Currently browsing posts about: Sponsored-research

The study: Impact of low-fat and full-fat dairy foods on fasting lipid profile and blood pressure: exploratory endpoints of a randomized controlled trial.  Kelsey A Schmidt, et al. The American Journal of Clinical Nutrition, nqab131, https://doi.org/10.1093/ajcn/nqab131.  Published: 13 July 2021

Background: “Dietary guidelines traditionally recommend low-fat dairy because dairy’s high saturated fat content is thought to promote cardiovascular disease (CVD). However, emerging evidence indicates that dairy fat may not negatively impact CVD risk factors when consumed in foods with a complex matrix.”

Method: “Participants were then randomly assigned to 1 of 3 diets, either continuing the limited-dairy diet or switching to a diet containing 3.3 servings/d of either low-fat or full-fat milk, yogurt, and cheese for 12 wk.”

Conclusions: “In men and women with metabolic syndrome, a diet rich in full-fat dairy had no effects on fasting lipid profile or blood pressure compared with diets limited in dairy or rich in low-fat dairy. Therefore, dairy fat, when consumed as part of complex whole foods, does not adversely impact these classic CVD risk factors.”

Funding: “National Dairy Council, Dairy Farmers of Canada, Dutch Dairy Association (Nederlandse Zuivel Organisatie), Dairy Australia, and the French Dairy Interbranch Organization (CNIEL),” and NIH and others.

Conflict of interest: “This study was initiated by the principal investigator (MK). The dairy-related funding organizations suggested changes to details of the study design prior to the conduct of the study, some of which were implemented. Otherwise, the funding organizations had no impact on the design or conduct of the trial or the analysis and interpretation of study data.”

Comment: Let’s give these investigators high marks for disclosing that the dairy funders influenced the design of the study, which, as we know from the data of Lisa Bero and her colleagues, is the place where biases caused by industry funding most typically show up.  Food companies that fund research are looking for benefits; they won’t risk study designs that might yield inconvenient results.

Reference: For a summary of research on the “funding effect”—the observations that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests and that recipients of industry funding typically did not intend to be influenced and do not recognize the influence—see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

I know I’ve already posted one of these this week, but this one is too good not to share.

Let’s start with the press coverage: Snack yourself young: Study investigates the effects of daily almond consumption on wrinkles

A study by American research found that eating almonds daily reduces wrinkle severity – along with improving skin pigmentation – in postmenopausal women.

The 2021 study – published in Nutrients and funded by the Almond Board of California – expands upon findings of a 2019 study​​ that found there may be more than one reason to add almonds to a daily skin care routine.​​

And here’s the study in question: Prospective Randomized Controlled Trial on the Effects of Almonds on Facial Wrinkles and Pigmentation.  Authors: Sivamani RK, Rybak I, Carrington AE, Dhaliwal S, et al.  Nutrients. 2021; 13(3):785

This is not their first on this topic.  See: Prospective randomized controlled pilot study on the effects of almond consumption on skin lipids and wrinkles.  Author: Sivamani RK, Foolad N, Vaughn AR, Rybak I, et al   Phytother Res. 2019 Dec;33(12):3212-3217

Nor are these the first studies to link specific foods to wrinkle prevention.  I’ve written previously about a study on mangos and wrinkle prevention, sponsored—of course—by a mango trade association.

I wish companies and trade associations would stop doing studies of one food and some health outcome. Diets that contain reasonable proportions of fruits, vegetables, and whole grains are demonstrably healthy.  Can any one food really make all that much difference?

The sellers of these foods would like you to think they are “superfoods.”  Alas, no such thing exists.  But it’s a great marketing strategy.

As for sponsored research in general?

For a summary of research on the “funding effect”—the observation that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests but that recipients of industry funding typically do not recognize its influence—see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

I was of course interested to see this press release from Nature:

Health researchers report funder pressure to suppress results: Small study hints that interference from bodies funding research into public-health issues such as nutrition and exercise might be more common than realized.

It referred to a study published in PLoS One: ““He who pays the piper calls the tune”: Researcher experiences of funder suppression of health behaviour intervention trial findings.”

