by Marion Nestle

Currently browsing posts about: Conflicts-of-interest

Mar 8 2016

Another five industry-funded studies with sponsor-favorable results. The score: 145/12

Thanks to a reader for sending these items from a journal that I don’t usually come across.  These bring the casually collected total since last March to 145 studies favorable to the sponsor versus 12 that are not.

Consuming the daily recommended amounts of dairy products would reduce the prevalence of inadequate micronutrient intakes in the United States: diet modeling study based on NHANES 2007–2010Erin E Quann, Victor L Fulgoni III and Nancy Auestad. Nutrition Journal 2015; 14:90 DOI: 10.1186/s12937-015-0057-5

  • Conclusion: Increasing dairy food consumption to recommended amounts is one practical dietary change that could significantly improve the population’s adequacy for certain vitamins and minerals that are currently under-consumed, as well as have a positive impact on health.
  • Funding: The study and the writing of the manuscript were supported by Dairy Management Inc.

Association of lunch meat consumption with nutrient intake, diet quality and health risk factors in U.S. children and adults: NHANES 2007–201Sanjiv Agarwal, Victor L. Fulgoni III and Eric P. Berg. Nutrition Journal. 2015;14:128.  DOI: 10.1186/s12937-015-011f8-9

  • Conclusions: The results of this study may provide insight into how to better utilize lunch meats in the diets of U.S. children and adults.
  • Funding: The present study was funded by North American Meat Institute.

A review and meta-analysis of prospective studies of red and processed meat, meat cooking methods, heme iron, heterocyclic amines and prostate cancerLauren C. Bylsma and Dominik D. Alexander.  Nutrition Journal. 2015;14:125. DOI: 10.1186/s12937-015-0111-3

  • Conclusion: Dose-response analyses did not reveal significant patterns of associations between red or processed meat and prostate cancer….although we observed a weak positive summary estimate for processed meats.
  • Funding: This work was supported in part by the National Cattlemen’s Beef Association (NCBA), a contractor to the Beef Checkoff. NCBA did not contribute to the writing, analysis, interpretation of the research findings, or the decision to publish…LCB and DDA are employees of EpidStat Institute. EpidStat received partial funding from the National Cattlemen’s Beef Association (NCBA), a contractor to the Beef Checkoff, for work related to this manuscript. The conceptualization, writing, analysis, and interpretation of research findings was performed independently.

Are restrictive guidelines for added sugars science based?  Jennifer Erickson and Joanne Slavin.  Nutrition Journal. 2015;14:124.  DOI: 10.1186/s12937-015-0114-0

  • Conclusion: However, there is currently no evidence stating that added sugar is more harmful than excess calories from any other food source. The addition of restrictive added sugar recommendations may not be the most effective intervention in the treatment and prevention of obesity and other health concerns.
  • Disclosure: Jennifer Erickson, is a PhD student in Nutrition at the University of Minnesota working with Dr. Joanne Slavin. Joanne Slavin is a professor in the Department of Food Science and Nutrition, University of Minnesota.  In the past 5 years, she has given 150 scientific presentations in 13 countries. Many of these meetings received sponsorship from companies and associations with an interest in carbohydrates and nutritive sweeteners…Her research funding for the past 5 years has included grants from General Mills, Inc., Tate and Lyle, Nestle Health Sciences, Kellogg Company, USA Rice, USA Pears, Minnesota Beef Council, Minnesota Cultivated Wild Rice Council, Barilla Company, USDA, American Egg Board, American Pulse Association, MNDrive Global Food Ventures, International Life Science Institute (ILSI), and the Mushroom Council. She serves on the scientific advisory board for Tate and Lyle, Kerry Ingredients, Atkins Nutritionals, Midwest Dairy Association and the Alliance for Potato Research and Education (APRE). She holds a 1/3 interest in the Slavin Sisters Farm LLC, a 119 acre farm in Walworth, WI.

Cow’s milk-based beverage consumption in 1- to 4-year-olds and allergic manifestations: an RCTM. V. Pontes, T. C. M. Ribeiro, H. Ribeiro, A. P. de Mattos, I. R. Almeida, V. M. Leal, G. N. Cabral, S. Stolz, W. Zhuang and D. M. F. Scalabrin.  Nutrition Journal. 2016;15:19.  DOI: 10.1186/s12937-016-0138-0

  • Conclusion: A cow’s milk-based beverage containing DHA, PDX/GOS, and yeast β-glucan, and supplemented with micronutrients, including zinc, vitamin A and iron, when consumed 3 times/day for 28 weeks by healthy 1- to 4-year-old children was associated with fewer episodes of allergic manifestations in the skin and the respiratory tract.
  • Funding: This study was funded by Mead Johnson Nutrition…The study products were provided by Mead Johnson Nutrition. Dr. Scalabrin, S. Stolz, and W. Zhuang work in Clinical Research, Department of Medical Affairs at Mead Johnson Nutrition. All of the remaining authors have no financial relationships to disclose.

