Currently browsing posts about: Sponsored-research

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?

Christina Leffel, a public health nutritionist in Florida, sent this one, which with both find amusing.

The study: Effects of Adding Lean Red Meat to a U.S.-Style Healthy Vegetarian Dietary Pattern on Gut Microbiota and Cardiovascular Risk Factors in Young Adults: a Crossover Randomized Controlled Trial – The Journal of Nutrition.  VOLUME 153, ISSUE 5, P1439-1452, MAY 2023, https://doi.org/10.1016/j.tjnut.2023.03.013

Method:  19 participants consumed 3 study diets in random order: 1) healthy lacto-ovo vegetarian diet (LOV); 2) LOV plus 3 ounces/d of cooked unprocessed lean red meat (URM); and 3) LOV plus 3 ounces/d of cooked processed lean red meat (PRM). Measures: Fecal and fasting blood samples.

Results: The addition of unprocessed or processed lean red meats to a LOV HDP did not influence short-term changes in bacterial taxonomic composition.  When the data from all three diets were combined, “changes in some bacteria were associated with improvements in TC, LDL-C, triglycerides, and HDL-C concentrations, and TC/HDL-C ratio.”

Conclusions:  Healthy young adults who adopt an HDP that may be vegetarian or omnivorous, including lean red meat, experience short-term changes in gut microbial composition, which associate with improvements in multiple lipid-related cardiovascular risk factors.

Funding: “The study was cofunded by the Pork Checkoff, North Dakota Beef Commission, Beef Checkoff, and Foundation for Meat and Poultry Research and Education. The supporting sources had no role in study design; collection, analysis, and interpretation of data; writing of the report; or submission of the report for publication.

Author disclosures: “During the time this review was conducted, WWC received funding for research grants, travel or honoraria for scientific presentations, or consulting services from the following organizations: U.S. National Institutes of Health, U.S. Department of Agriculture (Hatch Funding), Pork Checkoff, National Pork Board, Beef Checkoff, North Dakota Beef Commission, National Cattlemen’s Beef Association, Foundation for Meat and Poultry Research and Education, American Egg Board, Whey Protein Research Consortium, National Dairy Council, Barilla Group, Mushroom Council, and the National Chicken Council. Additionally, SRL received funding for research grants, travel or honoraria for scientific presentations, or consulting services from the following organizations: U.S. National Institutes of Health, U.S. Department of Agriculture, National Science Foundation, Showalter Research Trust, Grain Foods Foundation, CP Kelco US, OLIPOP, Inc, Council for Responsible Nutrition. YW, T-WLC, MT, and CMC declare no conflict of interest. The funder and these other organizations had no role in the design and conduct of the study, analysis, interpretation of the results, and writing of the manuscript.”

Comment: This is yet another industry-funded study in which the funder claims no role–a statement that always makes me laugh.  That’s what they all say, despite much evidence that the funding influence in such situations can be considerable, although unrecognized.  For details, see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

The meat industry, apparently, is trying to convince vegetarians that they can eat any kind of meat they want and not affect their cardiovascular risk.  This, of course, contradicts tons of other evidence, including associations with cancer risk.  These risks may not be mediated through the microbiome, however.  What this study says is that if you are worried about the risks of meat, you don’t have to worry that it changes your microbiome much, at least under the conditions of this study.

The workshop covered the ways that funding sources (especially corporate funders) influence research quality and outcomes (precisely the topic of my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

The report is a succinct yet thorough summary of the research on the effects of funding on research design, outcome, and interpretation.

Some of the speakers:

• Lisa Bero, PhD, Chief Scientist, Center for Bioethics and Humanities, at the University of Colorado Anschutz Medical Campus, Overview of the Evidence on Sponsor Influence
• David Michaels PhD, MPH, epidemiologist and professor at the George Washington University School of Public Health; former Assistant Secretary of Labor for the OSHA. How to Protect Public Health in the Face of Disinformation.
• Gary Ruskin, Executive Director, U.S. Right to Know,  Where are the points of influence on scientific research?
• Martin McKee, CBE, MD, president of the British Medical Association and Professor of European Public Health at the London School of Hygiene and Tropical Medicine. What You Don’t See That Counts: A Peek Behind the Smokescreen
• Laura A. Schmidt, PhD, Professor Health Policy in the School of Medicine at the University of California at San Francisco. Industry Funding Bias in the Case of Nutrition Science

This report is a great place to begin if the topic is new to you.

And so is this, of course.

Here’s another one that several readers have asked me about: Multivitamin Supplementation Improves Memory in Older Adults: A Randomized Clinical Trial.  Authors: Lok-Kin Yeung, Daniel M. Alschuler, Melanie Wall, Howard D. Sesso, JoAnn E. Manson, Adam M. Brickman.  American Journal of Clinical Nutrition. DOI:https://doi.org/10.1016/j.ajcnut.2023.05.011

The study: “Participants were randomly assigned to a daily multivitamin supplement (Centrum Silver) or placebo and evaluated annually with an Internet-based battery of neuropsychological tests for 3 y.”  Primary outcome measure: change in episodic memory (immediate recall performance on the ModRey test, after 1 y of intervention).  Secondary outcome measures: changes in episodic memory over 3 y of follow-up,  and in performance on neuropsychological tasks of novel object recognition and executive function over 3 y.

Results: “Compared with placebo, participants randomly assigned to multivitamin supplementation had significantly better ModRey immediate recall at 1 y, the primary endpoint (t(5889) = 2.25, P = 0.025), as well as across the 3 y of follow-up on average (t(5889) = 2.54, P = 0.011). Multivitamin supplementation had no significant effects on secondary outcomes…we estimated that the effect of the multivitamin intervention improved memory performance above placebo by the equivalent of 3.1 y of age-related memory change.”