This was a small study, but its results confirm what has long been suspected.  Funders call the tune.  These results are entirely consistent with those from similar examinations of studies paid for by cigarette, chemical, and drug companies, as I discuss in my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

My NYU colleague Mitchell Moss sent me this notice of new research: Eating just 5 prunes a day reduces risk of heart disease, inflammation.

That was worth tracking down and I soon found a press release from the California Prune Board: New study: Eating prunes daily improves risk factors for heart disease and inflammation

In a statement, the senior author says:

In this randomized, controlled study, researchers found that eating 50 grams of prunes (about 5-6 prunes) each day for just 6 months resulted in improved CVD risk biomarkers – including raising the body’s “good” cholesterol, known as HDL, and lowering the ratio of total cholesterol to HDL. Eating prunes daily also promoted higher antioxidant capacity and lowered levels of the inflammatory cytokines interleukin-6 and tumor necrosis factor-alpha associated with CVD risk. Notably, body mass index and weight of the study participants were maintained during the trial despite adding prunes to the usual diet.

The study:  Dried Plum Consumption Improves Total Cholesterol and Antioxidant Capacity and Reduces Inflammation in Healthy Postmenopausal Women

Dietary intervention: “48 postmenopausal women were randomly assigned to consume 0, 50, or 100 g of dried plum each day.”

Results: “After 6 months of intervention, total cholesterol (TC) in the 100 g/day treatment group (P = .002) and high-density lipoprotein cholesterol in the 50 g/day treatment group (P = .005) improved significantly compared to baseline.”

Conclusion: “…consumption of 50–100 g dried plums may improve CVD risk factors in healthy postmenopausal women by increasing total antioxidant capacity and antioxidant enzyme activity, lowering lipid peroxidation, and lowering IL-6.”

Authors’ statement: “The authors declare that there is no conflict of interest.”

Funding: “This study was funded by the San Diego State University Grant Program, the California Dried Plum Board (No. 57114A; ClinicalTrials.gov, No. NCT02325895), and the Kasch-Boyer Endowed Scholarship in Exercise and Nutritional Sciences in San Diego State University.”

Comment:  Add prunes to the long list of fruit-and-vegetable trade associations trying to convince you that their particular product has unique health benefits.  Prune sellers have a particular difficulty with sales: prunes have long been equated with laxatives.  Hence: the Dried Plum Board.  Also hence: health benefits beyond the digestive tract.

Do prunes have more general health benefits?  Why not?  All fruits and vegetables have health benefits.  Is one better than another?  Maybe in some ways, but the best approach is to eat as wide a variety as possible.

Eat the fruits you like!

Reference: For a summary of research on the “funding effect”—the observation that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests but that recipients of industry funding typically do not recognize its influence—see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

One Potato

Thanks to David Ludwig for alerting me to an e-mail from the Alliance for Potato Research & Education (APRE), a trade association “dedicated to advancing the scientific understanding of the role potatoes play in promoting the health of all people.”

A new APRE-funded study published in Nutrients investigated the effect of increased dietary potassium from a whole food source – baked/boiled potatoes and baked French fries – or a potassium supplement on blood pressure and other cardiovascular disease risk factors compared to a ‘typical American’ control diet (lower potassium intake) among 30 pre-hypertensive-to-hypertensive men and women.

Results showed that baked/boiled potato consumption had the greatest benefit on reducing sodium retention, even more than the supplement, and resulted in a greater reduction in systolic blood pressure (SBP) compared to the control diet.

Further, despite commonly held misbeliefs about French fries and their role in heart-healthy lifestyles, the authors observed that a 330-calorie serving of baked French fries, when eaten as part of a ‘typical American’ diet, had no adverse effect on blood pressure or blood vessel function.

The study concludes:

This was the first controlled feeding study of potassium from food and supplements on BP and CVD outcomes in an unhealthy population…Of public health relevance is our observation that French fries in amounts typical of a large serving in a fast food restaurant has no adverse effect on blood pressure or endothelial function.