Whole grain consumption trends and associations with body weight measures in the United States: results from the cross sectional National Health and Nutrition Examination Survey 2001–2012.  Ann M. Albertson, Marla Reicks, Nandan Joshi and Carolyn K. Gugger.  Nutrition Journal 2016;15:8.  DOI: 10.1186/s12937-016-0126-4

  • Conclusions: The data from the current study suggest that greater whole grain consumption is associated with better intakes of nutrients and healthier body weight in children and adults. Continued efforts to promote increased intake of whole grain foods are warranted.
  • Competing interests:  Marla Reicks received an unrestricted gift from the General Mills Bell Institute of Health and Nutrition during the manuscript preparation to support research at the University of Minnesota.  Carolyn Gugger and Nandan Joshi are current employees and stockholders of General Mills, Inc.  Ann Albertson was an employee of General Mills, Inc during the conception, analysis and initial preparation of the manuscript. She is currently retired from General Mills.
  • Non-financial competing interests: General Mills, Inc is a global consumer foods company that manufactures and sells products across a broad variety of food categories, including grain-based foods. General Mills product portfolio includes ready-to-eat cereals, cereal bars, baked goods, flour, and salty snacks that may contain whole grain.
Mar 4 2016

Julia Belluz (Vox) on my collection of studies sponsored by food companies

Julia Belluz of Vox has just done a story on my collection of studies funded by food companies.  Here are a few excerpts.  For the entire article and its excellent illustrations, click on the link):

About a year ago, Marion Nestle finally got sick of the rotten state of nutrition science.

Everywhere she looked, she found glaring conflicts of interest. “Without any trouble, I could identify industry-funded nutrition studies by their titles,” says the New York University professor. “It was so obvious”…But Nestle is not the first to notice this problem. Many nutrition researchers have been complaining about conflict-of-interest problems in their field for some time now. Whereas other fields, like medicine, have been putting in place safeguards to protect against undue industry influence, the field of nutrition has lagged behind in this regard.  And other research backs up Nestle’s findings. Take this review of studies on sugary drinks. Independently funded studies tend to find a correlation between soda consumption and poor health outcomes. Studies funded by soda makers, by contrast, are less likely to find such correlations. Or take this investigation of 206 publications on the health effects of milk, soft drinks, and fruit juices. Studies that were funded by beverage companies were four to eight times more likely to come to favorable conclusions about the health effects of those beverages.

The reporter interviewed researchers who work in food and nutrition about all this.

They all acknowledged that she was tapping into a real problem, one that’s been difficult for their community to address.  So why are conflicts of interest allowed to persist in nutrition research?  One root cause is the need for funding. Right now nutrition science is relatively underfunded by government, leaving lots of space for food companies and industry groups to step in and sponsor research…Tradition also plays a role. “Nutrition science has always been close to producers,” Dutch nutrition researcher Martijn Katan told me. “There’s such a direct interest in the outcomes of research for producers”…And food companies have ample incentive to promote this research. Under Food and Drug Administration rules, any health claims that they want to make on their packaging has to be backed up by scientific research. So the food industry has a keen interest in funding research — and favorable research that their profits may depend on.

She quotes Martijn Katan:

In the long term,” Katan said, “the deepest harm being done is that it undermines the credibility of science. In the short term, it means some people will eat more butter or cheese than is good for them, and that it will take longer to get people off soda.”

Her conclusion:

None of the researchers I spoke to suggested we should abolish industry funding of food and nutrition studies. As Katan has written, these collaborations can lead to fruitful discoveries…Instead, they wanted to see more awareness about the problem, more scrutiny of industry-funded research, and organized efforts to control conflicts of interest. “It’s not the quality of the science that’s at issue,” Nestle explains. “The studies are carried out according to strong scientific principles. But the bias seems to come in around the research question that’s asked, the interpretation of the results, putting a positive spin on findings even when the results are neutral.” That’s not good for science or for public health.

Mar 3 2016

More industry-funded studies with industry-favorable results. The score 140/12.

A nutrient profiling system for the (re)formulation of a global food and beverage portfolio.  Antonis Vlassopoulos · Gabriel Masset · Veronique Rheiner Charles ·Cassandra Hoover · Caroline Chesneau‑Guillemont · Fabienne Leroy ·Undine Lehmann · Jörg Spieldenner · E‑Siong Tee · Mike Gibney ·Adam Drewnowski.  Eur J Nutr DOI 0.1007/s00394-016-1161-9.

  • Conclusions:  The NNPS sets feasible and yet challenging targets for public health-oriented reformulation of a varied product portfolio; its application was associated with improved nutrient density in eight major food categories in the USA and France.
  • Funding: The research presented herein was funded by Nestec Ltd, which is a wholly owned affiliate of Nestlé S.A.  The first eight authors are employed by Nestlé.
  • Comment: the paper is the basis of a Nestlé infographic.