Conflict of interest: HDS, JEM, and AMB received investigator-initiated grant support to their institutions from Mars Edge. Pfizer Consumer Healthcare (now Haleon) provided support through the partial provision of study pills and packaging. HDS received investigator-initiated grants from Pure Encapsulations and Pfizer Inc and honoraria and/or travel for lectures from the Council for Responsible Nutrition, BASF, NIH, and the
American Society of Nutrition during the conduct of the study. No funding sources had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and the decision to submit the manuscript for publication.

Funding: This work was supported by an investigator-initiated grant from Mars Edge, a segment of Mars Inc dedicated to nutrition research. Pfizer Consumer Healthcare (now Haleon) provided support through the
partial provision of study pills and packaging.

Comment:  This study continues to surprise me.  As I’ve written before, it is part of the COSMOS trial, which is also supported by grants from NIH and a private foundation.  In my previous post on it, I noted that despite being funded by Pfizer (which makes Centrum Silver multivitamin supplements), the study did not show benefits of the supplement for prevention of cardiovascular disease or cancer—a rare exception to the rule that industry-funded studies tend to favor the sponsor’s interests.  But here we go again, this time with an equally surprising result but for a different reason: most multivitamin studies have shown no benefits whereas this one says if you take Centrum Silver, it will give you another three years of no loss in memory.  Wow!  I’ll be Pfizer is thrilled.

Here’s what the NIH National Center for Complementary and Integrative Health says about multivitamins:

Thanks to Bradley Flansbaum for sending this one from a journal not on my usual reading list: “In persons with constipation or IBS-C, kiwifruit vs. psyllium increased spontaneous bowel movements.”

I like the way this press release gets right to the point.

An industry-funded randomized trial assessed the effect of daily consumption of kiwifruit versus psyllium on GI function and comfort in 184 adults who were healthy, had functional constipation (FC), or met Rome III diagnostic criteria for constipation-predominant irritable bowel syndrome (IBS-C).

The study: Consumption of 2 Green Kiwifruits Daily Improves Constipation and Abdominal Comfort—Results of an International Multicenter Randomized Controlled Trial.  The American Journal of Gastroenterology ():10.14309/ajg.0000000000002124, January 9, 2023. | DOI: 10.14309/ajg.0000000000002124.

Authors: Gearry, Richard MD, PhD; Fukudo, Shin MD, PhD; Barbara, Giovanni MD; Kuhn-Sherlock, Barbara PhD; Ansell, Juliet PhD; Blatchford, Paul PhD; Eady, Sarah MSc; Wallace, Alison PhD; Butts, Christine PhD; Cremon, Cesare MD; Barbaro, Maria Raffaella PhD; Pagano, Isabella MD; Okawa, Yohei PhD; Muratubaki, Tomohiko PhD; Okamoto, Tomoko PhD; Fuda, Mikiko MS; Endo, Yuka MD; Kano, Michiko MD, PhD; Kanazawa, Motoyori MD, PhD; Nakaya, Naoki PhD; Nakaya, Kumi PhD; Drummond, Lynley BTech (Hons)

Summary of the study

Methods: Participants included healthy controls (n = 63), patients with functional constipation (FC, n = 60), and patients with constipation-predominant irritable bowel syndrome (IBS-C, n = 61) randomly assigned to consume 2 green kiwifruits or psyllium (7.5 g) per day for 4 weeks, followed by a 4-week washout, and then the other treatment for 4 weeks. The primary outcome was the number of complete spontaneous bowel movements (CSBM) per week.

Results: Consumption of green kiwifruit was associated with a clinically relevant increase of ≥ 1.5 CSBM per week (FC; 1.53, P < 0.0001, IBS-C; 1.73, P = 0.0003) and significantly improved measures of GI comfort (GI symptom rating scale total score) in constipated participants (FC, P < 0.0001; IBS-C, P < 0.0001).

Conclusion: This study provides original evidence that the consumption of a fresh whole fruit has demonstrated clinically relevant increases in CSBM and improved measures of GI comfort in constipated populations. Green kiwifruits are a suitable dietary treatment for relief of constipation and associated GI comfort.

Financial support: Zespri International Ltd. was the principal sponsor and reviewed, approved, and funded the study design. The New Zealand study center trial was jointly funded by a grant from the New Zealand government (Contract C11X1312) and the sponsor company, Zespri International Ltd. In Italy and Japan, Zespri International Ltd. was the sole funder for each study center trial. The funder did not contribute to the study design or data analysis.

Potential competing interests: J.A. and P.B. are employed by Zespri International who part-funded the study. R.G. and L.D. sit on the Science Advisory Board, have received travel and research grants from Zespri International. SF and GB have received research travel grants from Zespri International.

Comment:  Can you guess what Zespri International sells?  Go on.  Take a wild guess.  I’ll admit it.  I’d go for kiwi over psyllium every time.  But we are talking here about an average improvement of 1.5 bowel movements a week, which may or may not be clinically meaningful..  I do give the authors credit for claiming a benefit for “fresh whole fruit,” not specifically kiwifruit.  The study didn’t compare kiwi to other fruits (and why would it, given the kiwi fruit sponsor).  But overall, this is yet another study done for marketing far more than scientific purposes.

Thanks to reader Maira Bes-Rastrollo at the University of Navarra in Spain (and whose work I greatly admire) for this one.

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 https://doi.org/10.1016/j.advnut.2023.05.001