It discloses the funding source: “This research was funded by Alliance for Potato Research and Education.”

Comment: Because some (but not all) observational studies have linked potatoes, and especially French fries, to poor health outcomes, the potato industry wants research to give these foods a healthier image.  This study says that potatoes are high in potassium and a high potassium-to-sodium ratio is good for blood pressure and heart disease.  I could have told them that on the basis of food composition data alone: 100 grams of French fries contains 435 mg potassium versus 295 of sodium.  Does that make French fries a health food?  No, alas, it does not.

Once more for the record: industry-funded research is about marketing, not public health.

Two Potato

Last week, I received an emailed notification from APRE, the Alliance for Potato Research & Education announcing a new study.

For decades, people have often associated higher intakes of carbohydrate-containing foods with less healthy lifestyles. Yet, evidence suggests this view is overly simplistic, and it is instead the type and quality of carbohydrate foods that matter most for supporting health…In a newly published perspective in Nutrients, a group of nutrition researchers, who collectively make up the Quality Carbohydrate Coalition-Scientific Advisory Council (QCC-SAC), outline the opportunity for a stronger, more evidence-based approach to defining quality carbohydrate foods to support overall health and provide clearer dietary guidance.

The study: Toward an Evidence-Based Definition and Classification of Carbohydrate Food Quality: An Expert Panel Report.  Kevin B. Comerford, Yanni Papanikolaou,  Julie Miller Jones, Judith Rodriguez. Joanne Slavin,  Siddhartha Angadi.  and Adam Drewnowski.  Nutrients2021, 13(8), 2667.

Conclusion: The identification of higher quality carbohydrate foods could improve evidence-based public health policies and programming—such as the 2025–2030 Dietary Guidelines for Americans. 

Feed the Truth (FTT), an organization I’ve discussed previously and whose mission is to work “at the intersection of equity, democracy, and food justice to stop corporate control over the food we eat,” has just come out with the results of its new research on Big Food’s lack of transparency in political giving.

FTT attempted to discover the political spending levels of the ten largest food and agriculture corporations: ADM, Bunge, Cargill, Coca-Cola Company, JBS, Mars, Nestle, PepsiCo, Inc., Tyson Foods and Unilever.

FTT’s unsurprising conclusion: “despite the massive influence these corporations have on our health, economy, and the environment, there is very little publicly-available information about how they manipulate the political system to their advantage.”

This led FTT to develop The Food and Agriculture Corporate Transparency (FACT) Index.  This ranks the transparency of the corporations on a scale of zero to 100 on readily available disclosure of their spending on electioneering, lobbying, science, and charity.

Among the key findings:

Overall transparency scores:

• Total: 2 (Bunge, Tyson) to 39 (Coca-Cola)
• Electioneering: 0 (Bunge) to 20 (Mars).
• Lobbying: 0 (Bunge, Tyson) to 9 (Coca-Cola)
• Charity: 0 (Unilever, ADM) to 8 (Coca-Cola)
• Science: 0 (PepsiCo, Mars, Unilever, JBS, Bunge) to 8 (Nestlé)

Coca-Cola ranks highest in part because of the transparency initiative it started in response to the furor over disclosure of its role in the Global Energy Balance Network.

I could have told FTT how hard it is to get information about food industry funding of science as well as all the other ways it uses funding to influence attitudes and policy.  I had my own version of these difficulties doing the research for Unsavory Truth: How Food Companies Skew the Science of What We Eat.

It’s great that FTT is bringing this problem up to date, and identifying what needs to be done about it.

Thanks to Frank Lindner for sending this study.  He is a campaigner for foodwatch Nederland, which among other campaigns, runs Stop the sale of science for better transparency in science.

He says this Tweet made him curious:

He followed up and found the study: The place of animal products in a sustainable diet.  Authors: Stephen Peters, Jolande Valkenburg, Thom Huppertz, Luuk Blom, Lionel van Est. Norwegian Journal of Nutrition, Nr. 2 – June 2021.

