Currently browsing posts about: Sponsored-research

The Study: Whole cranberry fruit powder supplement reduces the incidence of culture-confirmed urinary tract infections in females with a history of recurrent urinary tract infection: A 6-month multicenter, randomized, double-blind, placebo-controlled trial.Stonehouse, Welma et al. The American Journal of Clinical Nutrition, Volume 121, Issue 4, 932 – 941

Methods: “This multicenter, 6-mo, randomized, placebo-controlled, double-blind study enrolled 150 healthy females [18–65 y, body mass index (BMI) >17.5 and <35 kg/m²] with rUTI defined as ≥3 UTIs in the last year or ≤2 UTIs in the last 6 mo, excluding those with >5 UTIs in the last 6 mo. Participants consumed either 1 capsule of 500 mg/d of whole cranberry powder (Pacran) or placebo.”

Results: “Whole cranberry powder capsules reduced culture-confirmed UTI risk compared with placebo by 52%…reduced Escherichia coli UTIs…reduced incidence of UTI with urinary frequency and urgency symptomatology; delayed time to first UTI episode…and reduced the mean total number of UTIs per participant.”

Conclusion: “This study shows that whole cranberry powder capsules do not impact safety markers and reduce the incidence of culture-confirmed UTI and several other UTI-related outcomes in healthy females with rUTI history.”

Conflict of interest: “Financial sponsorship for the study was provided by Swisse Wellness Pty Ltd to the Commonwealth Scientific Industrial Research Organisation. All authors report no conflicts of interest.”

Funding: “Swisse Wellness Pty Ltd was the trial sponsor and Givaudan Flavors Corp was the raw material supplier.”

Disclaimers: “The funding source and the raw material supplier, in collaboration with the research scientists, designed the trial and monitored its implementation, but had no influence over the analyses, reporting, interpretation of the data and preparation of the manuscript. The manuscript was reviewed by the sponsor and the raw material supplier before the submission to the journal, but they had no influence over the manuscript content.”

Comment: You should not be surprised to learn that the funder, Swisse Wellness Pty Ltd, makes “supplements for everyday lifestyle.” among them cranberry supplements.  The raw material supplier, Givaudan, sells cransberry oil.  The disclaimer reveals that both companies  designed the trial, were involved throughout, and reviewed the manuscript.  The authors consider all this to constitute “no influence,” in quotes because it is impossible to avoid influence under these circumstances.  At the very least, the companies would make sure the study design had little chance of coming up with the wrong result.  This is an industry-funded study with predictable results that will help them sell cranberry powder.  I hope it works.

Thanks again to Jim Krieger of Healthy Food America for sending this one.

The study: Sievenpiper JL, Purkayastha S, Grotz VL, Mora M, Zhou J, Hennings K, Goody CM, Germana K. Dietary Guidance, Sensory, Health and Safety Considerations When Choosing Low and No-Calorie Sweeteners [LNCSs]. Nutrients. 2025 Feb 25;17(5):793. doi: 10.3390/nu17050793.

The greater sweetness intensity of LNCSs compared to sucrose allows for the use of lesser amounts to achieve a similar level of sweetness, facilitating a reduction in an individual’s caloric and sugar consumption. Furthermore, the substitution of LNCSs for sugar supports individual and public health outcomes by addressing issues related to obesity, diabetes, and chronic illnesses…Lastly, emerging evidence from in vitro and a randomized controlled trial have investigated food intake and satiety management and suggests that natural LNCSs may be beneficial…The diverse range of LNCSs available in global food and beverage choices, coupled with their varying sweetness intensities, offers enjoyment and pleasure to consumers on their respective health and wellness journeys.

