity Causes Severe but Reversible Leptin Resistance in Arcuate Melanocortin Neurons - found that in an obese state, the brain becomes "unaware" the body is fat. These findings, in an animal model using obese mice, showed that a sensor in the brain, that normally detects a critical fat hormone, fails to engage to keeps energy balance in check. Without that signal, various metabolic pathways fail to blunt appetite and keep calorie consumption under control.

As Scientific American opened their article about the research, "Could fat be in the brain of the beholder? A new study shows that signals in the brain that warn appetite-modulating neurons of excess fat stores can be suppressed, making the brain unaware of the body's condition. The result: the body becomes completely ignorant about its own makeup and thus makes no attempt to increase energy expenditure or reduce appetite to help shave flab."

The biological sensors in question? A suppressor called SOCS-3, is believed responsible for contributing to a loss of sensitivity to the hormone leptin. The researchers found "leptin binds to a receptor in the arcuate nucleus, triggering a cascade of chemical signals that culminate in the activation of SOCS-3, a suppressor that stops the reaction. The scientists determined that obese animals had an adequate quantity of leptin receptors, but that the quantity of SOCS-3 had risen, likely thwarting any activation of the fat hormone."

Why this may be critically important in our understanding of obesity is that those who are obese often have higher circulating levels of leptin, suggesting something else is limiting it's action. In this animal model it was found that mice consuming identical calorie intakes did not all maintain similar weight - some became obese. After tweaking the macronutrients (in this instance reducing fat since the mice used in this study are bred to grow obese on a high-fat diet) while maintaining the calorie intake, the mice lost weight back to normal - and, the brain control centers regained sensitivity to leptin.

The researchers caution that the study does not necessarily extrapolate well to humans - additional studies are needed since mice overall have a different physiology than humans. But, the study does have value in the scheme of human metabolism and I hope researchers will continue to look at these metabolic pathways and hormones involved in energy regulation in humans.

Calling for Low-Carb/Controlled-Carb Success Stories

Dana Carpender is one of the folks within the controlled-carb community whom I adore - she's "good people" with an insanely fun personality - she tells it like it is and isn't shy about doing so. She's defnitely a go-getter and not afraid to speak her mind or tackle the hard questions.

Like many of us who've continued along over the years as low-carb waxed and waned in the media, but never stopped gaining in the supporting evidence department, she's convinced it's time to set the story straight about carbohydrate restriction - how to do it properly to lose weight, and more importantly, how to maintain weight loss over the years.

She as my vote of confidence - I followed a low-carb diet to lose 80-pounds back in 2001 and have since maintained that weight loss with a basic carbohydrate controlled approach. My husband, Gil, used a low-carb diet to shed over 100-pounds since 2002 and has since maintained that weight loss with the same basic carbohydrate controlled approach. Dana herself has utilized a carbohydrate restricted diet as her eating style since 1995! Twelve years and counting.

I have no doubt there are millions of us out there, across the US and around the world who've lost weight and maintained our loss without much fuss.

The big question - how do we do it?

Everyone says it's impossible to follow a low-carb (carbohydrate restricted) diet for the long-term; that it's boring; that it eventually will lead to declines in health over the long term. Those of us doing it - day to day, year after year - we know it works and we keep at it because it works.

Now it's time to share with others the how and why of long-term success with carbohydrate restriction!

Dana is asking for our help - she'd like to interview everyone she possibly can in the coming months about the how they do it and why they continue with carbohydrate restriction.

She's posed several questions to start a dialogue, initially via email with those interested in participating in this project:

To what do you attribute your success? Was it support from friends? Family? Online support?

Have you learned to cook a wide variety of low carbohydrate meals?

Planning ahead?

Feeling a lot better?

What do you consider to be the two or three most crucial components in your low carb success?

What were your biggest stumbling blocks? Lack of support, or downright sabotage? Naysaying from your doctor? Boredom with the food? Emotional carb cravings? Discouragement with a plateau? Budget and time constraints? Impulsive eating when junk appears in front of you?

