Currently browsing posts about: Sponsored-research

My thanks to Paola Baratto for sending this one.

The study: . Intakes of Added Sugars, with a Focus on Beverages and the Associations with Micronutrient Adequacy in US Children, Adolescents, and Teens (NHANES 2003–2018).  Ricciuto L, Fulgoni VL III, Gaine PC, Scott MO, DiFrancesco L.   Nutrients. 2023; 15(15):3285. https://doi.org/10.3390/nu15153285.

Method: This is an analysis of links between added sugars from different kinds of drinks and nutrient adequacy in children using combined data from 8 consecutive NHANES surveys (2003-2018).

Results: I found the results hard to understand because they are presented selectively by age, and they compare nutrient intakes to estimated average requirements.  Here is what I think they mean:

• 2 to 8 year olds: If they got their sugar from flavored milk, they had better calcium intake.
• 9 to 18 year olds: If they got their sugar from soft drinks, coffee, or tea, thei had worse intakes of magnesium and vitamins A and C.  But if they got their sugars from fruit drinks or flavored milk, they had better intake of vitamin C (from the fruit drinks), and of calcium, magnesium, phosphorus, vitamin A, and potassium (from the flavored milk).
• 9 to 18 year olds: Higher intake of added sugars in the overall diet was associated with bettter intake of vitamins and minerals.

Conclusion: The results suggest that the relationship between added sugars intake and micronutrient adequacy depends on the added sugar sources and their nutrient composition.

Funding: The funding for this research was provided by The Sugar Association, Inc. P.C.G. and M.O.S. are employed by The Sugar Association Inc., had input in the study design, and reviewed and edited the manuscript.

Comment: The Sugar Association’s purpose in sponsoring this study is to buttress its argument that sugary drinks and foods have nutrients and, therefore, do not warrant restrictions.  If you get the idea from this study that the more sugary foods you eat, the more nutrients you and your kids get, the Association will be even happier.  Sorry Sugar Association, but it is quite possible to consume adequate intakes of vitamins and minerals without eating sugary foods and doing so will make calories easier to control.  With this study, the Sugar Association got what it paid for.

Thanks to Matthew Kadey for sending this one.  Matcha is a new one for me.

The study: Matcha green tea beverage moderates fatigue and supports resistance training-induced adaptation.  Shigeta M, et al.  Nutrition Journal volume 22, Article number: 32 (2023)

Methods: Healthy, untrained men were randomized into placebo and matcha groups. Participants consumed either a matcha beverage containing 1.5 g of matcha green tea powder or a placebo beverage twice a day and engaged in resistance training programs for 8 (trial 1) or 12 weeks (trial 2).

I posted several examples of industry-funded studies this week in part to reduce my backlog but also because of charges that (1) doing so constitites ad hominem (personal) attacks on authors, (2) I should be focusing on the science, not who paid for it, and (3) I have my own ideological biases.

To the first point:

I do not see industry funding of research as a personal matter.  I see it as a systematic problem.

If I see a study titled “Effect of food product X on disease Y,” I can often guess that

• The food’s manufacturer or trade association paid for it
• The study outcome will be favorable to the funder’s commercial interests

This phenomenon is so systematic that it has a name: The Funding Effect.

To the second point

Researchers who study funding effects, and there are many, note that the scientific conduct of the studies is not usually an issue.  Instead, the influence of the funders shows up in the way the research question is framed or the results are interpreted.

The easiest way to explain the research question bias is to cite the requests for research proposals I often receive from food trade associations.  These say: “we have (this much money) for research to demonstrate the benefits of our product on (one or more of these conditions).”

These groups will not fund research proposals unlikely to show benefits.

As for interpretation, industry-funded studies tend to report null results as positive; I posted several such examples this week.

To the third point

Yes, I have ideological or opinion biases and I try to be as clear as I can about them.  All investigators have such biases; otherwise they wouldn’t be doing science.  We all have something we believe in that we would like to prove.  Such biases are not discretionary; everyone has them.  In contrast, industry funding is about selling products, not science and is completely discretionary; investigators can do science without it.

The evidence?

I review the evidence for what I’ve just said here in my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

In it, I cite many other books and papers addressing these points.

We all come to the same conclusions:

• Industry funding biases research.  But funded investigators do not recognize the influence, and deny it.
• The statement that accompanies many disclosure statements—“The funder had no influence on the design, conduct, interpretation, or publication of the results,”—is often untrue and must be taken with some degree of skepticism.