Including whey protein and whey permeate in ready-to-use supplementary food improves recovery rates in children with moderate acute malnutrition: a randomized, double-blind clinical trial.  Heather C Stobaugh, Kelsey N Ryan, Julie A Kennedy, Jennifer B Grise, Audrey H Crocker, Chrissie Thakwalakwa, Patricia E Litkowski, Kenneth M Maleta, Mark J Manary, and Indi Trehan.  Am J Clin Nutr  First published February 10, 2016, doi: 10.3945/​ajcn.115.124636.

  • Conclusion: This study highlights the importance of milk protein in the treatment of MAM, because the use of a novel whey RUSF resulted in higher recovery rates and improved growth than did soy RUSF [ready-to-use supplemental food], although the whey RUSF supplement provided less total protein and energy than the soy RUSF.
  • Funding for this project was provided by the Danish Dairy Research Foundation, Arla Foods Ingredients Group P/S, and the US Dairy Export Council. IT was supported by the Children’s Discovery Institute of Washington University in St. Louis and St. Louis Children’s Hospital…The funders had no role in the design or implementation of the study and no role in the analysis or interpretation of the data.

Oral health promotion: the economic benefits to the NHS of increased use of sugarfree gum in the UKL. Claxton, M. Taylor & E. Kay.  British Dental Journal 220, 121 – 127 (2016).  Published online: 12 February 2016 | doi:10.1038/sj.bdj.2016.94

  • Conclusion If all members of the UK 12-year-old population chewed SFG frequently (twice a day), the potential cost savings for the cohort over the course of one year were estimated to range from £1.2 to £3.3 million and if they chewed three times a day, £8.2 million could be saved each year…This study shows that if levels of SFG usage in the teenage population in the UK could be increased, substantial cost savings might be achieved.
  • Declaration: This study and writing support for the manuscript were funded by Wrigley Oral Healthcare Programme.

Dietary carbohydrate restriction as the first approach in diabetes management: Critical review and evidence base Richard D. Feinman, Wendy K. Pogozelski , Arne Astrup M.D., Richard K. Bernstein M.D., Eugene J. Fine M.S., M.D. , Eric C. Westman M.D., M.H.S.  , Anthony Accurso M.D. , Lynda Frassetto M.D.  , Barbara A. Gower Ph.D.  , Samy I. McFarlane M.D.  , Jörgen Vesti Nielsen M.D.  , Thure Krarup M.D. , Laura Saslow Ph.D. , Karl S. Roth M.D. , Mary C. Vernon M.D. , Jeff S. Volek R.D., Ph.D. , Gilbert B. Wilshire M.D. , Annika Dahlqvist M.D.r , Ralf Sundberg M.D., Ph.D.  , Ann Childers M.D.  , Katharine Morrison M.R.C.G.P.  , Anssi H. Manninen M.H.S.  , Hussain M. Dashti M.D., Ph.D., F.A.C.S.,  F.I.C.S., Richard J. Wood Ph.D., Jay Wortman M.D. , Nicolai Worm Ph.D.  Nutrition. January 2015 Volume 31, Issue 1, Pages 1–13 DOI: http://dx.doi.org/10.1016/j.nut.2014.06.011

  • Conclusion: Here we present 12 points of evidence supporting the use of low-carbohydrate diets as the first approach to treating type 2 diabetes and as the most effective adjunct to pharmacology in type 1.
  • Disclosure: AA is consultant/member of advisory boards for the Dutch Beer Knowledge Institute, NL, Global Dairy Platform, USA, Jenny Craig, USA, McCain Foods Limited, USA, McDonald’s, USA, and Gerson Lehrman Group, USA (ad hoc consultant for clients). He is recipient of honoraria and travel grants as speaker for a wide range of Danish and international concerns. He has conducted research funded by a number of organizations with interests in the food production and marketing sector. RDF writes reviews for Fleishman-Hillard, whose client is the Corn Refiners Association and he has received grant support from the Veronica and Robert C. Atkins Foundation. EJF has received grant support from the Veronica and Robert C. Atkins Foundation. TK sits on an advisory board for Eli Lilly and gives lectures for Lilly about the diabetic diet. NW has written popular-audience books on low-carbohydrate diets and is a consultant and promoter for Leberfasten/Hepafast, a specific low-carbohydrate meal replacement program. JW is on the Scientific Advisory Board of Atkins Nutritionals Inc. with paid retainer, honoraria, and travel costs. None of the other authors have anything to declare.
  • Comment: The Atkins Diet is low-carbohydrate.

Comparison of Commercial and Self-Initiated Weight Loss Programs in People With Prediabetes: A Randomized Control Trial David G. Marrero, PhD, Kelly N. B. Palmer, MHS, Erin O. Phillips, BA, Karen Miller-Kovach, EBMA, MS, Gary D. Foster, PhD, and Chandan K. Saha, PhD. Am J Public Health. Published online ahead of print February 18, 2016: e1–e8. doi:10.2105/AJPH.2015.303035

  • Conclusions. A large weight-management program is effective for achieving lifestyle changes associated with diabetes prevention. Such programs could significantly increase the availability of diabetes prevention programs worldwide making an immediate and significant public health impact.
  • Funding: This study was funded by Weight Watchers International.