Dana would like to get the project off the ground as soon as possible and is asking for your email replies at voiceofthepeople@holdthetoast.com.

Take a few moments to drop her an email if you'd like to share your success!

She's putting together a proposal and would like to have emails to her by Monday - so what are you waiting for? Email her now!

Quotable Quotes

Who knew?

The results show the Atkins diet is a reasonable choice for short-term weight loss, said Gardner, a vegetarian.

Helps explain....

But the study's lead author warns that the research does not mean dieters should go on the Atkins diet."No, no, no," said Dr. Christopher Gardner, an assistant professor of medicine at the Stanford Prevention Research Center. "This is not a vindication of the Atkins diet."

Can you see him pulling out his hair?

"You lose weight if you have cholera too,'' said Dr. David Katz, director and co-founder of the Yale Prevention Research Center and a longtime critic of the Atkins diet. "You can't measure overall health by a few cardiac risk factors.''

"It's flawed,'' Katz said."Nothing in this study will change nutritional recommendations I make to my patients,'' Katz said.

Katz argues the debate over best types of nutrition should be over. People need fresh fruits and vegetables and should stay away from saturated fats and junk food, he said.

And your evidence is?

"Once the weight-loss stops, the effect of saturated fat would be negative," said James O. Hill, director of the Center for Human Nutrition at the University of Colorado at Denver.

Say it isn't so....

"This study confirms the importance of reducing carbohydrates in the diet," said Dr. Frank Hu, associate professor of nutrition and epidemiology at the Harvard School of Public Health, who was not involved in the research.

"There has been too much emphasis on saturated fat," he said. "Bagels, white bread, potatoes and soft drinks are the real bad guys in our diet."

Did Ornish really just admit Atkins' is easier....?

"It's a lot easier to follow a diet that tells you to eat bacon and brie than to eat predominantly fruits and vegetables," said Dr. Dean Ornish, creator of the Ornish diet.

Keep repeating after me....

Though the study shows Atkins is a safe and effective approach to weight loss, Rex Healthcare registered dietician Natalie Newell still has concerns."You're eliminating a majority of the grain products, fruits and even some vegetables," she said. "So, the major concern I looked at was 'What are you eliminating from your diet?' Vitamins and minerals that come from fruits and vegetables are very important."

I have a hammer....

Dr. Alice Lichtenstein, a nutrition expert at Tufts University, said she thinks too much is made of the amounts of carbohydrates and fats in people's diets as they try to shed weight. “There is no magic combination of fat versus carbs versus protein,” she said. “It doesn't matter in the long run. The bottom line is calories, calories, calories.”

What part of the improvement to risk factors did you miss?

"If they go on an Atkins style diet, there is not going to be negative consequences to their health," says Sheah Rarback, Nutritionist.

Ya Don't Say....

"I think the one thing that really stands out about that Atkins diet was how simple it was," said Dr. Gardner. "Just drastically limit your carbohydrates, with the emphasis being on refined carbohydrates - white bread, white sugar, soda pop, the high fructose corn syrup."

Wonder if anyone else said this...

Dr. Yoni Freedhoff of the Bariatric Medical Institute said [...] “The currency of weight at the end of the day isn’t carbohydrates or proteins or fats, the currency of weight is calories,” he said. “This study proves that too. You can lose weight on any of these approaches. They all have vastly different distributions of carbs, proteins and fats.”

“What matters are the calories in your food.”

Allow me to speculate...

"It shows that people will steadily go back to their old habits," said Dr. Lawrence J. Cheskin, director of the Johns Hopkins Weight Management Center. "After two years, you might find that everybody has regained everything."

Let me try this one again...

"Health is not measured as the combination of several cardiac risk markers and weight over the course of a year," says Dr. David Katz, director of the Prevention Research Center at Yale University School of Medicine. "If it were, every patient getting chemotherapy would be 'healthy.'"