The study begins with this premise:

Replacing animal-based foods with plant-based foods does not necessarily lower the diets [sic] carbon footprint.

Why?

In an average Dutch person’s diet, animal products are an important source of protein, minerals and vitamins…Animal products contribute significantly to the intake of important nutrients, such as high-quality protein, vitamins A, B2 and B12, calcium, magnesium, zinc and (in the case of meat) heme iron. These nutrients are not naturally, or often, found in plant products. Omitting animal products from the diet therefore can have major consequences for nutrient intake.

Lindner wrote that “I read the article and my jaw fell wide open at the very end….”

Funding: The research has been sponsored by the Dutch Dairy Association.

Conflicts of interest: Dr. Peters is a employed by the Dutch Dairy Association as manager of dairy health and sustainability. Dr. Huppertz is employed by FrieslandCampina, The Netherlands and is a professor of Dairy Science at Wageningen University and Research, The Netherlands, Distinguished Visiting Professor at Victoria University, Australia and Editor-in-Chief of International Dairy Journal. Dr. Bloom and Dr. van Est are the founders of Nutrisoft. A (commercial) company that combines the knowledge of nutrition and ICT.

Comment: FrieslandCampina is a large dairy cooperative operating in 38 countries and employing nearly 24,000 people.   It sponsors research at Wageningen University.

Milk and dairy may be at the heart of what we do, but at FrieslandCampina, we make more than just cheese and yogurt. We also produce dairy nutrition for specific groups of consumers, such as toddlers or adults with specific requirements.

Lindner was surprised by the disclosures and said “At least they are open and honest about it (they don’t even bother to hide it).”  He should not be surprised.  Industry-funded studies almost always produce results favorable to the sponsors’ interests.  That is one reason why journals require authors to disclose financial relationships with sponsors.

Here, the interests are obvious.  It is very much in the economic interests of dairy companies to demonstrate the nutritional superiority of dairy products over plant-based alternatives.

Reference: For a summary of research on the “funding effect”—the observations that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests and that recipients of industry funding typically did not intend to be influenced and do not recognize the influence—see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

On July 19, I did a post on a recent study comparing the nutrient composition of plant-based meat alternatives to that of grass-fed beef.  I was not surprised that the study found nutritional differences; they are to be expected.

I was surprised that “From the abstract and conclusion, the study appears to suggest that meat is nutritionally better,” but the authors said the two types “could be viewed as complementary in terms of provided nutrients. It cannot be determined from our data if either source is healthier to consume.”   That confused me.  I also was confused by the authors’ reported conflicts of interest and said so.

One reader wrote to say that I was being unfair to the authors, who are excellent scientists.

Indeed, the authors followed up with an explanation, which I offered to post here without further comment.  They agreed to that.

Dear Dr. Nestle,

Many thanks for posting about our work. We have the utmost respect for your work and we have cited your work in our papers and books (e.g., Provenza’s Nourishment). You are an influential and well-respected person, and as you noted, your followers wanted you to inform them about this paper. When reading the post about our work, we were particularly surprised that you didn’t send us an email to fact-check your points, especially since we were introduced by email on 7/7 that noted: “I’ve copied two of the researchers involved Stephan van Vliet and Fred Provenza. That way if you have any further questions, you can pose those to the researchers directly.” If you disagree, c’est la vie, but at least that would have enabled you to write an informed critique, rather than one that is speculative and, at times, incorrect.

An off-hand and speculative statement such as this one: “maybe the vegetarian was responsible for the hedging comments?” would easily have been addressed by simply sending us an email inquiring about this. We would have gladly told you that it was three of the omnivores (SVV, FDP, SK) who were particularly concerned that people would over extrapolate the data. We were especially concerned that people would interpret our data as beef being “better”. That is not what the data indicate (more on what the data does indicate below). Hence our clear and repeated statement: “It cannot be determined from our data if either source is healthier to consume.”

We are writing you this friendly note to put some context to the points that you made. We hope that you will take them as our attempt to reinforce points that we were careful to develop so our paper was not one-sided.

