by Marion Nestle

Currently browsing posts about: Sponsored-research

Aug 17 2020

Industry-funded study of the week: Beyond Meat

Stanford University issued a press release to announce the results of a study comparing physiological effects of eating plant-based meat alternatives (Beyond Meat) to eating foods of animal origin.

A diet that includes an average of two servings of plant-based meat alternatives lowers some cardiovascular risk factors compared with a diet that instead includes the same amount of animal meat, Stanford Medicine scientists found.

The study:  A randomized crossover trial on the effect of plant-based compared with animal-based meat on trimethylamine-N-oxide and cardiovascular disease risk factors in generally healthy adults: Study With Appetizing Plantfood—Meat Eating Alternative Trial (SWAP-MEAT).  Crimarco A, et al.  American Journal of Clinical Nutrition, August 11, 2020.  https://doi.org/10.1093/ajcn/nqaa203

Overall conclusion: “This study found several beneficial effects and no adverse effects from the consumption of plant-based meats.”

The sponsor: “Supported by a research gift from Beyond Meat Inc. (to CDG)…Funding for this study was provided by Beyond Meat. In an effort to reduce any influences on the outcomes of this study, a statistical analysis plan was submitted to ct.gov. The main analysis was conducted by a third-party individual who had no involvement with the study design or collection of data, and was blinded to all study participants.

Comment

Ordinarily, I would simply present this study as a classic example of how industry-funded studies predictably produce results that favor the commercial interests of their sponsors, a topic to which I devoted my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

But CDG is Christopher Gardner, the study’s lead scientist, whose impressive track record of managing complicated clinical trials of diet and health I greatly admire.

Gardner describes himself as a vegan (meaning that he eats no animal products).

Knowing of my concerns about industry-funded research, he wrote me some months ago to say that this study was in the works and to point out that he has done at least six industry-funded studies with null findings (he sent me a PowerPoint slide deck to prove it).  In his correspondence, he said:

  • “I believe this is the FIRST industry funded study I’ve run that had a significant positive health finding.”
  • “Beyond Meat was not involved in design or analysis, and to this day still doesn’t know the study outcome.”
  • “I’m preparing myself for being called out as a vegan industry shill….hoping I’ve established a reputation for objectivity to withstand this ?”
  • “PS – Hope you enjoy the study acronym (Study With Alternative Plantfood – Meat Eating Alternative Trial: SWAP-MEAT)” [Indeed I do].

OK.  So let’s take this study on its merits.

Gardner asked healthy non-vegetarian adults (36) to consume 2 servings a day of either Beyond Meat or regular meat (what the study calls Animal Meat).  The Beyond Meat and Animal Meat were provided to participants.  The rest of their diets was on their own.

For 8 weeks, they ate Beyond Meat or Animal Meat.  For the next 8 weeks, they switched over to the other kind.

Results: Participants consuming Beyond Meat displayed lower levels of

  • LDL-cholesterol (the bad kind)
  • Body weight (by 1 or 2 pounds)
  • TMAO (Trimethylamine N-oxide)—but only for those who consumed Animal Meat first and Beyond Meat second (not the other way around)

Beyond Meat may be plant-based, but it is ultraprocessed.  FoodNavigator produced a nice comparison.

Beyond Meat would dearly love to demonstrate that its ultraprocessed composition is immaterial to its health benefits.  Hence: this study.

Beyond Meat is already using it for marketing purposes: “New study finds health benefits of plant-based meats.”

As I see it, there are two issues here: (a) what else the participants were eating and (b) the significance of the TMAO measurements.

(a) The diet: This was not a controlled dietary intake trial conducted in a closed metabolic ward.  Participants were free to eat whatever they liked and how much they liked.  They lost a little weight during the Beyond Meat phase, which means they must have been eating fewer calories during that phase, as they reported (this graph is in the Supplementary material).

Reported daily calories were under 2000, which means that lots of calories must not have been reported.  So it’s hard to know what the weight loss is actually due to.

(b)  TMAO: You make TMAO after you eat foods containing choline, a compound common in animal-based foods: meat, poultry, fish, and eggs.  A 2019 editorial review in JAMA discusses the association of TMAO with heart disease risk.