Did anyone else say this?

"Some heart indicators were better, but what about the mountains of evidence about high consumption of fruits and vegetables to promote overall health?" says Keith-Thomas Ayoob, associate professor at the Albert Einstein College of Medicine's department of pediatrics in Bronx, N.Y.

Stupid Public...

"The public may not realize that keeping weight off for one year is no indication of permanence," says Carla Wolper of the Obesity Research Center at St. Luke's Hospital in New York City.

Let me throw this out and see if it sticks....

"Numbers don't lie, but they don't tell the whole story — by a mile," says Jackie Newgent, instructor at the Institute of Culinary Education in New York City. "There are more than just a couple numbers that determine your overall health. And as cholesterol numbers and blood pressure levels improve, it doesn't mean other heart-health indicators improve."

Oh, did I forget to add...

"A healthy diet is the same as it ever was," Katz says. "Focus on health, and the long term, and your weight will take care of itself."

Hmmm, the hammer, OK, I'll swing...

"It's not about demonizing whole food groups," Ayoob says. "It's about how much and how often, and learning to strike a balance between what we know we need, and what we don't want to live without."

Ouch, that's gotta hurt....

"I'm tired of these diet wars," Ornish says. "It's not low-fat versus low-carb. It's both."

Wait, let me re-phrase that....

Previous studies have shown the Ornish diet and lifestyle program could also reverse progression of prostate cancer and diabetes while the Atkins diet has been proved to worsen heart disease, Ornish said. [...] All nutritionists have or should have concerns over the Atkins diet. High fat diet is in no way a healthy diet.

And I'll add...

That dismays Dr. Dean Ornish, [...] "I'm concerned that this study may cause people to forgo eating a healthy diet for one that's actually harmful for them," he said.

Bored yet?

The key word is "boring," said Kathryn Sucher, a nutrition and food science professor at San Jose State University. That, she said, is the reason so many people drop off the Atkins diet and other highly restrictive eating plans.

Oh really?

[Gary] Foster [...] cautioned, "The lipid story is gradually emerging, but it's still unresolved."

I'm so confused....

"It's news that contradicts current healthy-eating advice — a diet heavy on meat and cheese and void of whole grains and fruit can help you lose weight and may even help reduce heart-disease risk, according a study released this week," Leslie Beck "The surprising findings suggest that dieters who lost faith in the low-carbohydrate regime out of concern for their health, might want to reconsider the weight-loss plan."

Finers in my ears....la la la la la la

"This is the message of this article -- focus on lifestyle and environmental factors and don't worry about the macronutrient composition of the diet, particularly if you can achieve the NHLBI guidelines of a 5 to 10 percent weight loss," says Dr. George Blackburn, chair in nutrition medicine at Harvard Medical School. "I think that was my message for the past 20 years."

Tell us what you really think....

Canada.com - One day they're in, the next day they're out again. But whether we're talking about Atkins or South Beach, low-carb diets are one kind of fad that never seems to die.

[and....GASP!....] If you haven't tried a low-carb diet, you may not know that many of these programs restrict all kinds of carbohydrates, and not just the obvious ones, such as bread, rice, and pasta. For example, Atkins, perhaps the best-known low-carb diet around, also excludes most grains, beans, fruits, potatoes, and starchy vegetables, while allowing lots of beef, pork, chicken, eggs, and butter.

A diet that's rich in meat and high in fat can take a toll on your health. [emphasis theirs]

Are you paying attention yet?

Dr. Gardner, [...] still thinks his study is "neat."

"The low-fat message that we had for a long time backfired on us. It was overly simplistic. People went out and bought low-fat cookies and ate the whole box. Maybe this is another piece of evidence that a general, low-carbohydrate message has more merit than people might have given it before."

Just don't do it as recommended....

Gardner said Atkins might work because of its simplicity. Carbohydrates typically account for the biggest proportion of the North American diet. The Atkins diet is also high in protein, which makes people feel fuller longer."Just to say (eat) low carbohydrates doesn't mean anything under the sun goes, including butter and pork rinds and steak and whip cream," Gardner said.