It’s close to a year since I first started collecting these studies.  When the year is up, I will do some analysis.  Until then, the bottom line is that it’s easier to find industry-funded studies with results favorable to the sponsor than it is to find those that are not.

Feb 26 2016

Corrections to the list of industry-funded studies: the count is again 135/12.

Readers have filed corrections to previous postings on industry-funded studies (see here and here).  I am most grateful for their sharp eyes.  No excuses, but I’m having a hard time keeping them straight because there are so many, some are published first online and then again in print, and sometimes I just get them wrong.  Apologies.

The corrections reduce the count to 132/12.  But here are three more to bring it back up to 135/12.

Management of obesity.  George A Bray, Gema Frühbeck, Donna H Ryan, John P H Wilding.  The Lancet.  Published online February 8, 2016 http://dx.doi.org/10.1016/S0140-6736(16)00271-3.

  • Conclusion: For patients who struggle with weight loss and who would receive health benefit from weight loss, management of medications that are contributing to weight gain and use of approved medications for chronic weight management along with lifestyle changes are appropriate. Medications approved in the USA or European Union are orlistat, naltrexone/bupropion, and liraglutide; in the USA, lorcaserin and phentermine/topiramate are also available. Surgical management (gastric banding, sleeve gastrectomy, and Roux-en Y gastric bypass) can produce remarkable health improvement and reduce mortality for patients with severe obesity.
  • Declaration of interests GAB is a consultant to Herbalife International and Medifast; a member of the Speakers Bureau for Novo Nordisk Pharmaceuticals and Takeda Pharmaceuticals; and receives royalties from Up-to-Date and Handbook of Obesity. GF is a consultant to Novo Nordisk Pharmaceuticals. DHR is a consultant to Novo Nordisk Pharmaceuticals, Takeda Pharmaceuticals, Eisai Pharmaceuticals, Vivus Pharmaceuticals, Janssen Pharmaceuticals, Amgen Pharmaceuticals, Real Appeal, Gila Therapeutics, Tulip Medical, and Scientific Intake; is on the speakers’ bureau for Novo Nordisk Pharmaceuticals, Takeda Pharmaceuticals, Eisai Pharmaceuticals, and Vivus Pharmaceuticals; and has equity ownership in Scientifi c Intake. JPHW received grant funding from Novo Nordisk and AstraZeneca, and is a consultant to Novo Nordisk, Janssen Pharmaceuticals, AstraZeneca Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, and Pfi zer Pharmaceuticals.

The effects of potatoes and other carbohydrate side dishes consumed with meat on food intake, glycemia and satiety response in children.  R Akilen, N Deljoomanesh, S Hunschede, CE Smith, MU Arshad, R Kubant and GH Anderson.  Nutrition & Diabetes (2016) 6, e195; doi:10.1038/nutd.2016.1

  • Conclusions: The physiological functions of CHO foods consumed ad libitum at meal time on food intake, appetite, BG, insulin and gut hormone responses in children is not predicted by the GI [glycemic index].
  • Acknowledgements: This study was supported by the Alliance for Potato Research and Education (APRE).
  • Comment: David Ludwig, M.D., PhD says: “Potatoes are at the top of the list for weight gain according to the best epidemiological research studies. A small new study claimed that potatoes actually had beneficial effects on appetite. There’s just one thing: The study was fully funded by the Alliance for Potato Research and Education, whose mission is to ‘recognize the role of all forms of the potato in promoting health for all age groups.’”  Here’s the press release from the Alliance for Potato Research & Education.

Nutrient Intakes and Vegetable and White Potato Consumption by Children Aged 1 to 3 Years.  Maureen L Storey and Patricia A Anderson.  doi: 10.3945/​an.115.008656.  Adv Nutr January 2016 Adv Nutr vol. 7: 241S-246S, 2016.

  • Conclusion: The consumption of all vegetables, particularly those that are excellent sources of potassium and DF, such as potatoes, should be encouraged.
  • Funding: Presented at the Roundtable on Science and Policy: Adopting a Fruitful Vegetable Encounter for Our Children. The roundtable was sponsored by the USDA/Agricultural Research Service Children’s Nutrition Research Center, Baylor College of Medicine, and was held in Chicago, IL, 10–11 November 2014. The roundtable and supplement publication were supported by an unrestricted grant from the Alliance for Potato Research and Education. The roundtable speakers received travel funding and an honorarium for participation in the meeting and manuscript preparation. Author disclosures: ML Storey is a paid employee of the Alliance for Potato Research and Education; PA Anderson is a paid consultant for the Alliance for Potato Research and Education.
  • Comment: Potato trade associations must be really worried about views like those of Dr. Ludwig.  Personally, I love potatoes and think they are delicious but should be eaten in moderation of course, and not in the form of French fries.  Speculation: I wonder if frequent consumption of French fries could be a marker of unhealthful diets in general?
Feb 23 2016

More industry-funded studies. The score: 135/12. Correction: 132/12.