Now, researchers are homing in on another possible culprit: a dietary metabolite linked to red meat called trimethylamine N-oxide, or TMAO. Three recent meta-analyses confirmed that high blood levels of TMAO are associated with increased risks of cardiovascular disease and all-cause mortality. One of the studies, published in the Journal of the American Heart Association in 2017, found a more than 60% heightened risk of both major adverse cardiovascular events and death from all causes in people with elevated TMAO. Other research has associated higher TMAO levels with heart failure and chronic kidney disease.

On the other hand, an analysis by Dr. Bret Scher raises questions about whether TMAO has any real meaning for health (and I thank Stephen Zwick for sending this to me).

In my opinion, this is an example of a well-run study that, in the end, lends very little to our knowledge of human health….The main outcome from this intervention had to do with TMAO. Why is this problematic? Well, it has to do with the fact that small, short-term trials are unable to measure meaningful endpoints, such as who lives, dies, or who gets heart disease.  So, instead, the authors have to choose the surrogate outcome markers that they believe relate to human health.

Dr. Scher believes that “There is no convincing evidence that these results impact someone’s health.”  As Scher has discussed previously, he sees no cause-and-effect relationship between TMAO levels and health.  You can read his arguments here:

The bottom line?  This study suggests that two servings a day of Beyond Meat is unlikely to be harmful.  Whether substituting Beyond Meat for real meat is truly useful for health in the absence of other dietary changes remains to be confirmed, hopefully by independently funded research.

Jun 29 2020

Industry-funded research, Australia style

A reader in Australia writes that she “just came upon a doozy of an industry-funded paper.”

Title: Sales of Sugar-Sweetened Beverages in Australia: A Trend Analysis from 1997 to 2018, by William S. Shrapnel and Belinda E. Butcher.  Nutrients 2020, 12, 1016; doi:10.3390/nu12041016.

Conclusion: Major, long-term shifts are occurring in the market for non-alcoholic, water-based beverages in Australia, notably a fall in per capita volume sales of SSBs and an increase in volume sales of water. Both trends are consistent with public health nutrition strategies for obesity prevention and suggest that the downward trend in the percentage of dietary energy from added sugars in the Australian diet may be continuing.

Funding and Conflicts of Interest: This analysis was funded by an unrestricted grant from The Australian Beverages Council Ltd. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

So what’s the problem here (besides the usual questions about the accuracy of the “no role” statement)?

The clue comes from an article in Food Navigator Asia: “Not a taxing question: Australian sugar sweetened beverage consumption slumps as obesity rates continue to soar.”

The article quotes a representative of the Beverage Council:

Obesity is multi-factorial, the reason why people become overweight and then obese, is because of the lack of physical activity, a sedentary lifestyle, and also poor diet…a sugar tax alone would not reduce the obesity rates in the country, and was a complex challenge for the government to overcome.  The beverage industry is against a sugar tax, and SSB tax.  The evidence and science behind the effectiveness of a sugar tax is weak.

Comment: The point of this study is to produce evidence against the value of soda or sugar taxes, even though sodas are still the largest source of sugars in Australian diets, and taxes have been shown to reduce consumption in other countries.  When it comes to sugary drinks, less is better.

Just for fun, here’s Healthy Food America’s 2019 map of countries with soda taxes.

 

May 18 2020

Industry-funded study of the week: Avoiding meat makes you depressed, anxious, suicidal?

In this Coronavirus era, anything that helps keep you sane is worth trying.

That’s why I loved this headline: “Meat eaters have better mental health than vegans and vegetarians, study claims.”

I couldn’t wait to see this one.

The study: Dobersek U, et al.  Meat and mental health: a systematic review of meat abstention and depression, anxiety, and related phenomena, Critical Reviews in Food Science and Nutrition, 2020.

The majority of studies, and especially the higher quality studies, showed that those who avoided meat consumption had significantly higher rates or risk of depression, anxiety, and/or self-harm behaviors. There was mixed evidence for temporal relations, but study designs and a lack of rigor precluded inferences of causal relations. Our study does not support meat avoidance as a strategy to benefit psychological health.

Seeing a title and conclusions like these, I couldn’t help but wonder who funded it.  Bingo!

Funding: This study was funded in part via an unrestricted research grant from the Beef Checkoff, through the National Cattlemen’s Beef Association.