Get it? Got it? Good!

"We've all been worried that the high saturated fat content of Atkins would be bad for you," said study author Christopher Gardner, an assistant professor of medicine at Stanford. The plan's high-fat levels "still make us nervous," he said, "but I think the weight loss that comes with the diet must be more powerful" in keeping cholesterol and other heart risk factors at bay.

File this under I just won't believe it...

''But all diets work. It doesn't really matter which program you're using. When you reduce your calories and get more exercise, you lose weight,'' Burke said. ''Atkins might have had the best results, but I'd like to see what would happen a year from now, or two years from now.''

But of course...

"Yes, on the Atkins diet, the women may have lost a little bit more weight, but I'm not so sure about their quality of life - that's the kind of information that just isn't in here," said dietitian Bonnie Taub-Dix, a New York City weight-control specialist and spokeswoman for the American Dietetic Association.

Keep repeating the message again and again....

Because blood glucose reacts particularly strongly to excessive carbohydrate intake, lowering carbs "might assist blood sugar control," said Harvard endocrinologist Dr Barbara Kahn. "But the [potentially] harmful part has to do whether all those fats over the years are going to lead to more cardiovascular disease. That's the next thing that needs to be studied."

----

So have you read any other notable quotes? If you have one, share it in the comments!

Bad Science - Good Publicity

That is how Dr. Barry Sears characterized the study published in JAMA yesterday in the Atlanta Journal Constitution article, Atkins Diet Vindicated? Well Maybe.

In the research paper detailing the A to Z Weight Loss Study, his dietary approach (Zone) went head-to-head against Atkins, LEARN and Ornish and had the least influence on weight.

In the AP article, found on MSN, he said the "study had a good concept and incredibly pathetic execution."

Sour grapes?

Let's see what others thought of the same study.

Dr. Dean Ornish has an entire column in Newsweek - Why I Disagree with New Diet Study - where he voiced his concern that "many people may go on a diet that harms them based on inaccurate information;" and complained, as Dr. Sears did in numerous quotes, that study subjects assigned the Ornish diet weren't following the Ornish diet.

In the Forbes article about the study, Dr. Ornish summed up his belief that those on Atkins did better because "[i]t's a lot easier to follow a diet that tells you to eat bacon and brie than to eat predominantly fruits and vegetables."

Two diets, two authors, two not-so-happy campers.

What did Yale University food policy researcher and creator of the LEARN diet, Kelly Brownell, have to say? The study "shows that nothing works very well, [...] it just screams out for the need to prevent obesity."

One thing I do totally agree with - the study was a good concept...but it was poorly executed (Dr. Sears' main gripe).

That was one reason why, yesterday, I decided to forego detailing the data - it wasn't earth-shattering, it wasn't all that exciting and it really only proved - pardon my French - when you do something half-assed you get half-assed results.

I just could not get excited about it. The mouse study - A High Fat, Ketogenic Diet, Induces a Unique Metabolic State in Mice - in the American Journal of Physiology, Endocrine Metabolism; now that was exciting!

But I digress..

While Sears, Ornish and Brownell are all pointing out the lack of adherence to their respective plans, the same can be said of those assigned the Atkins diet; they didn't exactly follow the diet, as written, either.

In fact, at the two-month mark they were already consuming what is known as "pre-maintenance" or "maintenance" level carbohydrate - more than 60g per day on average.

Keep in mind this was during the initial eight week period that was designed to provide intensive support and teach participants about their assigned diets.

Those assigned the Atkins diet were not the only ones who failed to comply with the defined limits of their dietary approach - none of the groups seemed able to follow their diets correctly in the first eight weeks. Those assigned Ornish were to reduce dietary fat to 10% of calories - they ate 20%; those assigned the Zone were to eat 40:30:30 (carbohdyrate:fat:protein) and ate 42:35:23; and those assigned the LEARN diet were to eat what is similar to the Food Pyramid, around 55/60:30:10/15 and ate 50:30:20.