I see industry funding of food and nutrition research as a serious problem for public perception.  Even when the research is not conflicted, it appears conflicted.  That alone is a systematic problem.

Nuts are demonstrably good for health.  They have high proportions of fat and, therefore, calories, and the calories can add up quickly.  But a small handful makes a great healthy snack.

Why their trade associations feel they need to produce favorable research is beyond me, but as far as I can tell, they are all competing with each other for market share.

Here are a few examples of nut studies funded by trade associations to convince you to eat more nuts.

The point: Whenever you see a study showing amazing health benefits from one single food, there’s a good chance its trade association paid for it.

NUTS IN GENERAL

The study: Mixed Tree Nuts, Cognition, and Gut Microbiota: A 4-Week, Placebo-Controlled, Randomized Crossover Trial in Healthy Nonelderly Adults.  J. Nutrition.   VOLUME 152, ISSUE 12, P2778-2788, DECEMBER 2022.  DOI:https://doi.org/10.1093/jn/nxac228

Conclusions: These findings indicate a positive effect of nut on cognition following only 4 wk of consumption in a healthy nonelderly sample, as well as upregulation of a microbial taxa associated with gut health. The effects appear to be independent of one another, but further exploration is required in those experiencing cognitive decline and/or gut dysbiosis.

Funding: This study was supported by funding from the INC (International Nut and Dried Fruit Council).

ALMONDS

The study: Almond intake alters the acute plasma dihydroxy-octadecenoic acid (DiHOME) response to eccentric exercise.  Front. Nutr., 09 January 2023. Volume 9 – 2022 | https://doi.org/10.3389/fnut.2022.1042719.

Conclusions: In general, the elevated post-exercise plasma levels of 12,13-DiHOME with almond intake support positive metabolic outcomes for adults engaging in unaccustomed eccentric exercise bouts. Other almond-related benefits for exercisers revealed in this study include reduced feelings of fatigue and tension, better leg-back strength during recovery, and decreased muscle damage during the first day of recovery.

Funding: This work was supported by Almond Board of California, Modesto, CA. The funder had no role in the study design, data collection, analysis and interpretation, the preparation of the manuscript, or in the decision to submit the article for publication.

MACADAMIAS

The study: Macadamia nut effects on cardiometabolic risk factors: a randomised trial  J Nutr Sci. 2023.

Conclusion: Daily consumption of macadamia nuts does not lead to gains in weight or body fat under free-living conditions in overweight or obese adults; non-significant cholesterol lowering occurred without altering saturated fat intake of similar magnitude to cholesterol lowering seen with other nuts.

Funding: This study was funded by Hort Innovation, Sydney, Australia (Project code MC17005).  J. J., K. O. and F. M. – None; J. S., S. R. and C. H. have received research funding through their institution from Hort Innovation, Sydney, Australia.  Note: Hort Innovation is a grower-owned, not-for-profit research and development corporation with the goal of creating value for horticulture growers and those across the horticulture supply chain. It invests more than $120 million in R&D, marketing and trade programs on behalf of industry.

PEANUTS

The study:  Urinary Phenolic Metabolites Associated with Peanut Consumption May Have a Beneficial Impact on Vascular Health Biomarkers. Antioxidants. 2023; 12(3):698. https://doi.org/10.3390/antiox12030698.

Conclusion:  the present study shows for the first time that regular peanut and peanut butter consumption could have a positive impact on vascular biomarkers in healthy young adults.

Funding: This research was supported by funding from the Peanut Institute

Thanks to Arjan van Groningen for this one.

The study:  The Effect of Non-Nutritive Sweetened Beverages on Postprandial Glycemic and Endocrine Responses: A Systematic Review and Network Meta-analysis. Zhang, R.; Noronha, J.C.; Khan, T.A.; McGlynn, N.; Back, S.; Grant, S.M.; Kendall, C.W.C.; Sievenpiper, J.L. Nutrients 2023, 15, 1050. https://doi.org/10.3390/nu15041050.

Conclusions: The available evidence suggests that NNS beverages sweetened with single or blends of NNS have no acute metabolic and endocrine effects, similar to water. These findings provide support for NNS beverages as an alternative replacement strategy for SSBs in the acute postprandial setting.

