As the leading government funder of nutrition research, the National Institutes of Health (NIH) is seeking public comment on a draft strategy to “coordinate and accelerate” clinical research over the next 10 years. This is a perfect occasion to contribute your thoughts and help guide NIH research towards important, unresolved issues in nutrition science.

This plan focuses specifically on clinical trials. While dietary policy to date has largely been based on epidemiological/observational studies, this kind of science can only serve, on the whole, to generate hypotheses. To test these hypotheses and provide more definitive proof, clinical trials are essential.

Thus, your contributions to this public comment period, which ends December 15, is an important opportunity to help direct the questions that might be tested in those trials.

The NIH Nutrition Research Task Force (NRTF) has prepared a draft plan that lists seven broad research themes:

Investigate nutritional biochemistry, physiology, and the microbiome Assess the role of nutrition and dietary patterns in development, health, and disease across life stages Explore individual variability in response to diet interventions to inform nutrition science, improve health, and prevent disease Enhance clinical nutrition research to improve health outcomes in patients Advance implementation science to increase the use of effective nutrition interventions Develop and refine research methods and tools Support training to build an outstanding nutrition research workforce

One clear oversight we have observed is that the plan emphasizes the need to study Dietary Patterns and only lists the Western, Mediterranean and vegetarian diets as examples worthy of research. The low-carbohydrate diet, which has proven in rigorous research to be one of the most promising options for reversing diseases, is not listed, and the plan de-emphasizes the need to study the health impact of specific nutrients. This may be due to the government’s long-standing bias against higher fat diets. Yet just as the USDA-HHS have included “low-carbohydrate” as one of the diets to be studied for the next U.S. Dietary Guidelines for Americans, we would suggest that the NIH be similarly open-minded to this emerging and promising science.

If you choose to comment, we suggest noting this omission.

IMPORTANT UPDATE DEC 3, 2018:

Several people submitting this comment to NIH have received emails in reply from NIH’s top official on nutrition, Christopher J. Lynch, Ph.D., Director, Office of Nutrition Research, NIDDK, Chief, Nutrition Research Branch, DDN, NIDDK, National Institutes of Health. Here is an example:

I am sorry that someone told you that sir. It’s a pity and also not true. Maybe whoever told you that, took something we wrote and twisted it for their own purpose or purposely changed the context. I am sorry you were told that. We have actually spent quite a bit of money in the last 5 years on studying many diets including keto-genic and low carb and high carb. That is one reason that the DGA committee will have enough literature to look at.

While it may be true that NIH has funded low-carbohydrate or ketogenic trials in the past (although our anecdotal knowledge of the field suggests that if so, it’s been very little), the NIH draft plan does not include plans to study either of these diets in the future. Searching the plan for “ketogenic” or “low-carb” turns up zero hits. Searching “carbohydrate” reveals only two mentions, neither related to studying low-carb diets.

“Increase training in food biochemistry and dietary glycomics and microbiota-accessible carbohydrates.” p. 58

and

“Glycomics: The study of the complement and sequence of sugars in complex molecules of an organism, food (e.g., dietary fiber, human milk oligosaccharide), or molecule. Glycomics includes the study of the genetics, biology, physiology and pathology of carbohydrates, and the set of techniques that facilitates such study.” p.62

Regarding nutrition and health in the draft report, the principal focus of the plan is on "Dietary Patterns,” which is “Theme 2,” referenced above (“Assess the role of nutrition and dietary patterns in development, health, and disease across life stages.”) In this section, the intention is introduced as.

“Foods and nutrients are consumed in a variety of combinations and can have interactive and potentially cumulative effects on health status. Dietary pattern research may focus on specific types of diets (e.g., Western, Mediterranean, vegetarian).” p. 30

There is no suggestion that low-carb diets be studied. “Low-carbohydrate” diets could be considered a dietary pattern, but they are not mentioned. And in fact, low-carb diets only awkwardly fall under the “Dietary Pattern” rubric because they are focused much less on specific foods than on macronutrient proportions. Searching the report for the word “macronutrient” turns up only one mention, in an unrelated context regarding infants (p. 41). Thus, the report in no way appears to embrace the future study of low-carb diets or macronutrient proportions as a means to achieve better health. Again, given the growing body of scientific literature showing the enormous promise of carbohydrate restriction in reversing nutrition-related diseases, and given the remaining unanswered questions, this oversight seems, in our view, quite grave.

We believe the facts support our characterization of the report. We welcome the views of Dr. Lynch, and we have opened up the comment section of this blog post for anyone who would care to comment/contribute.

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Back to our original blog post.

We also believe it is important for new research to provide clarity on other questions that challenge longstanding yet disputed advice. For instance, the majority of studies on salt have contradicted dietary recommendations calling for lower salt intake. Similarly, although calls to reduce red meat consumption are up, human trial data on meat thus far show no ill effects. Since these subjects remain contentious, more rigorous research is clearly needed.

Please offer comments to encourage clinical trial research on controversial topics that need further research.

Remember: your comments have made a difference in the past. They helped persuade USDA-HHS to put “low-carb” and “saturated fats” on the list of topics to be studied for the next Dietary Guidelines. Now is an opportunity to do the same with the NIH.

Responses must be submitted by midnight December 15. Here is the email for submissions: nutritionresearch@niddk.nih.gov.

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