The question then must be asked - what happened in this study that subjects weren't able to follow the basic guidelines of their diets during the period of intense teaching and support? It's our tax dollars - this was an NIH funded study - so, how did a $2-million trial fail to achieve measurable compliance?

Forget about over the long-term, this study failed to achieve compliance out of the gate!

We have to ask, what went wrong?

If don't ask this question and probe the details, we'll just continue to waste money and get nowhere in answering the billion-dollar question - how do we help people lose weight and keep it off?

First let's look at the issue of compliance to an assigned diet protocol in other studies to see if this study is just one more with poor adherence or one more with a problem to resolve to achieve compliance in future studies.

If we look at other published studies for each of the above dietary approaches we find:

ORNISH

In the American Journal of Cardiology, the study - Comparison of coronary risk factors and quality of life in coronary artery disease patients with versus without diabetes mellitus - was published in May 2006. This trial included intensive support from the start to enable patients to modify lifestyle, diet, activity and stress management. Compliance was reported as good with the subjects "able to adhere to the recommended lifestyle."

ZONE - SEARS

In the American Journal of Clinical Nutrition, the study - Ketogenic low-carbohydrate diets have no metabolic advantage over nonketogenic low-carbohydrate diets - was published in May 2006. In the six-week trial we find good food intake was strictly controlled, so good compliance was built into the protocol.

LEARN (FOOD PYRAMID TYPE DIET 55/60:30:10/15)

In JAMA, the study, Low-Fat Dietary Pattern and Risk of Cardiovascular Disease - was published in February 2006. In the seven year trial we find the one year dietary data provided. In addition, we learn from the Dietary Modification Trial data, published in January 2006 (JAMA) that subjects in the intervention group received intensive support to learn their new diet over the first year and the first year data reported shows those in the intervention group consumed, on average, 24.3% of calories from dietary fat, 8.1% of calories from saturated fat, 58.3% of calories from carbohydrate, and the remaining calories - 17.7% from protein.

ATKINS

In the Annals of Internal Medicine, the study - A Low-Carbohydrate Ketogenic Diet versus a Low-Fat Diet to Treat Obesity and Hyperlipidemia - was published in May 2004. Both groups received printed materials and instruction from registered dietitians about their assigned diet protocol. The researchers reported that at the end of six months, the low-carbohydrate group consumed 29.5g of carbohydrate on average and the low-fat group (protocol less than 30% of diet from fat with a calorie deficiet of 500-1000 calories a day) averaged 29% of their calories from dietary fat and an average calorie intake of 1502-calories a day, a level within the desired deficit.

With the above studies, and many others with similar good compliance, one thing is abundantly clear - those tasked with instructing participants about their assigned diets knew the rules of the dietary approach well and were able to communicate, clearly, how to implement the necessary dietary changes to participants in the studies.

So what went wrong with this one?

As much as I hate to say it - if you ask me, it comes down to, as Dr. Sears said "pathetic execution" of the study concept because of a poorly designed protocol.

The researchers recruited women, aged 25 to 50, who had a BMI between 27 and 40, and who wanted to lose weight. This is good because the researchers started with a motivated population of participants. Motivation and desire to lose weight among study participants is a definite plus at the get-go of a study.

Then the researchers, following the gold-standard randomization protocol, blindly randomized participants into one of four groups, each assigned a popular diet book to use - Dr Atkins' New Diet Revolution, Enter the Zone, The LEARN Manual for Weight Management, or Eat More, Weigh Less by Ornish.

