Currently browsing posts about: Sponsored-research

I love avocados but does their trade association really need to do research to encourage you to eat them?  Apparently so.

The study: Using the Avocado to Test the Satiety Effects of a Fat-Fiber Combination in Place of Carbohydrate Energy in a Breakfast Meal in Overweight and Obese Men and Women: A Randomized Clinical Trial.  Zhu L, et al. Nutrients 2019, 11, 952; doi:10.3390/nu11050952

Conclusion: “Replacing carbohydrates in a high-carbohydrate meal with avocado-derived fat-fiber combination increased feelings of satiety mediated primarily by PYY [satiety-inducing peptide] vs. insulin. These findings may have important implications for addressing appetite management and metabolic concerns.”

Funding: “This research was supported by the Hass Avocado Board, Irvine, CA, USA.”

Acknowledgments: “The planning, organization of the study as well as data analyses was performed solely by the investigators.”

Comment: Perhaps so, but, as I document in my book Unsavory Truth, an overwhelming body of research demonstrates that the biasing effect of industry funding occurs at an unconscious level and mostly occurs in the design of the research question.  The effect of the funding is usually unintentional and unrecognized, and typically denied.

Thanks to Effie Schultz for sending this one.

Oats do not typically contain gluten, the protein that produces toxic symptoms in people with Celiac Disease.  They do, however, contain a protein that may trouble some people with the disease, but the real problem is that they are often produced in places that also produce products containing wheat, or other grains that do have gluten.

Thus, I was interested to receive the following email from Stephanie Laverone, who describes herself as someone with Celiac Disease.  At my request, she gave permission to reprint what she sent me.

She sent me a link to a published commentary, Oat Consumption by Celiac Disease Patients: Outcomes Range from Harmful to Beneficial, Depending on the Purity of the Oats.  

In the conclusion, the authors explain that oats can benefit or harm people with Celiac Disease, but say that

The outcome appears dependent on the purity of the oats consumed. ..Regardless though, adding oats deemed GF [gluten-free] by these new high standards to CD [Celiac Disease] patient diets, may safely provide the benefit of broader dietary options, leading to improved GFD [gluten-free diet] adherence and quality of life, while bolstering nutritional deficiencies and potentially aiding heart health.

The authors’ Acknowledgment states:

Both authors are salaried employees of PepsiCo Inc. or Quaker Foods and Snacks (QFS), a subsidiary of PepsiCo Inc., which funded this research. QFS has a commercial interest in gluten-free foods. The views expressed in this manuscript are those of the authors and do not necessarily reflect the position or policy of PepsiCo Inc.

Ms. Laverone writes (I’ve done some light editing for emphasis):

Gluten Free Oats are controversial in the Celiac Disease community. There is a question of potential cross-reactivity to proteins found in oats that is further complicated by the high rate of cross-contamination of oats by gluten-containing grains.

There are two categories of gluten-free oats currently sold in the US: purity protocol and mechanically/optically sorted. Purity protocol oats are generally considered to be gluten free from field to store while mechanical/optical sorting involves the removal of gluten-containing grains during the processing stage.

Quaker Oats’ Gluten-Free Oats are mechanically/optically sorted (How does Quaker make Gluten Free Oats?).

It is obviously advantageous for Quaker Oats if:

(1) Safe consumption of GF oats by people with Celiac Disease simply relies on gluten testing, and

(2) Mechanically/optically sorted oats test positive for 20+ ppm of gluten less frequently than purity protocol oats, as implied by the final column of the table on the second page [of the Quaker Oats document].

Quaker Oats’ cereals may well be gluten-free.  Let’s hope so.

Gluten intolerance may be controversial—do people who think they are intolerant to gluten, really have problems with it?—but for people with Celiac Disease there is no controversy whatsoever.  Such people must avoid gluten.  Full stop.

What raises a red flag for me is the website statement, “As is always the case, the…safety of our consumers is our number one priority.”

Why the red flag?  That’s what they all say.

As Stephanie Laverone understood, this is another troubling example of the issues that arise from industry-funded research and, in this case, opinion.

Caveat emptor.

This is one of an ongoing series of examples of how industry funding skews, or to be more precise, is strongly associated with skewing, of research and opinion about matters of diet and health.

This example is an analysis of the scientific rigor of dietary approaches to controlling type 2 diabetes through diet.  The authors looked at the evidence for efficacy of the DASH, Mediterranean, Plant-Based, and Low-Carb diets.

