Hello!
I am new to this forum. I have a B.S. in Nutrition, and am currently a grad student in Sports Nutrition and undergoing an internship to become a Registered Dietitian.
This is my 2-page scientific critique of an article that was in the Am. J. of Medicine in July 2002, volume 113. It is freely accessible from Pubmed.
This was the one study that was widely reported in the media and funded by Atkin's himself. As a future professional, I have a sincere interest in making sure that the public have accurate and reliable information, especially because we don't know the long-term effects of such a diet. Please read and thank you for your consideration:
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The results of this problematic study have been extensively reported within the media during the last year. The study examined the effects of six month’s adherence to a very low carbohydrate diet; however the methodology employed was not appropriate for the evaluation of causality for weight loss. Specifically, the poor experimental design, relaxed and unrestrictive intake, funding source and lack of controls make for unsound research results.

A 25g carbohydrate/day diet was initially carried out until 40% of each subject’s self-determined weight loss target was achieved, where in which carbohydrate intake was increased to 50g/day. Given that each subject had different weight-loss goals, the actual number of days that any individual remained on the 25g carbohydrate/day program (versus the 50g/day) was not quantifiable. As an alternative, a fixed time period for each diet (or relative target weight loss) should have been arbitrarily assigned for all subjects.

Second, no restrictions were placed on daily caloric intake. The daily recommended intake of 1,905 kcal was based on an average of subjects’ height and sex. According to food records however, the mean daily energy intake was only 1,447 + 350 kcal. This caloric reduction was anticipated, owing to the fact that the original diet consisted of unlimited amounts of meat, fish, eggs and cheese. Considering that protein foods elicit the greatest level of satiety and that subjects were instructed to eat until their hunger was relieved, it is logical to expect subjects to consume less. Researchers in the study own up to this, stating in their discussion that the diet would have been more appropriately labeled as a “ketogenic, low-calorie diet.” Classifying the program as a “very low carbohydrate diet” is not only misleading, but neglects all-inclusive mechanisms for weight loss exploited within the study.

The discussion of the study reports that insignificant yet beneficial effects on serum lipid profiles were observed from baseline to six months. Interestingly, the researchers offer no connection between this finding and the ‘essential oils’ or ‘diet formula’, which were administered throughout this study three and six times daily, respectively. A daily dose of the supplements included 3600 mg flaxseed oil, 3600 mg fish oil, and 54000 mg soy extract, all of which have cardio-protective effects.

Research has linked omega-3 fatty acids (like flaxseed and fatty fish oils) to cholesterol and blood triglyceride reduction, both risk factors for heart disease. In addition, omega-3’s may reduce blood pressure. Soy protein extract has also been demonstrated to alter cholesterol metabolism and inhibit LDL oxidation. These ingredients are barely mentioned in the article’s Appendix. Moreover, one subject had an increase in LDL cholesterol from 123mg/dL to 225mg/dl. Excluding this subject is like eliminating an outlier, and could be regarded as data clipping.

The study imparts that significant weight loss occurred in 95% of subjects, both in fat-free mass and fat mass. Standard skin-fold calipers were used to estimate fat mass. A major source of error in anthropometrics lies not within the imprecision of this instrument, but in the actual taking of the measurements. The standard error for this method (when performed by a well-trained technician) is 3-5%. The percentage of weight loss in subjects that was fat decreased was only 2.9% + 3.2%, meaning the fat mass reduction observed was less than the percentage of standard error itself.

Finally, the funding for this study was provided by The Atkins Center for Complementary Medicine. Slightly suspicious, bearing in mind that the diet utilized in the study corresponds with diet recommendations endorsed by Dr. Richard Atkins. Since the source of funding was hardly disinterested in the outcome of the study, there may have been some inherent bias toward results that promote the special interests of The Atkins Center.

Although other limitations exist (program non-compliance, increased exercise habits, adverse side-effects including ketosis and constipation) the critical flaw within the experimental design remains: there was no control (unexposed) group for comparison. This study’s inability to assess the presence or absence of causal relationships between very low carbohydrate diets and weight loss is precisely what makes it severely methodologically limited.