This is where I think things started to "go wrong" - those recruited into the study merely wanted to lose weight. Exclusions from the study included those whose weight was not stable over the last two months before the trial (already potentially dieting), those whose medications had changed in the last three months, and those who "self-reported hypertension (except for those whose blood pressure was stable using antihypertension medications); type 1 or 2 diabetes mellitus; heart, renal, or liver disease; cancer or active neoplasms; hyperthyroidism unless treated and under control; any medication use known to affect weight/energy expenditure; alcohol intake of at least 3 drinks/d; or pregnancy, lactation, no menstrual period in the previous 12 months, or plans to become pregnant within the next year."

Unlike other randomized trials with good compliance, these subjects did not have the additional motivation to reverse or improve a medical condition that would over-ride any doubts about a particular dietary pattern assigned to them.

In fact, if we examine the literature, we find when weight loss is the primary objective, compliance within randomly assigned diets is much lower than when subjects choose their diet or have the additional motivation to reverse or improve a medical condition.

We need to learn from this and not chalk it up as one more example that people can't follow a diet.

It's clear to me that blind randomization of subjects, in dietary modification trials, is less effective than allowing subjects to choose their diet if weight loss is the primary objective without specific disease management as a secondary objective.

Next we find in the A to Z Weight Loss Trial that participants did receive some instruction; specifically A) they were provided the book for their assigned diet, B) attanded a 1-hour classes led by a registered dietitian once per week for 8 weeks, and C) each class covered approximately one eighth of their respective books per class.

Curiously, "[t]he same dietitian taught all classes to all groups in all 4 cohorts."

I don't know about you, but I know me...and there is NO WAY I could objectively present and teach four vastly different dietary approaches without some bias seeping into my advice. It wouldn't be intentional either - I could definitely read and regurgitate Ornish's very low-fat, near vegan diet to an audience; I could definitely discuss how to plan a menu, shop and prepare dishes; and I could offer up meaningful suggestions about making good choices.

But....and here is the "but"....what participants would easily pick up on throughout my presentations is my lack of enthusiasm for the dietary approach. They'd also quickly realize I have no appreciable experience myself with eating that way or practical advice since I have not "been there, done that" but expect them to do it.

In this study, the same dietitian was tasked with and expected to provide expert instruction on each diet to each cohort - it's obvious from the abyssimal compliance at two months this approach to instuction about each diet did not work well.

We need to learn from this and not chalk it up as one more example that people can't follow a diet.

It's clear to me, from this study's method of instruction compared with other studies with better compliance, that it is not just knowledge of a diet that is necessary to teach someone how to follow a diet, but actual expertise of the dietary approach is critically important.

The person tasked with instructing a cohort must know not only the diet rules, but also how to plan menus, cook, shop, dine out, overcome objections from family and friends, and have practical advice to overcome obstacles that come along with any diet. Ideally they themself also eat a diet similar to that being taught and therefore have the "been there, done that" enthusiasm that does motivate someone that they can do it too.

After that intial eight weeks of instuction through group classes, we find the only additional communication was to motivate people to show up for follow-up - this communication with participants included telephone calls and emails reminding them of their follow-up appointments and monetary incentives to make their follow-up appointments. From week nine to the end of month twelve, there does not appear to be any additional support by way of classes, group sessions, or consultation to answer questions or provide advice.

We need to learn from this and not chalk it up as one more example that people can't follow a diet.

It's clear to me, from this study's method of follow-up support - or should I say lack thereof - that if we look at studies with good long term compliance, support over the long term goes hand-in-hand with choosing a diet you think you can do and expert instruction about how to do it.

Ask almost anyone who has followed a carbohydrate restricted diet for a long period if they did it without any support and they'll tell you support was critical along the way - whether by online forum, having access to someone expert in the diet rules or doing the diet with a spouse or friend - support got them through frustrations along the way as they learned their new diet.

Each of us, in some small way, through our taxes, paid for this study - a study that cost us $2-million dollars.

A study that tells us that you can lose weight in any diet you're told to follow for a year. Heck, it even tells us you can lose weight if you totally miss the boat with regard to how you're supposed to eat in the assigned diet as long as you don't continue to eat as you did in your habitual diet (baseline diet).