Corrections, February 25:  Several readers have written in to comment that two of these papers do not actually appear to benefit the sponsors.  I have written their comments in red.  A reader also filed a correction to one of listings for February 18.  That brings the score down to 132/12.

It’s been 11 months since I started collecting studies funded by food companies with results favorable to the company’s marketing interests.  I’ve now found 135 such studies versus just 12 with results unfavorable.

When the year is up, I will do an overall interpretation of what this collection does and does not signify, but for the moment I will just state the obvious: it is easier to find industry-funded studies with favorable rather than unfavorable results.

Enjoy this week’s collection.

Latin American Study of Nutrition and Health (ELANS): rationale and study design. M. Fisberg, I. Kovalskys, G. Gómez, A. Rigotti, L. Y. Cortés, M. Herrera-Cuenca, M. C. Yépez, R. G. Pareja,Guajardo, I. Z. Zimberg, A. D. P. Chiavegatto Filho, M. Pratt, B. Koletzko, K. L. Tucker and the ELANS Study Group. BMC Public Health (2016) 16:93.  DOI 10.1186/s12889-016-2765-y.

  • Conclusion: This study will provide valuable information and a unique dataset regarding Latin America that will enable cross-country comparisons of nutritional statuses that focus on energy and macro- and micronutrient intakes, food patterns, and energy expenditure.
  • Funding: The ELANS study and authors were partially supported by a scientific grant from the Coca Cola Company and by different grants and support from the Instituto Pensi/Hospital Infantil Sabara, International Life Science Institute of Argentina, Universidad de Costa Rica, Pontificia Universidad Católica de Chile, Pontificia Universidad Javeriana, Universidad Central de Venezuela (CENDESUCV)/Fundación Bengoa, Universidad San Francisco de Quito, and Instituto de Investigación Nutricional de Peru. The funders had no role in study design, data collection and analysis, the decision to publish, or the preparation of this manuscript. KLT received consulting fees from the Coca Cola Company to participate. MF is member of the directory of Danone Institute International.
  • A reader writes: Coca-Cola undoubtedly hopes that this study will support their efforts to put the blame on lack of exercise. However, the present paper gives no data, and the design does not seem biased. I do not think this paper can support marketing of Coca-Cola.  My response: OK.  Let’s call this one neutral and delete it from the list.

Biofortified yellow cassava and vitamin A status of Kenyan children: a randomized contr.  Am J Clin Nutr 2016; 103:258-267 doi:10.3945/ajcn.114.100164

  • Conclusion: In our study population, consumption of yellow cassava led to modest gains in serum retinol concentration and a large increase in β-carotene concentration. It can be an efficacious, new approach to improve vitamin A status.
  • Funding: Supported by the European Union’s Seventh Framework Programme (FP7/2007-2013) under grant agreement 211484, conducted within the framework of INSTAPA Project. HarvestPlus provided financial support for biochemical analyses and supplies. Capsugel (Bornem, Belgium), Laboratory&Allied (Nairobi, Kenya), DSM Nutritional Products/Sight and Life (Basel, Switzerland), and Laboratorium Medisan (Heerenveen, Netherlands) provided financial and technical support in producing supplements…None of the authors reported a conflict of interest. The funders had no role in the design, implementation, analysis, or interpretation of the data.
  • A reader writes: This study came out somewhat favorably for yellow cassava (non-GMO) and thus for HarvestPlus, but HarvestPlus is a charity with no commercial interests. DSM company provided the carotene capsules for the positive control group, but the study shows you might as well eat cassava naturally high in carotene instead of capsules.  My response: This one is not industry-funded.  Delete from list.

Effects of Diet Composition and Insulin Resistance Status on Plasma Lipid Levels in a Weight Loss Intervention in Women.Tran Le, BA; Shirley W. Flatt, MS; Loki Natarajan, PhD; Bilge Pakiz, EdD; Elizabeth L. Quintana, MS, RD Dennis D. Heath, MS1; Brinda K. Rana, PhD; Cheryl L. Rock, PhD, RD.  J Am Heart Assoc.2016; 5: e002771.  Originally published January 25, 2016.  doi: 10.1161/JAHA.115.002771.

  • Conclusions Weight loss was similar across the diet groups, although insulin‐sensitive women lost more weight with a lower fat, higher carbohydrate diet versus a higher fat, lower carbohydrate diet. The walnut‐rich, higher fat diet resulted in the most favorable changes in lipid levels.
  • Funding: This study was supported by the NIH (CA155435) and the California Walnut Commission.

