Currently browsing posts about: Sponsored-research

Thanks to Lisa Young for sending this announcement: New Research Examines Blueberries’ Positive Impact in Men with Type 2 Diabetes. 

I am already on record as saying that I love blueberries, but I wish they weren’t marketed as superfoods.  All fruits, vegetables, nuts, and grains provide nutrients and fiber.  That makes all of them worth eating for their nutrition-and-health value as well as their taste.  Singling out one or another makes no sense to me, but I’m not in the business of selling one rather than another.  Because similar results would be expected from studies of many other fruits, I put this one in the category of marketing research.

Effect of Blueberry Consumption on Cardiometabolic Health Parameters in Men with Type 2 Diabetes: An 8-Week, Double-Blind, Randomized, Placebo-Controlled Trial.  Kim S Stote, Margaret M Wilson, Deborah Hallenbeck, Krista Thomas, Joanne M Rourke, Marva I Sweeney, Katherine T Gottschall-Pass, Aidar R Gosmanov.  Current Developments in Nutrition, Volume 4, Issue 4, April 2020, nzaa030. 

Conclusion: “Consumption of 22 g freeze-dried blueberries for 8 wk may beneficially affect cardiometabolic health parameters in men with type 2 diabetes.”

Funding:  “Supported by the US Highbush Blueberry Council (to KSS, MMW, and ARG) and by resources and the use of facilities at the Stratton VA Medical Center, Albany, NY, USA.  Author disclosures: KSS, MMW, and ARG received intervention products from the US Highbush Blueberry Council. All other authors report no conflicts of interest.  The US Highbush Blueberry Council supplied the funds to conduct the study but was not involved in the design, implementation, analysis, or interpretation of data.

Comment:  The funder does not have to be involved.  Everyone knows funders are not interested in funding research that might produce results unfavorable to their product.  Freeze-dried blueberries sound like medicine.  I’d rather eat the real things.

If you are a marketer of fruit juice, you have a problem.  Fruit juice has a lot of sugar and retains little of the fiber of whole fruit.  Dietary recommendations increasingly suggest limits on the amounts consumed, especially for children.

But according to the trade group, the Juice Products Association, “The 2015 Dietary Guidelines for Americans and the American Academy of Pediatrics (AAP) concur that 4 to 6 ounces of 100% fruit juice per day is appropriate for young children. For children age 7 and older, the AAP recommends a daily serving of 8 to 12 ounces per day.”

No it does not!  The American Academy of Pediatrics suggests a limit to that amount.  Big difference.

Juice should not be introduced into the diet of infants before 12 months of age unless clinically indicated. The intake of juice should be limited to, at most, 4 ounces/day in toddlers 1 through 3 years of age, and 4 to 6  ounces/day for children 4 through 6 years of age. For children 7 to 18 years of age, juice intake should be limited to 8 ounces or 1 cup of the recommended 2 to 2.5 cups of fruit servings per day.

What about adults?  Adults do not need more sugars or the calories they provide.   They too would be better off eating fruit.

Juice trade associations to the rescue.

The study:  100% Fruit juice intake and cardiovascular risk: a systematic review and meta-analysis of prospective and randomised controlled studies. Lanfranco D’Elia, et al.  European Journal of Nutrition (2020)

Methods: This is a meta-analysis of prospective studies and randomized controlled trials (RCTs) examining the relationship between consumption of 100% fruit juice (FJ) and the risk of cardiovascular disease (CV).

Conclusions: “The results of these analyses indicate that 100%FJ consumption is not associated with higher CV risk. A non-linear inverse dose–response relationship occurs between 100%FJ consumption and CV disease, in particular for risk of stroke, probably mediated by the decrease in blood pressure.”

Funding: “Open access funding provided by Università degli Studi di Napoli Federico II within the CRUI-CARE Agreement. This project was funded by the European Fruit Juice Association (AIJN) via an unrestricted grant. AIJN was not involved in the design, conduction, analysis and interpretation of the results.”

Comment: Why would anyone think that fruit juice, of all things, would be associated with heart disease risk?  You would have to be drinking a lot of it —at the exclusion of healthier foods—for it to make  a significant difference.  The only point of this study is to try to convince adults to drink more juice.  When I was a kid, fruit juice was expensive and we drank it in 4-ounce glasses.  If you drink fruit juice at all, that’s still a good idea.

Even after writing Unsavory Truth: How the Food Industry Skews the Science of What We Eat I could hardly believe this particular example.

The Study: Exploring the Influence of Alcohol Industry Funding in Observational Studies on Moderate Alcohol Consumption and Health.   Moniek Vos, Annick P M van Soest, Tim van Wingerden, Marion L Janse, Rick M Dijk, Rutger J Brouwer, Iris de Koning, Edith J M Feskens, Aafje Sierksma.  Advances in Nutrition, Volume 11, Issue 5, September 2020, Pages 1384–1391.

Methods:  This is a meta-analysis of meta-analyses of studies examining the health effects of alcohol consumption that are used as the basis of international guidelines for alcohol consumption.

Results and conclusions: “only a small proportion of observational studies in meta-analyses …are funded by the alcohol industry. Based on this selection of observational studies the association between moderate alcohol consumption and different health outcomes does not seem to be related to funding source.

Funding: “The authors reported no funding received for this study.”