The media is trumpeting this as proof Atkins is better. Sorry, but this wasn't Atkins. It also was not Ornish, Zone or LEARN for that matter.

However, even with this criticism, I think it's safe to say that the study did meet it's primary objective to "test whether any of the 4 diets, representing a spectrum of carbohydrate intake, was more effective than any other in 12-month weight loss."

The carbohydrate intake of those assigned the Atkins diet - even though they did not reduce carbohydrate to Atkins level of intake - did in fact consume significantly less carbohydrate than the other groups while consuming a similar restricted level (without being told to do so) of calories. At each point in time, the Atkins cohort ate less carbohydrate, that correlates with greater weight loss observed at each data collection point. At the period between two months into the diet and one year, the Atkins cohort more than doubled their intake of carbohydrate from 61g at two months to 138g at one year. Even with this higher than encouraged level of carbohydrate, they lost weight - more weight than the other groups consuming more carbohydrate even with similar calorie intakes.

So before we write this one off as one more example of diets not working in the long-term, let's remember the participants did not have an opportunity to review each diet and choose one they felt they could adopt for the long term.

Let's also be aware that while the participants did recieve some instruction about how to follow their assigned diets, it's also fair to say the instruction was probably adequate, but certainly not from the perspective of "domain expertise" that may be critical to learning a new dietary approach in the long-term.

Lastly, let's not lose sight of the fact we'll continue to fail in our quest to find a method of weight loss and health risk improvement if we do not seriously begin to evaluate and understand what leads to good complicance or poor compliance.

Before we spend millions more on poorly executed diet studies, let's seriously evaluate the data and develop a set of best practices to help researchers avoid the pitfalls that are an inherent part of changing someone's diet.

People need motivation and a desire to lose weight.

People need to know their options, have information and make an educated decision about the type of diet they feel they'll do well with based on their dietary preferences and past experiences with different diets.

People need support to get started on a new dietary approach.

People need quality, expert instruction to guide them as they initiate a dietary modification, ideally from someone who is an enthusiastic expert.

People need support throughout the first year - support from experts and from others in the same boat as they are; online support forums, group face-to-face sessions, telephone access and personal consultations all contribute to success and must be considered as a critical component for compliance in dietary trials.

We have before us is a study that really does indicate carbohydrate restriction can work well over a period of one year. Without sub-group analysis to evaluate results tied to compliance (hey, some of the participants had to be doing the various diet right, dontcha think?) we can't know just how effective doing Atkins or any of the diets is with good compliance though since the researchers didn't take their data to that level of analysis in this paper.

What this study cannot tell us is how much better the outcome could have been - for any of the four diets in the trial - if participants had a chance to really have solid instruction and support.

Maybe next time we (taxpayers) fund a diet study, we'll include in the millions spent enough to include important and critical elements for success in the long-term?

Making the Rounds Around the Research of Low-Carb Diets

Over the coming hours and days, you'll have a smorgasbord of articles to tell you all about the soon-to-be-released study - Comparison of Atkins, Zone, Ornish and LEARN Diets for Change in Weight and Related Risk Factors Among Overweight Premenopausal Women (aka The A to Z Weight Loss Study) - being published in JAMA later today.

The results are already leaking out in various newspapers, so if you want a preview, you can read here or here or here.

While this study will be a media darling the next few days, I thought I'd highlight some other research that is just as important to our overall understanding of carbohydrate restriction, yet remains virtually ignored by the media!

I'll get to the JAMA study later this week since the findings really are nothing new nor a surprise to those of us who already understand that carbohydrate restriction works.

So, without further ado - in the March issue of Surgical Endoscopy, we find The effect of a low-carbohydrate diet on the nonalcoholic fatty liver in morbidly obese patients before bariatric surgery. In this study researchers investigated the effect of a very low-carbohydrate diet over four-weeks in 14 pre-op patients before bariatric surgery. All were morbidly obese and scans revealed non-alcoholic fatty liver disease (NAFLD).