I welcome comments/concerns. Thank you! Future RD

What were the readings on HDL and triglycerides?
Why is ketosis an adverse side effect? Constipation is easily remedied by eating fiber rich vegetables.
Who is Dr. Richard Atkins? Never heard of him!

Karen

Dr Richard Atkins? Who's he? If you don't know that the good doctor's name was Robert Atkins, it makes me wonder a little about the accuracy of the rest of your critique...

The only other point I'll bother to address is that Dr Atkins was criticized for years for not conducting any research. So of course, when the Atkins Center did fund some research, they were roundly criticized for that too.

Have you read any other research about low carbing? I suggest you start at "Low Carb Studies" on the orange bar at the top of the screen.

Rosebud

If the only criticism you have of my review is the fact that I was misinformed about Dr. Atkin's first name, that is worthless, no offense.... I do however appreciate the fact that you read my whole paper.

FYI, I have read a MAGNITUDE of studies on low-carb diets, as I am currently writing my thesis design/proposal for a protocol based on exercise responses to a low-carbohydrate diet.
As a suggestion, it would be great if there was a link to the entire article, instead of just the abstracts, so that viewers could enquire about the methodology of each study and decide if it was legitimate or not...an abstract is a very limited summary. Also, it is worrisome that many of the articles available on the website promoting these diets haven't even been PUBLISHED by a peer-reviewed journal; they are merely done by researchers. That alone is questionable, because it means the studies weren't subject to a review commitee.

Karen,
A sinificant increase in HDL's and decrease in Triglycerides was observed in this study, with an average change from Baseline to 24 weeks of: +10mg/dlL and -56mg/dL, respectively.
These improvements however, are UNDERMINED by the fact that all subjects consumed 3600mg flaxseed oil+ 3600 mg fish oil +54000mg soy extract, NINE TIMES DAILY for the entire length of the study.
Surely, each one of these supplements have independent and additive beneficial effects on these parameters (TG and HDL's), especially when administered so freqently throughout each day. Such large supplemental doses are not practical or affordable for regular persons on similiar diets.
I won't even adress the Richard vs. Robert Atkins goof.....
you've gotta think of something better than that!

do you really think that because the source of funding had an interested outcome in the study, that it may have had some bias ? i don't believe people are that dishonest. of course, i have been known to wear rose-colored glasses !!!!!!!

Funny how my bad cholesteral level went down, My good cholesteral went up , my trigycerides went down, my glucose level went down with LC dieting and I did not take "3600mg flaxseed oil+ 3600 mg fish oil +54000mg soy extract, NINE TIMES DAILY" In fact I took no supplements except a standard one a day vitamin. The only fish I ate was a small can of tuna twice a week. I also ate no soy products. I ate eggs with cheese bacon or sausage every day at breakfast for 3.5 months and lost 37 lbs.

Also I have read that Atkins money funded the study but did not control how it was done. Rosebud said it well and in my words the cliche damed if you do damed if you don't.

How come Nutritionists are so clueless?

All my Doctors are having success with LC WOE.

Why is this a flaw? It seems to lend credibility to what Atkins and others have been saying about replacing high carbohydrate foods with low ones...the average persion will simply eat less on a low carbohydrate diet. Moreover, should the average participant have been tied down and force fed an additional 108 kcal to get them up to the "mean daily energy intake?" Otherwise, why not simply admit that the participants ate less because, they *gasp!* weren't hungry.



What voluntary study does NOT have issues with people dropping out, (if that's what "program non-compliance" is)? To what extent was that an issue in this study, and what is it in a "typical" study, (however defined)? I'm curious. Since you raised this as an issue, I assume you know the answers.

Oh, and please show us how ketosis is an "adverse side effect."



I know next to nothing about how diet studies are created or conducted. Do they typically establish or disprove causal relationships? I thought studies fo this sort typically only tried to describe correlations of data, but perhaps I'm wrong.