Regular Fat and Reduced Fat Dairy Products Show Similar Associations with Markers of Adolescent Cardiometabolic Health. Therese A. O’Sullivan, Alexandra P. Bremner, Trevor A. Mori, Lawrence J. Beilin, Charlotte Wilson, Katherine Hafekost, Gina L. Ambrosini, Rae Chi Huang and Wendy H. Oddy.   Nutrients 2016, 8(1), 22; doi:10.3390/nu8010022.

  • Conclusions: Although regular fat dairy was associated with a slightly better cholesterol profile in boys, overall, intakes of both regular fat and reduced fat dairy products were associated with similar cardiometabolic associations in adolescents.
  • Funding: Therese A. O’Sullivan received a grant from The Dairy Health and Nutrition Consortium Australia (DHNC-MetX06-2011) which provided funding for the analysis and write up of this study. No other authors declare a conflict of interest.

Concord grape juice, cognitive function, and driving performance: a 12-wk, placebo-controlled, randomized crossover trial in mothers of preteen children. Daniel J Lamport, Clare L Lawton, Natasha Merat, Hamish Jamson, Kyriaki Myrissa, Denise Hofman, Helen K Chadwick, Frits Quadt, JoLynne D Wightman, and Louise Dye. AJCN. First published ahead of print February 10, 2016 as doi: 10.3945/ajcn.115.114553.

  • Conclusions: Cognitive benefits associated with the long-term consumption of flavonoid-rich grape juice are not exclusive to adults with mild cognitive impairment. Moreover, these cognitive benefits are apparent in complex everyday tasks such as driving. Effects may persist beyond the cessation of flavonoid consumption….
  • Funding:  Supported by Welch Foods Inc…. JDW is an employee of Welch Foods Inc. None of the other authors reported a conflict of interest.
  • Comment: Welch sent out a press release: “New research by the University of Leeds in the UK suggests that drinking Concord grape juice daily can benefit certain aspects of memory and everyday tasks in people with stressful lifestyles – specifically working mothers.”  Yoni Freedhoff has additional comments on Weighty Matters:Welch’s Study Finds Grape Juice Makes You Smarter #NotTheOnion.
Feb 18 2016

The collection continues: 5 more funded studies with results favoring the sponsor. The score: 130/12. Correction: 129/12.

Correction: February 24.  A reader points out that one of the studies posted here had already been posted on January 27  as an industry-negative.  Apologies.  Consider it deleted and change the count.

Yesterday’s post was about a study funded by Disney.  It brought the number of studies funded by companies with results favorable to the company to 125 since last March.  I’ve only found 12 with unfavorable results.  Today’s five raise the count to 130/12.

The association between dietary saturated fatty acids and ischemic heart disease depends on the type and source of fatty acid in the European Prospective Investigation into Cancer and Nutrition–Netherlands cohortJaike Praagman, Joline WJ Beulens, Marjan Alssema, Peter L Zock, Anne J Wanders, Ivonne Sluijs, and Yvonne T van der Schouw. Am J Clin Nutr 2016; 103:356-365 doi:10.3945/ajcn.115.122671.  I posted this study as industry-negative on January 27; it is listed here in error.  

Dietary plant stanol ester consumption improves immune function in asthma patients: results of a randomized, double-blind clinical trial.  Florence Brüll, Els De Smet, Ronald P Mensink, Anita Vreugdenhil, Anja Kerksiek, Dieter Lütjohann, Geertjan Wesseling, and Jogchum Plat. Am J Clin Nutr 2016; 103:444-453 doi:10.3945/ajcn.115.117531

  • Conclusion: To the best of our knowledge, we are among the first authors to show that plant stanol ester consumption improves the immune function in vivo in asthma patients
  • Supported by RAISIO Nutrition LTD. Test products for the study were provided by RAISIO Nutrition LTD…RAISIO Nutrition LTD is a Finnish food company that is involved in life sciences and sells, among other products, the Benecol brand. RAISIO Nutrition LTD had no influence in the setup of the study or the interpretation of the results. None of the authors reported a conflict of interest related to the study.

Low Calorie Beverage Consumption Is Associated with Energy and Nutrient Intakes and Diet Quality in British Adults.  Sigrid A. Gibson, GrahamW. Horgan, Lucy E. Francis, Amelia A. Gibson and Alison M. Stephen.  Nutrients 2016, 8(1), 9; doi:10.3390/nu8010009

  • Conclusion: Results indicate that NC and LCB consumers tend to have higher quality diets compared with SSB or BB consumers and do not compensate for sugar or energy deficits by consuming more sugary foods.
  • Conflicts of Interest: S.G. is director of Sig-Nurture Ltd, an independent consultancy, which has received research funding from food and beverage and ingredient companies, not-for-profit organisations and trade bodies. None of the other authors had a conflict of interest. The sponsors had no role in the design, analysis or interpretation of the study, or in the preparation of the manuscript