“So, they’re framing everything with the baseline that animal meat is “proper nutrition” which seems like a pretty obvious bias right out of the gate…”

The two words you quoted are from a much more nuanced sentence, which reads: “This has raised questions of whether plant-based meat alternatives represent proper nutritional replacements to animal meat”. This statement refers to a number of papers by different research groups (see our paper for citations) who pose that very question, which we were interested in exploring. This is much more nuanced statement than what you suggest in the blogpost, which simply states animal meat is “proper nutrition”, which, to us, feels like a twisting of our carefully chosen words.

That we are not framing meat as “proper nutrition” is further illustrated by the stated goal of this work at the end of the introduction: “Given the scientific and commercial interest in plant-based meat alternatives, the goal of our study was to use untargeted metabolomics to provide an in-depth comparison of the metabolite profiles of grass-fed ground beef and a popular plant-based meat alternative, both of which are sometimes considered as healthier and more environmentally friendly sources of “beef”.

Furthermore, we also have to be realistic here and not dance around the obvious; the goal of plant-based meat alternatives is to provide a sensory and nutritional replacement for meat, as illustrated in press releases such as Impossible’s “We are Meat”. If one were to add carotenoids and fiber to a meat sausage (see Arby’s Marrot https://www.foodandwine.com/news/arbys-meat-carrots) and consider this a replacement to a carrot…. We would ask the same question: to what extent do a carrot and a meat-based carrot alternative differ nutritionally? It would be reasonable to take the carrot as the benchmark. All in all, we argue that our framing of the research question is much more nuanced than you suggested in your blogpost. “

To the question of nutritional differences, duh, indeed. Why would anyone not expect nutritional differences? From the abstract and conclusion, the study appears to suggest that meat is nutritionally better.”

As we acknowledge in the abstract “Important nutritional differences may exist between beef and novel plant-based alternatives; however, this has not been thoroughly assessed.” Please give us some credit. One of us (Fred Provenza) has studied plants and animals for over 50 years. Of course, we expected meat from a cow to differ from meat from soybeans, but the extent to which this may be the case had not been studied. Nor is this clear to the consumer who is simply looking at Nutrition Facts panels, another very important reason why we did the research. Another issue is that foods are often considered equivalent simply based on their protein content (even in dietary guidelines), but “protein foods” can be vastly different in terms of the non-protein nutrients they provide. We recommend Dr. Courtney-Martin’s editorial in AJCN titled “Is a peanut really an egg”. (https://academic.oup.com/jn/article/151/5/1055/6217441). She discusses these issues in such an elegant way.

We do not suggest that meat is nutritionally better, we clearly state the following in the abstract (something you cite in your blogpost): “Amongst identified metabolites were various nutrients (amino acids, phenols, vitamins, unsaturated fatty acids, and dipeptides) with potentially important physiological, anti-inflammatory, and/or immunomodulatory roles—many of which remained absent in the plant-based meat alternative when compared to beef and vice versa. Our data indicates that these products should not be viewed as nutritionally interchangeable, but could be viewed as complementary in terms of provided nutrients. It cannot be determined from our data if either source is healthier to consume.”

The italicized portions are key: we state that some nutrients are not found in the plant-based meat alternative and some nutrients are not found in the meat. Nothing more and nothing less. We also clearly state that we cannot determine from this metabolomics analysis if one is healthier than the other. We intend to pursue that question in research with people, but based on current research we also have to be realistic and we, therefore, highlight the following: “Further work is needed to inform these discussions; however, we consider it important to not lose sight of the “bigger picture” in these discussions, which is the overall dietary pattern in which individual foods are consumed. That is arguably the predominant factor dictating health outcomes to individual foods. Of note is a recent 8-week randomized controlled trial that found that a “flexitarian approach” (swapping moderate amounts of meat with novel plant-based alternatives as part of an omnivorous diet) may have positive benefits in terms of weight control and lipoprotein profiles (e.g., LDL-cholesterol).” (https://doi.org/10.1093/ajcn/nqaa203).