Conflict of interest statement: The following authors are employed at Ingredion, Inc.: Margaux Mora, Jing Zhou, Katie Hennings, and Kristen Germana. The following authors received an honorarium from Ingredion, Inc. for professional services provided: John L. Sievenpiper, Sidd Purkayastha, V. Lee Grotz and Cynthia Goody. Dr. John L Sievenpiper has received research support from the Canadian Foundation for Innovation, Ontario Research Fund, Province of Ontario Ministry of Research and Innovation and Science, Canadian Institutes of health Research (CIHR), Diabetes Canada, American Society for Nutrition (ASN), National Honey Board (U.S. Department of Agriculture [USDA] honey “Checkoff” program), Institute for the Advancement of Food and Nutrition Sciences (IAFNS), Pulse Canada, Quaker Oats Center of Excellence, INC International Nut and Dried Fruit Council Foundation, The United Soybean Board (USDA soy “Checkoff” program), Protein Industries Canada (a Government of Canada Global Innovation Cluster), Almond Board of California, European Fruit Juice Association, 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 among other donors), The Plant Milk Fund at the University of Toronto (a fund established by the Karuna Foundation through Vegan Grants), and The Nutrition Trialists Network Fund at the University of Toronto (a fund established by donations from the Calorie Control Council, Physicians Committee for Responsible Medicine, and Login5 Foundation). He has received food donations to support randomized controlled trials from the Almond Board of California, California Walnut Commission, Danone, Nutrartis, Soylent, and Dairy Farmers of Canada. He has received travel support, speaker fees and/or honoraria from FoodMinds LLC, Nestlé, Abbott, General Mills, Nutrition Communications, International Food Information Council (IFIC), Arab Beverage Association, International Sweeteners Association, Calorie Control Council, and Phynova. He has or has had ad hoc consulting arrangements with Almond Board of California, Perkins Coie LLP, Tate and Lyle, Ingredion, and Brightseed. He is on the Clinical Practice Guidelines Expert Committees of Diabetes Canada, European Association for the study of Diabetes (EASD), Canadian Cardiovascular Society (CCS), and Obesity Canada/Canadian Association of Bariatric Physicians and Surgeons. He serves as an unpaid member of the Board of Trustees of IAFNS. He is a Director at Large of the Canadian Nutrition Society (CNS), founding member of the International Carbohydrate Quality Consortium (ICQC), Executive Board Member of the Diabetes and Nutrition Study Group (DNSG) of the EASD, and Director of the Toronto 3D Knowledge Synthesis and Clinical Trials foundation. His spouse is a former employee of Nestle Health Science and AB InBev.

If you have any doubts about the value of the concept of ultra-processed, the breadth and extent of industry pushback against the idea is excellent evidence.  The concept is an existential threat to the processed food industry, and it is fighting back.  The Italian food industry is especially concerned because it also has the Nutri-Score front-of-pack labeling system to contend with; the letter grades on ultra-processed products tend to be C’s, D’s, and E’s—as bad as they come.

Here’s an example of the pushback.

The opinion piece: Visioli, F., Del Rio, D., Fogliano, V., Marangoni F, Ricci C, Poli A.  Ultra-processed foods and health: are we correctly interpreting the available evidence?. Eur J Clin Nutr 79, 177–180 (2025). https://doi.org/10.1038/s41430-024-01515-8

Competing interests: AP and FM are the Chairman and Scientific Director, respectively, of NFI—Nutrition Foundation of Italy, a non-profit organisation partially supported by Italian and non-Italian Food Companies. All other authors declare no conflict of interest associated with this publication.

Comment: The senior (last) author and one other run the Italian Nutrition Foundation, an organization sponsored by food companies, Italan and international.  This makes the Foundation an industry front group, pretending to be independent, but not.  Its job is to further the commercial interests of its corporate sponsors, which is what it is doing here.  It is using the tobacco industry playbook: cast doubt on the research, suggest alternatives, argue against regulation.  The foundation’s authors are joined by academic and government authors, who have their own, not necessarily commercial, reasons for unhappiness with the UPF concept, which focuses on degree of processing, not nutrient content.  Yes, nutrients matter, but there are better ways of getting them than through UPFs.

The Study:  Prunes May Blunt Adverse Effects of Oral Contraceptives on Bone Health in Young Adult Women: A Randomized Clinical Trial.  DeMasi, Taylor et al.  Current Developments in Nutrition, Volume 8, Issue 9, 104417.

The rationale: Oral contraceptives (OCs) may promote bone loss.  Prunes may prevent that.

Objective: Will consuming 50 g of prunes daily prevent bone loss or increase bone accrual in OC users.

Methods: Ninety women were randomly assigned to a control group not using OCs (non-OC), an OC group not consuming prunes (OC), and an OC group consuming 50 g prunes daily (OC+P) for 12 mo.

Results:  Bone mineral density (BMD) did not change among groups, but ultradistal radius BMD increased over time within non-OC and OC+P groups. Trabecular density of the distal tibia decreased within the OC group.

Conclusions: OC use promoted minor negative effects on bone.  Consuming prunes “tended to provide a potential protective effect on trabecular density of the distal tibia and ultradistal radius in young women.”

Conflict of interest: “The authors report no conflict of interest.”

Funding: “This study was funded by the California Prune Board. The California Prune Board had no 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 decision to submit the manuscript for publication.”

Comment: I’ve put the wiggle words in red.  Why, you might well ask, would anyone expect two ounces of prunes a day to have anything to do with bone loss?  The authors do not say.  They merely observe an association of prunes with bone health in animals, and say they had seen minor prevention of bone loss in postmenopausal women in previous research.  I’m all for eating prunes if you like them, but bone health seems like a stretch.  So does the statement that the Prune Board had no role in the study.  It funded the study.  It is not going to fund studies that might not produce favorable results.  Industry funding exerts influence from the get go, whether or not recognized by authors as a conflict of interest.