Dietary Milk-Fat-Globule Membrane Affects Resistance to Diarrheagenic Escherichia coli in Healthy Adults in a Randomized, Placebo-Controlled, Double-Blind StudySandra J Ten Bruggencate3,*, Pernille D Frederiksen4, Simon M Pedersen5, Esther G Floris-Vollenbroek3, Elly Lucas-van de Bos3, Els van Hoffen3, and Peter L Wejse5.  J. Nutr. February 1, 2016  vol. 146 no. 2 249-255

  • Conclusion: The present diarrheagenic E. coli challenge trial conducted in healthy adults indicates that a milk concentrate rich in natural, bioactive phospho- and sphingolipids from the MFGM may improve in vivo resistance to diarrheagenic E. coli.
  • Author disclosures: SJ Ten Bruggencate, EG Floris-Vollenbroek, E Lucas-van de Bos, and E van Hoffen, no conflicts of interest. PD Frederiksen is an employee of Arla Foods Ingredients Group P/S (AFI, Denmark), which produces and markets Lacprodan MFGM-10, Lacprodan PL-20, and Capolac MM 0525 BG. SM Pedersen and PL Wejse are employees of Arla Foods amba (Denmark). The sponsor was involved in the writing of the manuscript.
  • Comment:  This is the first time I’ve seen a disclosure of the sponsor’s involvement in the writing of a manuscript.  High marks to the Journal of Nutrition for insisting on this.

A 9-mo randomized clinical trial comparing fat-substituted and fat-reduced diets in healthy obese men: the Ole Study.  George A Bray, Jennifer C Lovejoy, Marlene Most-Windhauser, Steven R Smith, Julia Volaufova, Yvonne Denkins, Lilian de Jonge, Jennifer Rood, Michael Lefevre, Alison L Eldridge, and John C Peters.   Am J Clin Nutr 2002;76: 928–34.

  • Conclusion: Replacement of dietary fat with olestra reduces body weight and total body fat when compared with a 25%-fat diet or a control diet containing 33% fat.
  • Supported in part by…the USDA and by the Procter & Gamble Co, Cincinnati.
Feb 12 2016

Five more studies related to food-industry sponsorship. The score: 124/12

I’m having a hard time keeping up with these, but here are five more industry-funded studies with results favorable to the sponsor, bringing the total of industry-positives to 124 since last March, versus just 12 with unfavorable results.  This percentage is lower than that found in more systematic studies.  If you know of such studies, please send.

In the meantime, here’s the next set.

A randomized controlled trial to determine the efficacy of a high carbohydrate and high protein ready-to-eat food product for weight loss.  N. R. Fuller, M. Fong, J. Gerofi, L. Leung, C. Leung, G. Denyer andI. D. Caterson.  Clinical Obesity. Article first published online: 19 JAN 2016. DOI: 10.1111/cob.12137

  • Conclusion: There was no significant difference in percentage weight loss from screening to 6 weeks between the two groups…Both diets were nutritionally matched and well-accepted over the 6-week period. This study shows that the inclusion of a ready-to-eat food product can be included as part of a dietary programme to achieve a clinically significant weight loss over a short period.
  • Funding: This study was supported by a research grant from Arnotts Biscuits Ltd. The funder had no role in the protocol design, the conduct of the study, the analysis of the data, nor the writing of the manuscript.
  • Comment: The idea of this study was to get participants to include Vita-Weat biscuits in their diets.  The control group was simply advised about healthy eating.  Both groups lost weight.  Arnotts Biscuits makes Vita-Weat.

Obesity, Fitness, Hypertension, and Prognosis: Is Physical Activity the Common Denominator?  Carl J. Lavie, MD, Parham Parto, MD; Edward Archer, PhD. JAMA Intern Med. 2016;176(2):217-218. doi:10.1001/jamainternmed.2015.7571.

  • Conclusions: Although excess caloric load has been suggested as a major contributor to obesity, we believe that marked declines during the past 5 decades in leisure time and occupational physical activity explain the notable increase in BMI over time… Therefore, substantial efforts are needed, beginning in children and adolescents and extending into adulthood, to increase levels of physical activity across all ages and in both sexes, which would have substantial effects on preventing obesity and improving levels of CRF [cardiorespiriatory fitness].
  • Conflict of Interest Disclosures: Dr Lavie reported being the author of the book The Obesity Paradox and serving as a lecturer for the Coca Cola Company (on physical activity, exercise, fitness, and the obesity paradox and not on their products). Dr Archer reported received speaking fees from industry and nonprofit organizations.
  • Comment: Coca-Cola has been especially active in funding investigators who promote the idea that physical activity is more important that diet in determining health status.  This paper is a commentary on a study demonstrating that “high BMI and low aerobic capacity in late adolescence were associated with higher risk of hypertension in adulthood…interventions to prevent hypertension should begin early in life and include not only weight control but aerobic fitness, even among persons with normal BMI.”