Faust:
Yes, the subjects weren't as hungry , and that is why they ate less. This means that any weight loss was due to the severe caloric restriction, not the fact that is was "low-carbohydrate". A calorie is a calorie, regardless of where it came from; such caloric defecits will always induce weight loss.
Also; a word about why ketosis is an "adverse side effect":
Ketosis is the incomplete oxidation of fat, and is not an ideal situation. With very-low carb diets, the liver's glycogen supply is exhausted (this can happen overnight) in attempt to maintain blood glucise levels, and the brain and the kidneys DEPEND heavily, if not solely, on glucose for fuel.
Beacuse the enrtry of fatty acids into the brain is very limited, muscle strats to be catabolized to provide the materials to make glucose. This loss of lean tissue cannot be maintained long.
Further, very high levels of ketones in the blood will affect an individual's biochemistry and physiology because they are acidic.
Garey:
I am VERY glad that you saw favorable changes in your lipid profile; remember that the reason I posted this article critique in the first place is because I care about public health, so please don't misunderstand my genuine intentions. I see that you have ony been on the diet for 3.5 months; it would be warranted then, for you to see what your lipid profile reflects after 6 and 12 months on this same diet. Also, have you exercised since you've been on the diet? Exercise seems to be the only way to lower TG indefinitely. I wish you the best of luck; my father is on this diet and thats another reason why I care so much!

sorry for the spelling error, I had reply quichkly before class!!!!

Go ahead, peck away at this study all you want. You'll have maybe six more to attack right after that, all consistently showing pretty much the same results. (Start with Volek, J.S., Sharman, M.J., and Gomez A.L., et al., "An Isoenergetic Very Low Carbohydrate Diet Improves Serum HDL Cholesterol and Triacylglycerol Concentrations, the Total Cholesterol to HDL Cholesterol Ratio and Postprandial Lipemic Responses Compared with a Low Fat Diet in Normal Weight, Normolipidemic Women," The Journal of Nutrition , 133(9), 2003, pages 2756-2761. . . .Brehm, B.J., Seeley, R.J., Daniels, S.R., et al., "A Randomized Trial Comparing a Very Low Carbohydrate Diet and a Calorie-Restricted Low Fat Diet on Body Weight and Cardiovascular Risk Factors in Healthy Women," The Journal of Clinical Endocrinology and Metabolism , 88(4), 2003, pages 1617-1623. . . . Stern, L., Iqbal, N., Chiceno, K., et al., "The V.A. Low Carbohydrate Intervention Diet (VALID) Study," Journal of General Internal Medicine , 17(S1), 2002, pages 147-148. . . . they go on and on.)

But never mind any of that. I didn't choose this way of eating because of what some study said, anyway. I simply found that eating low-carb (or high fat, whatever you want to call it) solved a lifelong problem I had with weight control. Nothing that dieticians told me did any damn good. Ever. They tsked and tsked, but never had anything better to say than don't eat fat, eat five times a day, and don't eat fat.

I've had no less than three dieticians condemn my low-carb way of eating saying it would result in all sorts of dire consequences. None of those dire consequences happened. Not one. Except I lost weight, improved my lipid profile, increased my stamina and energy, lost my cravings. It's been FIVE years now, and things just get better. All without the potatoes, rice, beans, bread, and bananas. And eating PLENTY of fat. And I DON'T eat breakfast, the most important meal of the day in the RD mantra.

I pay no attention to the clucking of RDs any more. They have no credibility with me. (Personally, I think what RDs and nutritionists practice is more like religion than science. They believe what they believe, and ignore or refute any evidence to the contrary.) Nothing a dietician every told me to do worked for very long. And when it didn't they told ME I was wrong.

If RDs are such damned geniuses and know-it-alls, how come THEY haven't come up with any good ideas for helping people with obesity? By that I mean a program or an approach that (1) actually WORKS in the real world (not in metabolic wards) and that (2) works so well that people actually WANT to keep doing it, and tell their friends about it. And don't point to that drivel on the ADA web site. It's out of touch with REAL people. They have failed miserably.

