Currently browsing posts about: Sponsored-research

I love blueberries and grow two different kinds on my 12th-floor Manhattan terrace, both delicious if I can get to them before the voracious birds do.

I wish the blueberry industry could just accept delicious and leave it at that, but no such luck.  It is desperate to get research it can use to promote blueberries as a superfruit (I wrote about the history of blueberry-funded research in Unsavory Truth).

Here’s the latest.

The study: Blueberries improve biomarkers of cardiometabolic function in participants with metabolic syndrome—results from a 6-month, double-blind, randomized controlled trial.  Peter J Curtis, et al. Am J Clin Nutr 2019;109:1535–1545.

Method: Participants were fed powdered blueberries equivalent to a half or full cup a day, compared to placebo.

Conclusions: Despite insulin resistance remaining unchanged we show, to our knowledge, the first sustained improvements in vascular function, lipid status, and underlying NO [nitric oxide] bioactivity following 1cup blueberries/d. With effect sizes predictive of 12–15% reductions in CVD risk, blueberries should be included in dietary strategies to reduce individual and population CVD risk.

Funder: Supported by the US Highbush Blueberry Council (USHBC) with oversight from the USDA and the Biotechnology and Biological Sciences Research Council (BBSRC, UK). AC and ERB both act as advisors to the USHBC grant committee. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

Comment: The press picked this one up:  “Study: Blueberries benefit heart health.”  This study used powdered blueberries.  Trust me, the fresh ones are much better.  You can tell this is an industry-funded study because the published study is open access, which somebody has to pay for—a clue that it is about marketing.  And what about the comment that funders had no influence?  They didn’t have to.  The study did not compare blueberries to any other fruits.  The science here provides some interesting information about how anthocyanins in this fruit might work, but wouldn’t they work the same way in any other fruit?  Are blueberries the only fruit that contains these particular anthocyanins?   This questions suggest that this study is not about the science, it is about demonstrating that there is something special about blueberries.  Dietary advice?  Eat whatever fruits you like.  And vegetables.  And nuts.  They all have something good about them.

Nutrition journals sometimes publish supplements on specific topics.  These are paid for by sponsors.  The papers listed here are part of a supplement to the May 2019 issue of Advances in Nutrition.

The sponsor?  As stated in the introductory article,

This supplement was sponsored by the Interprofessional Dairy Organization (INLAC), Spain. The sponsor had no role in the design of the studies included in the supplement; in the collection, analyses, or interpretation of the data; in the writing of the manuscripts; or in the decision to publish the results. Publication costs for this supplement were defrayed in part by the payment of page charges. The opinions expressed in this publication are those of the authors and are not attributable to the sponsors or the publisher, Editor, or Editorial Board of Advances in Nutrition.

Author disclosures: The authors have no conflicts of interest to declare.

The authors may think they have no conflicted interests, but as I discuss in Unsavory Truth, the effects of industry funding often are unconscious, unintentional, and unrecognized.

As is typical of industry-sponsored studies, the results of these dairy-funded studies are predictable.  From looking at these titles, you can predict that they will show dairy foods to have positive effects on pregnancy, lactation, child growth, bone density, and cognition, and no negative effects on mortality, metabolism, type 2 diabetes, cardiovascular disease, or cancer.

The overall conclusion is also predictable:

In conclusion, the systematic reviews and meta-analyses of the present supplement support adequate milk consumption at various stages of life and in the prevention/control of various noncommunicable chronic diseases.

If the dairy industry wants the public to believe these results, it should not be paying for them. 

Supplement—Role of Milk and Dairy Products in Health and Prevention of Noncommunicable Chronic Diseases: A Series of Systematic Reviews

• Introduction and Executive Summary of the Supplement, Role of Milk and Dairy Products in Health and Prevention of Noncommunicable Chronic Diseases: A Series of Systematic Reviews.  Ángel Gil ; Rosa M Ortega
• Effects of Milk and Dairy Product Consumption on Pregnancy and Lactation Outcomes: A Systematic Review.  María Achón; Natalia Úbeda; Ángela García-González; Teresa Partearroyo ; Gregorio Varela-Moreiras
• Effects of Dairy Product Consumption on Height and Bone Mineral Content in Children: A Systematic Review of Controlled Trials.  Carmela de Lamas; María José de Castro; Mercedes Gil-Campos ; Ángel Gil; María Luz Couce …
• Milk and Dairy Product Consumption and Risk of Mortality: An Overview of Systematic Reviews and Meta-Analyses.  Ivan Cavero-Redondo; Celia Alvarez-Bueno; Mercedes Sotos-Prieto; Angel Gil ; Vicente Martinez-Vizcaino …
• Effect of Milk and Other Dairy Products on the Risk of Frailty, Sarcopenia, and Cognitive Performance Decline in the Elderly: A Systematic Review.  Federico Cuesta-Triana; Carlos Verdejo-Bravo; Cristina Fernández-Pérez ; Francisco J Martín-Sánchez
• Effects of Milk and Dairy Products on the Prevention of Osteoporosis and Osteoporotic Fractures in Europeans and Non-Hispanic Whites from North America: A Systematic Review and Updated Meta-Analysis.  Pilar Matía-Martín; Macarena Torrego-Ellacuría; Angélica Larrad-Sainz ; Cristina Fernández-Pérez; Federico Cuesta-Triana …
• Dairy Product Consumption in the Prevention of Metabolic Syndrome: A Systematic Review and Meta-Analysis of Prospective Cohort Studies.  Guillermo Mena-Sánchez; Nerea Becerra-Tomás; Nancy Babio ; Jordi Salas-Salvadó<
• Effects of Milk and Dairy Product Consumption on Type 2 Diabetes: Overview of Systematic Reviews and Meta-Analyses.  Celia Alvarez-Bueno;  Ivan Cavero-Redondo; Vicente Martinez-Vizcaino; Mercedes Sotos-Prieto ; Jonatan R Ruiz …
• Milk and Dairy Product Consumption and Cardiovascular Diseases: An Overview of Systematic Reviews and Meta-Analyses.  Javier Fontecha; Maria Visitación Calvo; Manuela Juarez; Angel Gil ; Vicente Martínez-Vizcaino
• Association Between Dairy Product Consumption and Colorectal Cancer Risk in Adults: A Systematic Review and Meta-Analysis of Epidemiologic Studies.  Laura Barrubés; Nancy Babio; Nerea Becerra-Tomás ; Núria Rosique-Esteban; Jordi Salas-Salvadó
• Milk and Dairy Product Consumption and Prostate Cancer Risk and Mortality: An Overview of Systematic Reviews and Meta-analyses.  Bricia López-Plaza; Laura M Bermejo; Cristina Santurino ; Iván Cavero-Redondo; Celia Álvarez-Bueno …
• Milk and Dairy Product Consumption and Bladder Cancer Risk: A Systematic Review and Meta-Analysis of Observational Studies.  Laura M Bermejo; Bricia López-Plaza; Cristina Santurino ; Iván Cavero-Redondo; Carmen Gómez-Candela
• Milk and Dairy Product Consumption and Inflammatory Biomarkers: An Updated Systematic Review of Randomized Clinical Trials.  Stine M Ulven; Kirsten B Holven; Angel Gil; Oscar D Rangel-Huerta
• Role of Functional Fortified Dairy Products in Cardiometabolic Health: A Systematic Review and Meta-analyses of Randomized Clinical Trials.  María J Soto-Méndez; Oscar D Rangel-Huerta; María D Ruiz-López ; Emilio Martínez de Victoria; Augusto Anguita-Ruiz …

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.