Funding: This work was supported by an unrestricted grant from the Institute for the Advancement of Food and Nutrition Sciences (IAFNS). The grant was awarded through a competitive request for the proposal process. The sponsor was not involved in the development of the study protocol and design, execution, analyses, interpretation of the data, or decision to publish. The protocol and results were presented to the Low- And No-Calorie Sweeteners Scientific Committee of IAFNS on several occasions with an opportunity for scientific dialogue.

Comment:  IAFNS is the new name for ILSI North America, a classic industry front group.  To its credit, the authors disclose the involvement of IAFNS in this review.  Check out the Conflict-of-Interest declarations from this group; they are legendary.

Conflicts of Interest: J.C.N. has worked as a clinical research coordinator at INQUIS Clinical Research. He has also received research support from Glycemia Consulting Inc. T.A.K. has received research support from the Canadian Institutes of Health Research (CIHR), the International Life Science Institute (ILSI), and the National Honey Board. He has taken honorariums for lectures from the International Food Information Council (IFIC) and the Institute for the Advancement of Food and Nutrition Sciences (IAFNS; formerly ILSI North America). He is funded by the National Honey Board. N.M., was a former employee of Loblaw Companies Limited, and is a current employee of Enhanced Medical Nutrition. She has completed consulting work for contract research organizations, restaurants, start-ups, the International Food Information Council, and the American Beverage Association, all of which occurred outside of the submitted work. S.M.G. has received honoraria from Dietitians of Canada and Diabetes Canada for the development and delivery of educational resources on the glycemic index in the past five years. C.W.C.K has received grants or research support from the Advanced Food Materials Network, Agriculture and Agri-Foods Canada (AAFC), the Almond Board of California, Barilla, the Canadian Institutes of Health Research (CIHR), the Canola Council of Canada, the International Nut and Dried Fruit Council, the International Tree Nut Council Research and Education Foundation, Loblaw Brands Ltd., the Peanut Institute, Pulse Canada, and Unilever. He has received in-kind research support from the Almond Board of California, Barilla, the CaliforniaWalnut Commission, Kellogg Canada, Loblaw Companies, Nutrartis, Quaker (PepsiCo), the Peanut Institute, Primo, Unico, Unilever, and WhiteWave Foods/Danone. He has received travel support and/or honoraria from Barilla, the CaliforniaWalnut Commission, the Canola Council of Canada, General Mills, the International Nut and Dried Fruit Council, the International Pasta Organization, Lantmannen, Loblaw Brands Ltd., the Nutrition Foundation of Italy, Oldways Preservation Trust, Paramount Farms, the Peanut Institute, Pulse Canada, Sun-Maid, Tate & Lyle, Unilever, and White Wave Foods/Danone. He has served on the scientific advisory board for the International Tree Nut Council, the International Pasta Organization, the McCormick Science Institute, and Oldways Preservation Trust. He is a founding member of the International Carbohydrate Quality Consortium (ICQC), the Chair of the Diabetes and Nutrition Study Group (DNSG) of the European Association for the Study of Diabetes (EASD), is on the Clinical Practice Guidelines Expert Committee for Nutrition Therapy of the EASD, and is a Director of Glycemia Consulting and the  Toronto 3D Knowledge Synthesis and Clinical Trials foundation. J.L.S. has received research support from the Canadian Foundation for Innovation, the Ontario Research Fund, the Province of Ontario
Ministry of Research and Innovation and Science, the Canadian Institutes of health Research (CIHR),  Diabetes Canada, the American Society for Nutrition (ASN), the International Nut and Dried Fruit Council (INC) Foundation, the National Honey Board (U.S. Department of Agriculture [USDA] honey “Checkoff” program), the Institute for the Advancement of Food and Nutrition Sciences (IAFNS; formerly ILSI North America), Pulse Canada, the Quaker Oats Center of Excellence, the United Soybean Board (USDA soy “Checkoff” program), the Tate and Lyle Nutritional Research Fund at the University of Toronto, the Glycemic Control and Cardiovascular Disease in Type 2 Diabetes Fund at the University of Toronto (a fund established by the Alberta Pulse Growers), the Plant Protein Fund at the University of Toronto (a fund which has received contributions from IFF), and the Nutrition Trialists Network Fund at the University of Toronto (a fund established by an inaugural donation from the Calorie Control Council). He has received food donations to support randomized controlled trials from the Almond Board of California, the California Walnut Commission, the Peanut Institute, Barilla, Unilever/Upfield, Unico/Primo, Loblaw Companies, Quaker, Kellogg Canada, WhiteWave Foods/Danone, Nutrartis, and Dairy Farmers of Canada. He has received travel support, speaker fees and/or honoraria from ASN, Danone, Dairy Farmers of Canada, FoodMinds LLC, Nestlé, Abbott, General Mills, Nutrition Communications, the International Food Information Council (IFIC), the Calorie Control Council, the International Sweeteners Association, and the International Glutamate Technical Committee. He has or has had ad hoc consulting arrangements with Perkins Coie LLP, Tate & Lyle, Phynova, and Inquis Clinical Research. He is a former member of the European Fruit Juice Association Scientific Expert Panel and a former member of the Soy Nutrition Institute (SNI) Scientific Advisory Committee. He is on the Clinical Practice Guidelines Expert Committees of Diabetes Canada, the European Association for the study of Diabetes (EASD), the Canadian Cardiovascular Society (CCS), and Obesity Canada/Canadian Association of Bariatric Physicians and Surgeons. He serves or has served as an unpaid member of the Board of Trustees and an unpaid scientific advisor for the Carbohydrates Committee of IAFNS. He is a member of the International Carbohydrate Quality Consortium (ICQC), an Executive Board Member of the Diabetes and Nutrition Study Group (DNSG) of the EASD, and a Director of the Toronto 3D Knowledge Synthesis and Clinical Trials foundation. His spouse is an employee of AB InBev. R.Z. and S.B. have no conflicts of interest to declare.