Improving the Scientific Rigor of Nutritional Recommendations for Adults with Diabetes: A Comprehensive Review of the American Diabetes Association Guidelines Recommended Eating Patterns.  Hallberg S, Dockter NE, Kushner J, Athinarayanan S.  Preprints 2019.  Online March 5.  doi: 10.20944/preprints201812.0187.v2

Conclusion: “Our review of the current Standards and Recommendations finds significant shortcomings regarding scientific review methodologies, which are likely to translate to suboptimal clinical care decisions for patients with T2D.”  The study dismisses most studies of the DASH, Mediterranean, and Plant-based diets as poorly done or otherwise inappropriate for their review.  For the DASH diet, it says more research is needed.  It calls for more research on whether the benefits of Mediterranean diets are due to low carb or healthy fats, and suggests that the benefits of plant-based diets may be due to weight loss.  The best evidence supports the Low-Carb diet: “Evidence from 30 trials and 10 follow-up studies demonstrates that a low-carbohydrate diet is an effective dietary approach for addressing dyslipidemia.”

Conflict of Interest Statement:  SJH is an employee and shareholder of Virta Health, a for-profit company that provides remote diabetes care using a low-carbohydrate nutrition intervention, and serves as an advisor for Atkins Corp.  NED is a paid consultant for Virta Health.  JAK serves as medical director of McNair Interests, a private equity group with investments in type 1 diabetes and other chronic illnesses, and is also an advisor for Sanofi and Lexicon.

Comment:    All authors are employed by or consult for a company that uses low-carb dietary approaches in its for-profit business.  As I explain in Unsavory Truth, the influence of industry funding is often unconscious, unintentional, and unrecognized.  Nevertheless, the opinions of the authors can be predicted from their financial connections to Virta Health.

This is one of my ongoing updates of industry-funded studies such as those discussed in my most recent book, Unsavory Truth.

Here’s this week’s example:

Funding sources and outcomes of dairy consumption research – a meta-analysis of cohort studies: The case of type-2 diabetes and cardiovascular diseases.  Moshe Mishali, Mirit Kisner,Tova Avrech.  International Dairy Journal, accepted and in press 2019.

The study: The authors asked whether the source of funding was associated with the results of studies examining the association of dairy food intake with the risk of type 2 diabetes or heart disease.

Conclusion:  “This meta-analysis found that the funding source (i.e., food industry sponsorship versus neutral organisations sponsorship) did not affect the findings of studies in terms of the association between dairy consumption and the risk of developing type-2 diabetes and cardiovascular diseases…This meta-analysis suggests that research funded by the dairy industry might not deserve the same dismissive treatment that other industry-funded studies might merit.”

Funder: “This work was supported by the Israel Dairy Board Research – Fund (DBRF). Declaration of interest Moshe Mishali is a consultant for the Israel Dairy Board; Mirit Kisner was paid for her work by the Israel Dairy Board; Tova Avrech is Chief Health Officer at the Israel Dairy Board.”

Comment: This study was commissioned by the Israel Dairy Board specifically to address “The radicalised discourse that emerged in recent years [which] sees industry-funded research as inherently biased due to the obvious vested interests of any industry that initiates and funds certain studies…We sought to check if the suspicion is warranted when it comes to the dairy industry.”

These conclusions are consistent with those of Wilde et al (2012), although that study found that independently funded research included the only studies with results unfavorable to dairy (3 out of 16), whereas the industry-funded research came out 100% in favor of dairy products.

I would find the arguments about the benefits of dairy food more convincing if they were funded and conducted by investigators with no skin in the game.

After the debacle over Fifth Quarter Fresh that I wrote about in Unsavory Truth, you might think that sellers of chocolate milk would stop trying to prove it anything other than a sugary milk drink.  But no, here’s another one.

Chocolate Milk versus carbohydrate supplements in adolescent athletes: a field based study.  Katelyn A. Born, Erin E. Dooley, P. Andy Cheshire, Lauren E. McGill, Jonathon M. Cosgrove, John L. Ivy and John B. Bartholomew.  Journal of the International Society of Sports Nutrition (2019) 16:6.

Method: “Participants were randomly-assigned to receive either CM [chocolate milk] or CHO [carbohydrate] immediately post-exercise.”

Conclusion: “CM had a more positive effect on strength development and should be considered an appropriate post-exercise recovery supplement for adolescents.”

Funder: Dairy MAX [“nonprofit dairy council representing more than 900 dairy farm families across seven states”].

Comment: The premise of this study is that drinks containing a combination of carbohydrate and protein have been shown to provide better recovery from vigorous exercise than drinks containing carbohydrate or protein alone.  Chocolate milk contains both.  This study compared it to a carbohydrate-only sports drink, making this an excellent example of how to design a study to give you the desired result.

Unsavory Truth came out late last year, but I’m following up by posting recent examples of the issues it covers.  Here, for example, is a recent study that caught my eye:

The role of dietary sugars in health: molecular composition or just calories?  Philip Prinz. European Journal of Clinical Nutrition (2019).

A big argument in nutrition right now is whether the metabolic dysfunction that results from excessive consumption of sugars is due to the sugars themselves or to the calories they produce (or, I suppose, to both).