Author disclosures: “MV, APMvS, TvW, MLJ, RMD, RJB, IdK, and AS were employed by the Dutch Beer Institute during the study and writing of the manuscript. This Institute is funded by Dutch Brewers, which is the trade organization of the 14 largest beer brewers in the Netherlands. EJMF reports no conflicts of interest.”

Comment: This one defies credulity: an industry-funded study—most authors work for the beer industry—of whether industry funding affects research outcome.

Guess what?  It didn’t find any effect.

For years, the alcohol industry has been working hard to convince regulators and the public that moderate drinking, especially of wine and beer, is not only harmless but actually improves health.  This study is an example of how this industry attempts to accomplish that goal.

For another egregious example, see this post.

The potato industry has a problem.  Some nutrition experts do not recommend them and argue that potatoes—especially French fries—raise blood sugar levels and should be excluded from recommendations to increase vegetable intake (I love potatoes in any form but try not to overeat them—everything in moderation if you can manage that, and I can).

In any case, the The Alliance for Potato Research & Education (APRE) is devoted to protecting the reputation—and sales–of potatoes, and funds research for that purpose.

The study: Daily intake of non-fried potato does not affect markers of glycaemia and is associated with better diet quality compared with refined grains: a randomised,crossover study in healthy adults.   EA Johnston et al.  British Journal of Nutrition (2020), 123, 1032–1042.

Results: “Compared with refined grains, the HEI-2015 Healthy Eating Index] scores..were higher following the potato condition. Consuming non-fried potatoes resulted in higher diet quality, K  [potassium] and fibre intake, without adversely affecting cardiometabolic risk.”

Financial Support: The Alliance for Potato Research and Education provided funds for the research conducted. Their staff were not involved in any aspects of conducting the study, analyzing the data or interpreting the results presented.

Comment: The APRE says it remains firmly committed to the scientific integrity of industry-funded research”  Its guidelines for research integrity sound good, but don’t address the inherent problems of industry-funded research: the well established “funding effect” that virtually guarantees that industry-funded research will produce results that favor the sponsor’s interests, and the also well established observation that investigator bias tends to occur at an unconscious level.  The exclusion of fried potatoes from this particular study suggests that the investigators know that frequent eating of French fries is a marker of poor diet quality.  I think potatoes have a place in healthy diets and that much depends on their particular role and preparation.  As with much in nutrition, the potato situation is complicated, and industry funding does not help with clarification.

When I saw the title of this study, I had two questions:

• Why would anyone do a study like this? (OK, in short-term studies, consuming water or soup before meals reduces immediate calorie consumption, but in the long term?)
• Who paid for it?  (Getting the answer to this one took some digging).

The study: Association between soup consumption and obesity: A systematic review with meta-analysis. M.Kuroda and K. Ninomiya. Physiology & Behavior,  Volume 225, 15 October 2020, 113103.

Conclusion: “soup consumption is significantly related to lower odds ratio of obesity…suggesting that soup consumption was inversely correlated with a risk of obesity.”

Marta Zaraska, the author of Meathooked: The History and Science of Our 2.5-Million-Year Obsession With Meat and, more recently, Growing Young: How Friendship, Optimism and Kindness Can Help You Live to 100, sent me this message:

While doing research on my 3rd book I stumbled upon a research paper in which the authors “forgot” to disclose connections to the meat industry. I thought this may be interesting to you. Here is a link to the paper – https://www.tandfonline.com/doi/full/10.1080/10408398.2020.1741505

And here is a link proving that the lead author is taking money from the meat industry – which was not disclosed in the paper: https://www.usi.edu/liberal-arts/focus-newsletter/liberal-arts-achievements/la-achievements-2018-2019/

I thought this was well worth a look.  The full paper is here.

Title: “Meat and mental health: a systematic review of meat abstention and depression, anxiety, and related phenomena.”  Dobersek U, et al.  Critical Reviews in Food Science and Nutrition, 2020, published ahead of print.

Method: This is an meta-analysis of previously published papers (18) that compared the psychologica health of meat consumers and meat abstainers.

Conclusion: “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…Our study does not support meat avoidance as a strategy to benefit psychological health.”

When I saw this conclusion, I immediately wondered: “Who paid for this?”  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 sponsor of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report [for an interpretation of this last statement, see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat].

What got Marta Zaraska’s attention was the denial of conflicted interests related to this paper.

Disclosure: “No potential conflict of interest was reported by the author(s).”

But the University of Southern Indiana praises the 2018-2019 accomplishments of the first author of this paper as follows (my emphasis):

Dr. Urska Dobersek, assistant professor of Psychology, and her students presented their research, “Are levels of testosterone, willingness to cheat and exercise motives related?” and “The relationship between facial asymmetry and exercise” at the North American Society for the Psychology of Sport and Physical Activity national conference in Baltimore, Maryland.

Dobersek also received a $10,555 grant from the National Cattlemen’s Beef Association to conduct a systematic review on “Beef for a Happier and Healthier Life.“

Oops.  Omission of this grant gives the appearance of conflicted interest and should have been disclosed.  I hope the author corrects this oversight immediately.

If the other authors have similar connections to meat industry group, they too should disclose them.

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:

• Eating red meat increases TMAO levels. Should we care?
• TMAO — Smoking gun or passive observer?

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.

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.