I have been sent so many examples of industry-funded studies that I can’t keep up with them.  This is a slow news week and I’m traveling, so how about I post several.  Here’s the first.

My thanks to Katie Iwanowski for sending this one.

The study: The Relationship of Ready-to-Eat Cereal Intake and Body Weight in Adults: A Systematic Review of Observational Studies and Controlled Trials Lisa M. Sanders, Mary R. Dicklin, Yong Zhu, Kevin C. Maki.  Advances in Nutrition, Volume 14, Issue 4, 2023, Pages 671-684.  https://doi.org/10.1016/j.advnut.2023.05.001.

Results:  RTEC[Ready to Eat Cereal] consumers (2 – 4 servings a week), as compared with non- and less frequent consumers have lower BMI, lower prevalence of overweight/obesity, less weight gain over time,  less anthropometric evidence of abdominal adiposity.

Conclusions:

• RTEC may be used as a meal or snack replacement as part of a hypocaloric diet, but this approach is not superior to other options for those attempting to achieve an energy deficit.
• RTEC consumption was not associated with significantly less loss of body weight, or with weight gain, in any of the RCTs.
• RTEC intake is associated with favorable body weight outcomes in adults in observational studies.
• RTEC does not hinder weight loss when used as a meal or snack replacement within a hypocaloric diet.

Funding: This research was funded by Bell Institute of Health and Nutrition, General Mills Inc. The funding sponsor commented on the study design’s early aspects, reviewed the final data, and provided input to the manuscript.

Author disclosures: LMS is a consulting scientist, and MRD and KCM are employees of Midwest Biomedical Research, which has received research funding from General Mills Inc and Kellogg Company. LMS has received funding from Kellogg Company. YZ is an employee of General Mills Inc.

Comment: This cereal study was funded by a cereal company which—this is quite unusual—disclosed its involvement in the study’s design, interpretation, and writing.  The study results are a classic example of interpretation bias.  Basically, breakfast cereals don’t make much difference to body weight (it’s overall calorie balance that counts), but the conclusions are spun positively.  I especially like the double negative, “not associated with significantly less loss….”

I learned about this one as I often do from reading NutraIngredients’ daily newsletter:  RCT: Grape and blueberry extract improves cognitive health in ageing consumers.

This sounds great!  I went right to the article.

The study:  Effects of a polyphenol-rich grape and blueberry extract (Memophenol™) on cognitive function in older adults with mild cognitive impairment: A randomized, double-blind, placebo-controlled study   Adrian L. Lopresti, Stephen J. Smith, Camille Pouchieu Line Pourtau, David Gaudout, Véronique Pallet⁴ and Peter D. Drummond.  Front. Psychol., 29 March 2023.  Volume 14 – 2023 | https://doi.org/10.3389/fpsyg.2023.1144231

Background: Polyphenols are naturally occurring organic compounds found in plants. Research suggests that their intake reduces the risk of cognitive decline and related dementias. Grapes and blueberries are polyphenol-rich foods that have attracted attention for their potential cognitive-enhancing effects.