NAFLD with enlargement of the left lobe of the liver can complicate bariatric surgery, so the researchers wanted to see the effect diet would have on liver density before surgery. After four weeks, there was a statistically significant increase in liver density and statistically significant decrease in liver volume. The researchers concluded, "The findings show that 4 weeks of a very low carbohydrate diet reduces liver fat content and liver size, particularly of the left lobe. This approach may render bariatric surgery or any foregut operations less difficult in morbidly obese patients and may be a useful treatment for nonalcoholic fatty liver disease."

Next up, in the February issue of American Journal of Physiology, Heart & Circulatory Physiology, we find Effects of Low Carbohydrate Diet on Vascular Health: More than just Weight Loss (pubmed citation) reviewing this study, Restoration of Coronary Endothelial Function In Obese Zucker Rats By A Low Carbohydrate Diet, published in the same issue.

In the latter, the study investigated endothelial function in obese rats fed a low carbohydrate or normal rat diet, the researchers concluded that "obesity-induced impairment in endothelial dependent vasodilation of coronary arterioles can be dramatically improved with a low carbohydrate diet most like(ly) through the production of a hyperpolarizing factor independent of NO." In the review (first link above) it was concluded that "Focardi et al demonstrates a novel mechanism of improved coronary vascular function with LC (low-carb) diet during metabolic syndrome. This study implicated a role for EDHF (endothelium derived hyperpolarizinf factors) in dietary interventions that may improve the cardiovascular complications of metabolic syndrome."

In simple English - the rats with metabolic syndrome did significantly better with a low-carb diet than their normal chow.

Another animal model study - A High Fat, Ketogenic Diet, Induces a Unique Metabolic State in Mice - in the American Journal of Physiology, Endocrine Metabolism, was a really cool study. In this study researchers compared the physiologic and metabolic effects of four different diets - normal chow (control group), a high-fat/high-sucrose diet, a ketogenic low-carb diet, and a calorie restricted (66% normal calories) optimal nutrition diet (CRON). The researchers found that the mice on the ketogenic diet ate the same calories as those on the control chow or the high-fat/high-sucrose diet, but their weight dropped and then stablized at 85% of their initial baseline weight - almost identical to those mice fed the CRON diet and allowed just 66% of their normal calories.

Mice grew obese on the high-fat/high-sucrose diet (remember, they were not eating more calories!) and when they were transitioned to a ketogenic diet, they lost their excess weight, improved glucose metabolism and increases energy expenditure. Need I say more?

Back in January, Metabolism published the study, Effects of a carbohydrate-restricted diet with and without supplemental soluble fiber on plasma low-density lipoprotein cholesterol and other clinical markers of cardiovascular risk, in which researchers investigated the effect of dietary fiber in a carbohydrate restricted diet (CRD). The researchers compared two groups of subjects following a carbohydrate restricted diet - group one was given a fiber supplement and group two a placebo; after 12-weeks both groups lost weight and body fat, improved systolic blood pressure, waist circumference and blood glucose levels.

Interesting finding - in both groups HDL and triglycerides improved (10% and -34% in fiber group; 14% and -43% in placebo group); LDL decreased by 17.6% at week 6 and 14.1% at week 12 in the fiber group; and a significant reduction, 6% happened at week 12 in the placebo group. As the researchers concluded, "We conclude that although clearly effective at lowering LDL-C, adding soluble fiber to a CRD during active and significant weight loss provides no additional benefits to the diet alone. Furthermore, a CRD led to clinically important positive alterations in cardiovascular disease risk factors."

So, while the rush will be on later today to pick apart and analyze the JAMA study, keep in mind it's not the first, nor will it be the last that confirms a carbohydrate restricted diet is a scientifically supported dietary approach for weight loss, cardiovascular improvement and improvement to blood sugars, cholesterol and the features of metabolic syndrome. It's also not the only recently published study investigating carbohydrate restriction or comparing it to other dietary approaches.