If you asked me, RDs have a HUGE credibility problem. They're stuck with the eat vegetables/don't eat fat/don't eat meat thing. . . and can't get past it

I have been doing LC WOE for 1 year and 7 months maintaining my weight after the weight loss. My lipid levels that I mentioned were checked 1 year after I started. All during this first year I did not excersize at any level different than before the diet - actually less. The 3.5 month I referred to was the induction period during which I lost my weight to reach my current target. I went directly from Induction to Maintenance - unable to do OWL. I stay very close to induction with my metabolism. After the first year I increased my excersize but still maintain at the same weight. I have found through the years that I can not lose any significant weight with excersize that I can fit into my lifestyle. My weight loss success came strictly from LC eating and it was dramatic. I lost 18 lbs in the first month.

Again the lipid readings were after 1 year - 3.5 months induction and 8.5 months maintenance. They agreed with the findings of all the recent LC studies.

I was trained as a scientist and am analytical. To me this was a science experiment. I did not consult my Doctor. I did it cold turkey with induction. After a couple days I started losing - in the first month sometimes I lost 2 lbs a day in successive days. It was truly amazing. Nobody could tell me this LC WOE does not work to lose weight. I had to gather my pants around my back. I went from 38 waist to 34.

I have a friend who is doing the same thing - he is diabetic. Not only have his lipids improved but he is off insulin.

Good luck on your research!

Well, fair enough for future rd to examine the study critically. That's the way the academic/scientific world is supposed to work. Someone does a study, others may try to replicate it, or control things that weren't controlled. However, just for the record note that this was mostly never done in devoloping the orthodox dogmas of the nutrition world. Uve Ravsknov looked at the studies used in setting the diet-heart hypothesis in stone, found they just don't say what is claimed. Likewise, pick on this study because it was funded by Atkins? How about Ornish? his reputation for "scientifically proven to reverse heart disease" rests on three studies done by himself. He has people lose weight, stop smoking, exercise, reduce stress. And has the crust or naivete to say it is from eating silage not fat. Anybody ever try his 4 things, only the weightloss from, say Slimfats, WW or Atkins? There's no science there at all. Anyhow, like I said, its fine to critique the studies, but perhaps I sort of sense a budding prof. dietician in the making, "eat the crust, throw away the toppings." "base your diet on starches" etc. etc. Thank God for Dr Atkins and Dr Bernstein, my blood sugars are NORMAL, and if anyone can show me a study where type 2 diabetics attained NORMAL sugars with no medication, while consuming 200-300 g carbs per day, then I will eat my (lowcarb) hat. It can't be done, any more than you can reduce a drunk's blood alcohol by giving him 6-10 servings of rum per day.

Wrong!
Have you ever heard of gluconeogenesis? That is the process by which the body makes any glucose necessary for use as fuel for organs from protein. And as we low carbers eat plenty (not necessarily "high," but plenty) of protein, our bodies have no difficulty manufacturing glucose as needed.

Oh dear, you are making the very basic mistake of confusing ketosis with ketoacidosis.
Two totally different conditions.
If you are so uninformed about this as to trot out that tired old warning, I can only smile.
Please do a little more research. You'll find plenty here on this site about the difference between the two. Just use the at the top of the page.

Rosebud

And I will be right alongside you doing the same. The amount of carbs my registered dietician allowed me as a diabetic borders on criminally negligent and knowing what I know now, it's not a big mystery to me why my blood sugars wound up out of control with my insulin resistance being quite a bit wosened following exactly what I was told to do. My fasting blood sugars seemed to stay normal for a while, but my post prandials swung wildly..I had no fats or proteins to moderate the glycemic index of the foods that I was being told to eat; 2 teaspoons of fat per day and 4 oz. of protein. Any weight loss I experienced was probably largely muscle mass on that plan.
You're right...it makes absolutely no sense to take a person who has a problem with carbohydrate metaoblism by the nature of the disease that they have and tell them to eat mostly carbohydrates and that it's those evil fats and proteins that they must limit instead. Nor does it make much sense to take people who are obese and already have high triglyceride levels and instruct them to eat in a manner that will do nothing to help that problem and in many cases just might make it worse.