Jim Krieger of Healthy Food America forwarded this email announcement sent to members of the American Society for Nutrition (I am a member, but somehow missed this).  It’s an example of how industry-funded research gets started.

This is a sponsored message from the American Pistachio Growers, an ASN [American Society for Nutrition] Sustaining Partner.

But you can see how this works.  The Pistachio trade association is looking for research to show how eating pistachios enhances sleep, improves performance, and supports weight management (like taking GLP-1 drugs).

If research proposals do not support these objectives, they won’t be funded.

I realize I’m posting this too late for you to apply and test this statement.  Sorry about that.  Next time!

A dietitian member of the Academy of Nutrition and Dietetics, who wishes to remain anonymous, emailed me about PepsiCo’s guide to research interpretation.

PepsiCo sent dietitians this webinar and handout for communicating nutrition science and evaluating studies. I took a look at the handout, which gives a “high quality research” distinction to any studies in which authors have clearly disclosed conflict of interest. So … As long as it’s disclosed, it can be high quality research?  Ok.

The handout: How to Communicate Nutrition Science Effectively.

As a credentialed healthcare professional, you have the power to inspire trust and deepen the general public’s understanding of nutrition through credible scientific communication. Let this guide help you to better understand scientific publications and to improve your effectiveness as a nutrition communicator.

Here’s what got the attention of my reader:

According to PepsiCo, high-quality science requires publication in a reputable, peer-reviewed journal, results based on the totality of evidence, conflicts of interest disclosed, and ethical questions, societal implications, limitations discussed.

This is good advice.

But as noted by my reader, disclosure of conflicts of interest should not be sufficient to determine research quality.

Disclosure is essential, but not enough to resolve the problems of conflict of interest.

As I endlessly repeat in these Monday posts, the recipients of industry funding rarely recognize the risk of undue influence; they did not intend to be influenced, and they believe themselves to be immune from the influence—despite the fact that tons of research shows otherwise.

Food companies fund research for reasons that have everything to do with marketing and little to do with science.  They do not fund research if they think it might show harm from their products.

Yes, this is a complicated issue.  But consider the benefit to PepsiCo from engaging dietitians in this endeavor.

The study: Amone F, Spina A, Perri A, Lofaro D, Zaccaria V, Insolia V, Lirangi C, Puoci F, Nobile V. Standardized Grape (Vitis vinifera L.) Extract Improves Short- and Long-Term Cognitive Performances in Healthy Older Adults: A Randomized, Double-Blind, and Placebo-Controlled Trial. Foods. 2024; 13(18):2999. https://doi.org/10.3390/foods13182999

The headline:  “Just 2 handfuls of pistachios daily could help protect your eyesight.”

Really?  Let’s take a look.

The Study: Pistachio Consumption Increases Macular Pigment Optical Density in Healthy Adults: A Randomized Controlled Trial.  Scott, Tammy M et al.  The Journal of Nutrition, Volume 155, Issue 1, 168 – 174. 2024 Oct 18:S0022-3166(24)01099-X.   doi: 10.1016/j.tjnut.2024.10.022.

Background: Pistachios are a bioavailable source of the xanthophyll lutein. Along with zeaxanthin, these plant pigments are major components of macular pigment (MP) in the human retina. MP can be non-invasively measured and is referred to as MP optical density (MPOD). MPOD is modifiable with dietary interventions that include lutein and zeaxanthin (L/Z). Higher MPOD protects the eye from light damage and is positively associated with eye health.

Objectives: This dietary intervention study aimed to evaluate the effect of pistachio consumption on MPOD.

Method: This single-blinded, randomized controlled trial compared a 12-week pistachio intervention (2 oz/d) with usual diet (UD) on MPOD and serum L/Z in middle-aged to older healthy adults (n = 36) in a 1:1 randomization scheme.

Conclusions: The results of our study demonstrate that a dietary intervention with pistachios is efficacious in increasing MPOD in healthy adults selected for habitually low intake of L/Z and low baseline MPOD. This suggests that pistachio consumption could be an effective dietary strategy for preserving eye health. Future studies need to evaluate the generalizability of our findings to other populations.

Funding: This project was supported by the American Pistachio Growers, who had no role in the final design, conduct, or interpretation of this study. The project described was also supported by the National Center for Advancing Translational Sciences, National Institutes of Health, Award Number UM1TR004398. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Conflict of interest: Tammy M Scott reports financial support provided by American Pistachio Growers. The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Comment: When I saw the title, I wanted to know immediately, “Who paid for this?”  If you eat foods containing lutein and zeaxanthin, the levels of those factors will increase.  No surprise.  Are pistachios the only or best way to do this?  That’s not what this study aimed to find out.  This, as is true of much (most) industry-funded studies, this one is more about marketing than science.