The funding statement then continues with “The sponsor of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report.”  The disclosure statement says: “No potential conflict of interest was reported by the author(s).”

Comment: It’s too bad for the credibility of these statements that so much research demonstrates a strong influence of industry funding on research conclusions, and that much of the influence occurs unconsciously; researchers don’t recognize the influence.  The basic observation: industry-funded research almost invariably favors the sponsor’s interests.

The meat industry is under intense scrutiny these days for its treatment of animals and slaughterhouse workers—the topics of my next posts.  Stay tuned.

Thanks to Daniel Skaven Ruben for being the first to write me about this study.

Apr 2 2020

Tone deaf industry-funded study of the week: avocados and cognition

I don’t know about you but I’m having a hard time these days paying attention to anything other than Coronavirus.  Everything else seems irrelevant.

This announcement seems particularly tone deaf.

On March 18, the USDA’s National Institute of Food and Agriculture put this as its most important story of the day: “Daily Avocado Consumption Improves Attention in Overweight and Obese Persons

It refers to a study jointly funded by USDA and Haas Avocado Board: “Effects of 12-week avocado consumption on cognitive function among adults with overweight and obesity.”  Edwards CG, et al.  International Journal of Psychophysiology.  2020;148:13-24.

The study’s predictable conclusion: “Daily avocado intake over 12 weeks, after controlling for covariates, improved attentional inhibition and increased serum lutein concentrations among adults with overweight and obesity.”  This was predictable because industry-funded studies almost invariably come out the way their funder hoped they would (what a coincidence!).

In this case, the Abstract goes on to say: “However, the cognitive benefits were independent of changes in lutein concentrations.”

Really?  If lutein has nothing to do with cognition, why make such a big deal of it, as is done on the Hass Avocado Board website.

Don’t get me wrong.  I love avocados.  But I will never understand why it takes this kind of “science” to sell them.  I put science in quotes because this kind of industry-funded research is really about marketing.  USDA co-sponsors such research through its marketing programs.

This kind of self-serving marketing seems even more inappropriate right now.  At least to me.

[Thanks to Hugh Joseph for sending the NIFA annoouncement].

Mar 16 2020

Industry funded study of the week: the benefits of infant formula

The study:  Influence of a Functional Nutrients-Enriched Infant Formula on Language Development in Healthy Children at Four Years Old.  Ana Nieto-Ruiz, et al.  Nutrients 202012(2), 535; https://doi.org/10.3390/nu12020535

Conclusion: “The functional compound-enriched infant formula seems to be associated with beneficial long-term effects in the development of child’s language at four years old in a similar way to breastfed infants.”

Funding: “This project has been funded by Ordesa Laboratories, S.L.” Ordesa Laboratories, you will not be surprised to know, makes infant formula products.

Comment:  Infant formula companies have a problem: the products are virtually identical in nutrient composition (they all have to meet the same nutritional standards), babies only need them for the first year at most, and the number of babies is finite.  From the formula industry’s perspective, the challenge is how to increase sales.  This study shows that formula works pretty much as well as breast milk, no surprise.
But it got press attention: “Nutrient-enriched infant formula appears beneficial for kid’s language development, study finds.”

Mar 9 2020

Industry-funded study of the week: fruit extracts and cognitive function

I learned about this one from Nutra-Ingredients-latam.com, one of those industry newsletters I avidly follow: “Grapes plus blueberries may boost cognitive function in college students.”

The study: Acute Intake of a Grape and Blueberry Polyphenol-Rich Extract Ameliorates Cognitive Performance in Healthy Young Adults During a Sustained Cognitive Effort.  Philip P, et al.  Antioxidants 2019, 8, 650; doi:10.3390/antiox8120650.

Purpose: “This study investigated the acute and sustained action of a polyphenols-rich extract from grape and
blueberry (PEGB), on working memory and attention in healthy students during a prolonged and intensive cognitive effort.”

The comparison: “Participants were asked to either consume 600 mg of polyphenol-rich active extract made from
grape (Vitis vinifera L.) and wild blueberry (Vaccinium angustifolium) (Memophenol, Activ’Inside, Beychac et Caillau, France), or a placebo containing pure maltodextrin (Maltrin® M100, Roquette, Lestrem, France) and providing no polyphenol.”