Dietary anthocyanin intake and age-related decline in lung function: longitudinal findings from the VA Normative Aging Study.  Amar J Mehta,, Aedín Cassidy, Augusto A Litonjua, David Sparrow, Pantel Vokonas, and Joel Schwartz.  Am J Clin Nutr February 2016 vol. 103 no. 2 542-550

  • Conclusions: An attenuation of age-related lung function decline was associated with higher dietary anthocyanin intake in this longitudinal sample of predominantly elderly men. Further prospective studies are needed to confirm these novel associations.
  • Conflicts: AC has a grant, unrelated to this project, to conduct observational and experimental studies of blueberries and cardiovascular health outcomes from the US Highbush Blueberry Council. None of the other authors had competing interests to declare.
  • Comment:  This paper is about blueberry anthocyanins.  The authors report “Blueberry intake was associated with the slowest rate of annual decline in lung function; compared with no or very low intake.”

The effects of lutein on cardiometabolic health across the life course: a systematic review and meta-analysis.  Elisabeth TM Leermakers, Sirwan KL Darweesh, Cristina P Baena, Eduardo M Moreira, Debora Melo van Lent, Myrte J Tielemans, Taulant Muka, Anna Vitezova, Rajiv Chowdhury, Wichor M Bramer, Jessica C Kiefte-de Jong, Janine F Felix, and Oscar H Franco.  Am J Clin Nutr February 2016 vol. 103 no. 2 481-494

  • Conclusions: Our findings suggest that higher dietary intake and higher blood concentrations of lutein are generally associated with better cardiometabolic health. However, evidence mainly comes from observational studies in adults, whereas large-scale intervention studies and studies of lutein during pregnancy and childhood are scarce.
  • Funding: ETML, DMvL, MJT, JCK-dJ, and OHF are employees at ErasmusAGE, a center for aging research across the life course funded by Nestlé Nutrition (Nestec Ltd.), Metagenics Inc., and AXA. Nestlé Nutrition (Nestec Ltd.), Metagenics Inc., and AXA had no role in the design or conduct of the study; the collection, management, analysis, or interpretation of the data; or the preparation, review, or approval of the manuscript. None of the authors reported a conflict of interest related to the study.

Dietary protein intake is associated with body mass index and weight up to 5 y of age in a prospective cohort of twins.  Laura Pimpin, Susan Jebb, Laura Johnson, Jane Wardle, and Gina L Ambrosini.  First published December 30, 2015, doi: 10.3945/​ajcn.115.118612.  Am J Clin Nutr February 2016 vol. 103 no. 2 389-397

  • Conclusion: A higher proportion of energy from protein during the complementary feeding stage is associated with greater increases in weight and BMI in early childhood in this large cohort of United Kingdom children.
  • Conflicts: JW: was principal investigator of the Gemini study with responsibility for data collection; and all authors: advised on the analyses or interpretation of data and contributed to manuscript preparation. JW received grants from Cancer Research UK and from Danone Baby Nutrition during the conduct of the study. LJ received institutional consultancy fees from Danone Baby Nutrition during the conduct of the study. All other authors declared no conflicts of interest.
Feb 11 2016

A rare industry-negative study brings the score to 119/12

Short-term studies of DHA ( docosahexaenoic acid, a long-chain omega-3 fatty acid) have suggested that DHA supplements promote the visual acuity of infants born prematurely.  This study, for which supplement and formula companies donated products, and in which some of the investigators had connections to those and other companies with a vested interest in the results, could not find measurable benefits of DHA supplementation by the time children reached school age.

This is a rare example of a study supported by food companies with results that must have caused much disappointment.

How rare?  Since last March, I’ve unsystematically collected 119 industry-supported studies with results that favor the sponsor’s interest (industry-positive) but have only run across or been sent 12 that do not.

Long-term effect of high-dose supplementation with DHA on visual function at school age in children born at 33 wk gestational age: results from a follow up of a randomized controlled trial. Carly S Molloy, Sacha Stokes, Maria Makrides, Carmel T Collins, Peter J Anderson, and Lex W Doyle.  Am J Clin Nutr 2016; 103:268-275 doi:10.3945/ajcn.115.114710.

  • Conclusion: Supplementing human milk with DHA at a dose of ~1% of total fatty acids given in the first months of life to very preterm infants does not appear to confer any long-term benefit for visual processing at school age.
  • Funding: Treatment and placebo capsules for the original trial were donated by Clover Corporation, and infant formula was donated by Mead Johnson Nutrition and Nutricia Australasia.
  • Authors’ disclosures: CTC and MM have received nonfinancial support from Clover Corporation and Nestlé Nutrition for research outside that of the submitted work. MM serves on scientific advisory boards for Nestlé, Fonterra, and Nutricia. Associated honoraria for MM are paid to her institutions to support conference travel and continuing education for postgraduate students and early-career researchers. MM, through the Women’s and Children’s Health Research Institute, has a patent pending “Methods and compositions for promoting the neurological development of an infant.” None of the other authors declared a conflict of interest.
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