We are not particularly touting the superiority of meat in the discussion. We mention many of the potential health benefits of the compounds found in plant-based meat alternatives such as phytosterols, tocopherols, and other phenolic anti-oxidants, which were more abundant or exclusively found in the plant-based meat alternative.

“Really? If they can’t figure out which is better, why do this study?”

It is not a question of which one is better. It is about understanding potential similarities and differences. Is an almond better than an orange? That depends on the types of nutrients you are looking to get. If you want Vitamin C, an orange is preferred over an almond. If you want Vitamin E, consume the almonds. But there is also nutritional overlap, because both provide fiber and they have complementary phytonutrient profiles. A silly example perhaps when you put it like that, but that’s analogues to what we are stating in the paper.

“As for the conflicted interests: My first reaction to seeing this study was to ask: “Who paid for this?”

No funding was received for this work. The cost of the meat and plant-based meat alternatives (~$600) was paid with my [Dr. Stephan van Vliet] personal credit card (I am a post-doc and had no grant or start-up funds when I first arrived at Duke). The cost of metabolomics (~$200 per sample) was waived by Duke Molecular Physiology Institute’s Metabolomics Core. This was generously done to provide an early career investigator like myself to generate pilot data for a publication and grants.

The North Dakota Beef Association grant that I am the PI on [Dr. Stephan van Vliet] is $135k (not a very big grant) and supports a 4-week RCT that studies cardiovascular risk biomarkers and metabolome profiles in response to eating beef as part of a traditional (whole food) vs standard American diet. Various epidemiological studies suggest that when red meat is consumed as part of a whole foods diet, the associated risk with CVD becomes neutral, whereas eating red meat as part of a standard American diet is associated with increased disease risk. We are testing/falsifying this hypothesis prospectively in a short-term RCT and are exploring potential mechanisms by which this may or may not be the case. This work has nothing to do with plant-based meat alternatives.

The Turner Institute of Ecoagriculture ($27.5k) and the Dixon Foundation ($12.5k) are pilot grants to run metabolomics on grass-fed vs grain-fed bison and beef, respectively. The USDA-NIFA-SARE grant is collecting both plant (crops + fruit) and animal (eggs + beef) food samples from farms that use agroecological principles such as integrated crop-livestock systems. Here we are asking the question: How do practices that potentially stimulate soil health and plant diversity impact the healthfulness of animal and plant foods for human consumption? To be clear, we are also studying crop samples (soy, corn, and peas) some of which may go into alternative protein production.

My [Stephan van Vliet] conflict-of-interest policy is also essentially similar to yours: I accept funding for travel, hotels, meals, and meeting registrations, but I do not accept personal honoraria, consulting fees, or any other financial payments from such groups. A simple email could have cleared that up, but I will make sure that I state this more clearly in future papers.

Of course, we understand the public suspicion about research funding and undue influence. If a certain funding agency doesn’t like the data or the proposal and they don’t want to fund any of our projects then that is what it is, but we would not risk our reputation and career for a few research dollars or to please the funding agency. That’s why we are pushing back on this. Fred Provenza, especially, has been critical of the way beef is produced in confinement feeding operations (e.g., see recent paper https://doi.org/10.3389/fsufs.2021.547822), so the suggestion that we are beef industry defendants rather than independent scientists does sting a bit.

At the same time, we would also be lying if we didn’t think about where funding comes from. However, the harsh reality is that without foundation/commodity funds for scientific research, there would be much less research, much of which has also proven valuable over time. Even with our USDA grant, one could argue that the reason we are funded is because we wrote a good proposal, but also because our proposed work can presumably benefit the US Farm Bill. Is that true independence? All we know is that we should be transparent (hence our detailed competing interest statement) and let the data speak for itself (hence we attached our full data set as supplementary materials and deposited raw data files on metabolomics workbench), which is what we aimed to do in our Sci Rep paper.

We appreciate your concerns. We will certainly take these into account as we move forward and continue to be critical of our work. We hope you also consider our concerns and are willing to keep an open and friendly dialogue.

Sincerely,

Stephan van Vliet

Fred Provenza

Scott Kronberg