Purpose: Examine the effects of supplementation with a standardized and patented polyphenol-rich grape and blueberry extract (Memophenol™) on cognitive function in older adults with mild cognitive impairment.

Study design: Two-arm, 6 month, parallel-group, randomized, double-blind, placebo-controlled trial.

Methods: One hundred and forty-three volunteers aged 60 to 80 years with mild cognitive impairment were supplemented with either 150 mg of Memophenol™, twice daily or a placebo. Outcome measures included computer-based cognitive tasks, the Behavior Rating Inventory of Executive Function (BRIEF-A), the Cognitive Failures Questionnaire, and the CASP-19.

Results: Compared to the placebo, Memophenol™ supplementation was associated with greater improvements in the speed of information processing (p = 0.020), visuospatial learning (p = 0.012), and the BRIEF-A global score (p = 0.046). However, there were no other statistically significant between-group differences in the performance of other assessed cognitive tests or self-report questionnaires. Memophenol™ supplementation was well-tolerated with no reports of significant adverse reactions.

Conclusion: The promising results from this trial suggest that 6-months of supplementation with Memophenol™ may improve aspects of cognitive function in adults with mild cognitive impairment. Further research will be important to expand on the current findings and identify the potential mechanisms of action associated with the intake of this polyphenol-rich extract.

Funding: This study received funding from Activ’Inside. The funder was not involved in data collection, interpretation of data, or the decision to submit it for publication.

Conflict of interest: AL is the managing director of Clinical Research Australia, a contract research organization that has received research funding from nutraceutical companies. AL has also received presentation honoraria from nutraceutical companies. SS is an employee of Clinical Research Australia and declares no other conflicts of interest. PD and VP declare no conflicts of interest. DG, CP, and LP are employed at Activ’Inside and provided the Memophenol™ and placebo capsules.

Comment: Guess what Activ’Inside makes.  This study is not only funded by the maker of the supplement, but three of the authors work for the company.  This is contract research.  How can they say the funder was not involved?  The authors may not recognize it, but the funder was involved, and deeply.  How could it not be if the authors work for the company?

Oxygen nanobubbles?  Oxygen in little tiny bubbles?

For this gem I am indebted to an item I read in NutraIngredients-Europe:

Oxygen nanobubble drink found to enhance athletic performance, study suggestsA new study finds the consumption of an oxygen nanobubble beverage significantly improves the time-to-completion of maximal and submaximal exercises performed by male cyclists…. Read more

I went right to the article.

The study: A Double-Blind, Randomized, Placebo-Controlled Pilot Study examining an Oxygen Nanobubble Beverage for 16.1-km Time Trial and Repeated Sprint Cycling Performance.  Journal of Dietary Supplements. https://doi.org/10.1080/19390211.2023.2203738.

The concept: Athletes need oxygen and water.  Therefore, oxygen-supplemented water should improve performance.

The result: As comparied to placebo, Althletes who consumed the oxygen-nanobubble beverage demonstrated significantly improved performance.

The conclusion:  “An oxygen-nanobubble beverage improves performance during submaximal and repeated sprint cycling, therefore may provide a practical and effective ergogenic aid for competitive cyclists.”

Guess who funded this: “This study was funded by Avrox Technologies Ltd, Harrogate, North Yorkshire, HG3 3SZ. Avrox Technologies provided the experimental beverages but had no role in study design, data storage, analysis and interpretation.

I wondered what the placebo was and whether study subjects could distinguish the drinks.  The beverages:

were supplied by Avrox Technologies in 500 mL individually sealed bottles and consisted of the same solution containing water, glycerol, glycyrrhizin, lecithin and citric acid. Both beverages have similar organoleptic properties, including taste, aroma, and texture. Previous investigations have indicated that the oxygen nanobubble drink consists of a suspension of lecithin vesicles with a modal diameter of ∼100 nm and concentration 7 × 1012 particles/ml.

The authors deal with my question in their discussion of the study’s limitations:

we did not evaluate the success of our double-blind design, therefore, changes in performance might be somewhat attributed to participants’ expectancy of positive outcomes from their belief that they successfully identified the O₂ beverage…Whilst there were no notable differences in taste, texture or appearance of the O₂ and PLA [not spelled out in the study but must refer to the placebo] beverages, we should have assessed blinding via treatment allocation questionnaires to determine whether participant biases influenced results.

Yes, you should have.

I also wonder whether club soda or Pellegrino might have the same benefit?  Or giving water a good shake?