The author who attempted to answer this question conducted a lengthy and detailed review of research on the effects of sugars on obesity, heart disease, type 2 diabetes, and other chronic conditions .  His conclusion:

Current scientific evidence does not support the conclusion that dietary sugars themselves are detrimental to human health and the cause of obesity as well as NCDs [non-communicable— chronic—diseases]. Data from human studies clearly shows that it is the excess amount of calories, also consumed in form of dietary sugars, that promotes obesity and with that favors NCDs. For sucrose, further research is needed in order to evaluate the relevance of its molecular composition, especially in comparison with other macronutrients.

In other words, you don’t have to worry about sugars; just don’t overeat anything.

So, who paid for this?

The paper provides no disclosures of funding or conflicted interests.

But if you click on Philip Prinz, you will see that he is with the Department of Nutritional Sciences, German Sugar Association, Berlin, Germany

Comment

My interpretation of this literature generally favors calories (see my book with Malden Nesheim, Why Calories Count: From Science to Politics).  As I see it, when it comes to weight gain, how much you eat matters more than what you eat, especially if your diet is reasonably healthy.

But I would be much more confident in conclusions like these if they came from a researcher whose salary did not depend on producing desirable results for a sugar association.

And everybody would be better off eating less sugar, for reasons of nutritional health, if not necessarily weight.

Here’s another in my series of post-Unsavory Truth examples of studies whose funder can be predicted by their titles.

The consumption of 12 Eggs per week for 1 year does not alter fasting serum markers of cardiovascular disease in older adults with early macular degeneration Hassan Aljohia , Mindy Dopler-Nelson , Manuel Cifuentes , Thomas A. Wilson.  Journal of Nutrition & Intermediary Metabolism 2019;15:35-41.

Hypothesis: Egg consumption is associated with reduced risk of macular degeneration, but because eggs are so high in cholesterol, they might increase the risk for cardiovascular disease.

Conclusion: “This study suggests that the consumption of 12 eggs per week for 1 year does not significantly alter fasting serum lipids, lipoprotein cholesterol, or other biomarkers of CVD in older adults diagnosed with early macular degeneration” [the hypothesis is shown to be false].

Funding: “The authors would also like to thank the American Egg Board, Egg Nutrition Center, Washington, DC (T.A.W.) and the Massachusetts Lions Eye Research Fund Inc., New Bedford, MA (T.A.W.) for their funding support. The funding played no role in data collection, analyses, or interpretation.”

Comment: So the authors say, but industry influence is often unrecognized.    Independently funded studies sometimes come to quite different conclusions, as one in JAMA did last week.  Its conclusion: “Among US adults, higher consumption of dietary cholesterol or eggs was significantly associated with higher risk of incident CVD and all-cause mortality in a dose-response manner.”

Since my book Unsavory Truth came out late last year, I am posting occasional recent examples of issues I discussed in it.  Today’s issue: industry funding of research on potatoes of all things.

I am well aware that the role of white potatoes in the U.S. diet is hotly contested.   The EAT-Lancet report I wrote about recently advises against eating potatoes:

Potatoes, although containing large concentrations of potassium and some other vitamins, provide a large amount of rapidly absorbed carbohydrate, or glycaemic load. Daily consumption has been associated with increased risk of type 2 diabetes, hypertension, and weight gain.

Obviously, the potato industry would like to counter advise like that.  Its Alliance for Potato Research & Education is devoted to precisely that cause.  The Alliance explains that it is “Dedicated to advancing the scientific understanding of the role potatoes play in promoting the health of all people.”  It issues grants for up to $200,000 for “nutrition research proposals that help to advance scientific knowledge on the role of potatoes in various health outcomes” (the 2019 deadline just passed).

But I’ve just learned that the potato industry publishes its very own research journal: the American Journal of Potato Research.   It s subtitle: The Official Journal of the Potato Association of America, described as “A Professional Society for Advancement of the Potato Industry.”

Surprisingly, the papers in this journal are behind a paywall.  If the industry wants its research to be read and digested (sorry), I would think its papers would be open access (I was able to get this through NYU’s library).

One paper in particular caught my eye:

Invited review: Potatoes, Nutrition and Health.  Katherine A. Beals.  American Journal of Potato Research, 2018.  https://doi.org/10.1007/s12230-018-09705-4

Conclusion:  Until we have better research, “dietary guidance should continue to stress the importance of healthy eating patterns that consist of a variety of vegetables, including nutrient dense potatoes.”

Author’s funding disclosure: none.

Comment:  Evidently, this journal does not require authors to disclose funding.  Or perhaps every paper in this journal is sponsored by the potato industry?  Dr. Beals’ c.v. discloses consulting for the Potato Board.

I enjoy eating potatoes and view their effects on health as depending on how they are prepared, how much is eaten, and how often.

The purpose of potato-sponsored research is to cast doubt on studies suggesting that eating less of them would be better for your health.  When you see studies of potatoes and health, be sure to ask who paid for them.