Currently browsing posts about: Sponsored-research

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.

Charles Platkin sent me this  article from Food Manufacturing: “Eating pork linked with better handgrip strength, industry group says.”

I quickly found the The Pork Board’s press release.

And went right to the source.

The study: Jung A-J, Sharma A, Chung M, Wallace TC, Lee H-J. he Relationship of Pork Meat Consumption with Nutrient Intakes, Diet Quality, and Biomarkers of Health Status in Korean Older Adults.  Nutrients. 2024; 16(23):4188. https://doi.org/10.3390/nu16234188

Objectives: We evaluated the association between pork meat consumption and nutrient intake, diet quality, and biomarkers of health among older adults (age ≥ 65 years) in Korea.

Methods: Our analyses utilized dietary and health examination data from the 2016–2020 Korean National Health and Nutrition Examination Survey (n = 2068).

Results: Pork consumption was associated with  a higher intake of energy and [some] nutrients…Diet quality was modestly higher among…pork consumers. Differences in biomarkers were clinically irrelevant…Handgrip strength was slightly higher.

Conclusions: In Korean older adults, pork consumption may contribute to a higher intake of energy and most nutrients, improved diet quality scores, higher vegetable intake, and small improvements in health biomarkers.

Funding: Funding for this research was provided through an investigator-initiated educational grant from the National Pork Board (#22-056) to Think Healthy Group, LLC. The sponsor had no role in the design, analysis, interpretation, or presentation of the data or results. The authors and sponsor strictly adhered to the American Society for Nutrition’s guiding principles for private funding for food science and nutrition research. M.C. did not receive salary support or consulting fee from this grant.

Conflicts of interest”: T.C.W. has received scientific consulting fees as a current member of the Science Advisory Board for the National Pork Board. He has also received other investigator-initiated educational research grants from the National Pork Board. All other authors have no conflicts of interest to declare.

Comment: Applause to Food Manufacturing for noting the industry  source in its headline: “industry group says”.  Note the effect size: “small improvements in health biomarkers.”  Nevertheless, the Pork Board thought it was worth a press release—it had paid for the study, after all.  The Pork Board runs a USDA-sponsored checkoff program; it collects fees from pork producers and uses them for purposes like these.  Worth it?  A lot of pork producers don’t think so, but the USDA insists and manages it through its Agricultural Market Service.  I wonder if the new administration will take interest in such programs…?

In its scientific report, the 2025-2030 Dietary Guidelines Advisory Committee recommends substituting plant proteins for animal proteins.

The Committee recommends that the proposed Eat Healthy Your Way Dietary Pattern emphasizes dietary intakes of beans, peas, and lentils while reducing intakes of red and processed meats….The Committee also proposes reorganizing the order of the Protein Foods Group to list Beans, Peas, and Lentils first, followed by Nuts, Seeds, and Soy products, then Seafood, and finally Meats, Poultry, and Eggs.

It did not take long for the meat industry to respond: Animal vs. Plant Protein: New Research Suggests That These Protein Sources Are Not Nutritionally Equivalent.

As is my habit, I went right to the study.

The study: Connolly G, Hudson JL, Bergia RE, Davis EM, Hartman AS, Zhu W, Carroll CC, Campbell WW. Effects of Consuming Ounce-Equivalent Portions of Animal- vs. Plant-Based Protein Foods, as Defined by the Dietary Guidelines for Americans on Essential Amino Acids Bioavailability in Young and Older Adults: Two Cross-Over Randomized Controlled Trials. Nutrients. 2023; 15(13):2870. https://doi.org/10.3390/nu15132870

Conclusions: “The same “oz-eq” portions of animal- and plant-based protein foods do not provide equivalent EAA content and postprandial bioavailability for protein anabolism in young and older adults.”

Funding: “This research was funded by the Pork Checkoff and the American Egg Board—Egg Nutrition Center. 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.”

Conflicts of Interest: “When this research was conducted, W.W.C. received research funding from the following organizations: American Egg Board’s Egg Nutrition Center, Beef Checkoff, Pork Checkoff, North Dakota Beef Commission, Barilla Group, Mushroom Council, and the National Chicken Council. C.C.C. received funding from the Beef Checkoff. R.E.B. is currently employed by Archer-Daniels-Midland (ADM); the research presented in this article was conducted in a former role and has no connection with ADM. G.C., J.L.H., E.M.D., A.S.H. and W.Z. declare no conflict of interest. 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.”

Comment: Amino acids, the building blocks of protein, are the same whether they come from plants or animals (or us).  Food animals are closer to us evolutionarily than are plants; the animo acid composition of their proteins is more like ours than the amino acid composition of food plants.  That is why protein complementarity matters; mix and match the plants you eat and their amino acid compositions will complement each other and fill in the gaps.  This doesn’t even have to be done at every meal.  Overall, it’s easier to get the needed amino acids from animal foods but it’s not all that hard to get them from plants as long as they are varied and you eat enough of them.  So the study isn’t wrong; it’s just not telling the whole story.

Thanks to Kevin Mitchell for sending this one.

Let’s start the new year off with a classic industry-funded study with predictable results.

Beef Consumption and Cardiovascular Disease Risk Factors: A Systematic Review and Meta-analysis of Randomized Controlled Trials.  Sanders, Lisa M et al. Current Developments in Nutrition, Volume 8, Issue 12, 104500

Background: Results from observational studies suggest associations of red meat intake with increased risk of cardiovascular disease (CVD); however, RCTs have not clearly demonstrated a link between red meat consumption and CVD risk factors. Further, the specific effects of beef, the most consumed red meat in the United States, have not been extensively investigated.

Objectives: This study aimed to perform a systematic review and meta-analysis of RCT data evaluating the effects of minimally or unprocessed beef intake on CVD risk factors in adults.

Methods: A search of the literature was conducted using PubMed and CENTRAL databases.

Results: Beef intake did not impact blood pressure or most lipoprotein-related variables, including total cholesterol, HDL-cholesterol, triglycerides, non–HDL-cholesterol, apolipoprotein A or B, and VLDL-cholesterol. Beef consumption had a small but significant effect on LDL-cholesterol (0.11; 95% CI: 0.008, 0.20; P = 0.03), corresponding to ∼2.7 mg/dL higher LDL-cholesterol in diets containing more beef than that in low-beef or -o beef comparator diets. Sensitivity analyses show this effect was lost when 1 influential study was removed.

Conclusions: In summary, the results of this analysis showed no meaningful effect of daily unprocessed beef intake, compared with diets with less or no beef, on circulating lipoprotein lipids, apolipoproteins, and blood pressures, except for a small effect to increase the LDL-cholesterol concentration by ∼2.7 mg/dL. Given that unprocessed beef has minimal to no impact on these CVD risk factors but is a significant source of highly bioavailable protein as well as iron, zinc, and selenium, its inclusion in the diet may help improve dietary nutrient profiles without significantly affecting lipids or blood pressures.

Funding: This study was supported by the Beef Checkoff. The funding sponsor provided comments on early aspects of the study design. A report was shared with the sponsor prior to submission. The final decision for all aspects of the study and the manuscript content were those of the authors alone.

Comment:  As I said, an instant classic of the genre.  The USDA-managed Beef Checkoff had input into the study design and got to comment on the results and conclusions before the article was submitted for publication.  The sponsor exerted influence at the two places bias is most often found: the study design and the interpretation of the results.  Hence, industry influenced and predictable.

More to come.  Happy new year!