Conclusion: “Our findings suggest that consumption of PEGB coupled with a healthy lifestyle may be a safe alternative to acutely improve working memory and attention during a sustained cognitive effort.”

Funding: This study was funded by Activ’Inside (Bordeaux area, France).

Comment: All I had to do was see the title of this study to guess that it was funded by a company with a vested interest in the study’s outcome.  Activ’Inside makes antioxidant extracts for purposes like this.  I’m all for college students eating grapes and blueberries rather than taking drugs to keep them up all night, but flavanol extracts?  Not the same.  Chalk this one up to marketing, not science.

Mar 2 2020

Industry-funded reviews of the week: dairy foods

The dairy industry, ever under siege, is doing its best to convince us to eat dairy foods.  Full disclosure: I eat and like dairy foods.  I do not, however, like the way the dairy industry funds research aimed at marketing its products.  Here are two examples.

Example 1: Full-fat dairy foods are good for you [yes, they can be, but in moderation]

The study: Potential Cardiometabolic Health Benefits of Full-Fat Dairy: The Evidence Base.  Kristin M Hirahatake, Arne Astrup, James O Hill, Joanne L Slavin, David B Allison, and Kevin C Maki.  Adv Nutr 2020;00:1–15.

Conclusions: “Emerging evidence shows that the consumption of full-fat dairy foods has a neutral or inverse association with adverse cardiometabolic health outcomes, including atherosclerotic cardiovascular disease, type 2 diabetes, and associated risk factors.”

Conflicts of interest and funding (dairy groups are highlighted):

Example 2: Dairy foods can help reduce world hunger [of course they can]

The report: Dairy’s Impact on Reducing Global Hunger

Major finding: “The remarkable consistency of the positive association between dairy animal ownership,
milk/dairy intake, and child growth across the experimental and observational studies, and
the dose-response relationship between dairy consumption and child growth…provide strong evidence that, in rural
low-income settings, household milk production increases household milk consumption, and increased milk consumption results in improved child growth and reduced stunting.”

Recommendation: “dairy development needs to be accompanied by nutrition education of caregivers to ensure that milk is provided in the most critical phase of childhood, namely in the 0.5 to 2-year age group”

Sponsors: “Published by Food and Agriculture Organization of the United Nations, Global Dairy Platform and
IFCN Dairy Research Network.

Comment:  It’s interesting to compare the first paper to another one done by investigators who are not funded by the dairy industry.  They don’t disagree, exactly, but spin the results much less favoably.  See: Milk and Health, by Walter C. Willett and David S. Ludwig. N Engl J Med 2020;382:644-54.

…guidelines for milk and equivalent dairy foods ideally should designate an acceptable intake (such as 0 to 2 servings per day for adults), deemphasize reduced-fat milk as preferable to whole milk, and discourage consumption of sugar-sweetened dairy foods in populations with high rates of overweight and
obesity.

Dairy foods are foods.  Like any other, they are not essential.  If you like them, eat them—in moderation, of course.

Feb 24 2020

Industry-funded study of the week: collagen supplements

The study: A Collagen Supplement Improves Skin Hydration, Elasticity, Roughness, and Density: Results of a Randomized, Placebo-Controlled, Blind StudyNutrients 201911(10), 2494.

Purpose: “The purpose of this randomized, placebo-controlled, blind study was to investigate the effects of the drinkable nutraceutical ELASTEN® (QUIRIS Healthcare, Gütersloh, Germany) on skin aging and skin health.”

Conclusions: The test product significantly improved skin hydration, elasticity, roughness, and density…These positive effects were substantially retained during the follow-up.

Funding: This research was funded by Quiris Healthcare, Germany.

Conflicts of Interest: The authors declare no conflict of interest. The sponsor had no influence on execution, analysis and interpretation of the data.

Comment: The funder, Quiris Healthcare, “develops and sells innovative, natural health products. The focus is on effectiveness and special quality.”  What struck me about this particular example is how the authors report no conflict of interest and state that the sponsor had no influence on how the study was conducted, analyzed, and interpreted.  Most research on the influence of industry funding indicates that it most often shows up in the study design.  Research also shows that investigators are unaware of the influence; it occurs at an unconscious level.  I review data backing up these statements in my book Unsavory Truth: How Food Companies Skew the Science of What We Eat.