by Marion Nestle

Currently browsing posts about: Sponsored-research

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 17 2016

The strange story of my accepted but then unpublished commentary on a Disney-sponsored study

Last summer, Brian Wansink, a friend and Cornell colleague and the editor of the new Journal of the Association for Consumer Research, asked me to write a commentary on a paper to be published in its inaugural issue.

The paper turned out to be by a group of authors, among them John Peters and Jim Hill, both members of the ill-fated Global Energy Balance Network, the subject of an investigation by the New York Times last August.

Titled “Using Healthy Defaults in Walt Disney World Restaurants to Improve Nutritional Choices,” the paper described the benefits of improving the composition of kids’ meals at Disney World.

The healthy defaults reduced calories (21.4%), fat (43.9%) and sodium (43.4%) for kid’s meal sides and beverages sold in the park. These results suggest that healthy defaults can effectively shift food and beverage selection patterns toward healthier options.

The authors explain:

This work was supported by the Walt Disney Company and by the National Institutes of Health…The Walt Disney Company and the National Institutes of Health had no role in the design, analysis, or writing of this article. Full disclosure: JH is a consultant for the Walt Disney Company and for McDonalds; KA is a consultant for the Walt Disney Company.”

I thought Disney’s sponsorship of this research and its withholding of critical baseline and sales data on kids’ meals that the company considered proprietary did indeed deserve comment, and wrote my piece accordingly.  Brian Wansink soon accepted it for publication but to my surprise, gave it to Peters et al. for rebuttal.  They filed a lengthy response.  I was then given the opportunity to respond, and did so, briefly.

The paper by Peters, et al. did was published in the journal’s first issue.   This issue also includes several commentaries on other papers (none of which are accompanied by rebuttals).

My commentary—and the back-and-forth—however, were omitted.

After some discussion, the journal published my commentary online.  You have to scroll down to find it.  The site provides no links to it in the table of contents or in the article by Peters et al.

Is it possible that Disney or the authors’ contractual relationships with Disney could have had anything to do with the omission of my accepted-for-publication commentary?  Brian Wansink says no, they just ran out of room (despite room for others).

Whatever.

Here’s what I wrote:

Dietary nudges for obesity prevention: They work, but additional policies are also needed

In 2006, the Walt Disney Company announced a new initiative to improve the nutritional quality of meals served to children at its theme parks. The company would be changing the default kids’ meals—the components that come without having to be ordered separately–to include low-fat milk, juice, or water rather than soft drinks, and sides such as apple sauce or carrots rather than French fries. Parents who wanted sodas or fries for their children would have to ask for them, something many might not bother to do. Health groups had long advocated for this policy change (Wootan 2012).

As I commented to a reporter at the time, “going to Disney World is an excuse for eating junk food…Disney or its advisers must be feeling they have some responsibility” (Horovitz and Petrecca 2006). Indeed, the healthier defaults were part of a larger effort by Disney to deal with its contribution to obesity in America. After ticket prices, food is the second greatest source of revenue at Disney World. Although reducing the amount of food consumed at the parks might help create a less “obesogenic” food environment, revenues might fall. But the default change might be revenue neutral. By 2008, Disney could report that two-thirds of U.S. customers ordering kids’ meals had accepted the default, with no loss in sales. In Hong Kong Disney parks, nearly all customers accepted the default. The report, however, did not include data on the numbers or proportions of customers ordering kids’ meals (Walt Disney Company 2008).

Disney’s more recent summary of its child health initiatives states that it is funding investigators at the University of Colorado to conduct a more formal evaluation of use of the default options (Walt Disney Company 2015). The paper by Peters et al. (2016) in this issue of the Journal presents the results of that research. Their work confirms the ongoing effectiveness of the strategy. Nearly half the customers ordering kids’ meals accepted the healthy default side dishes and two-thirds accepted the healthier beverages. These choices resulted in significant reductions in the calories, fat, and sodium in purchased kids’ meals, but not sugar (Peters et al 2016).

The authors argue that gentle nudges changes like these are preferable to more coercive policies that smack of nanny statism. Such reductions help, but are they enough to make a real difference? To answer this question, it would help to know what else the children were eating along with the drink and side dishes. Although the authors were given raw sales data, Disney did not permit them to use this information as part of the overall analysis. The company also refused to provide information about the number of children who visited the park or the number of kids’ meals sold.

These missing pieces raise red flags because this is a Disney-funded study that produced results that Disney can use to advertise itself as a company that cares about kids’ health, and to deflect attention from Disney World’s’ reputation as a junk-food paradise. Corporate funding of research introduces conflicts of interest and reduces the credibility of the results, not least because the biases inherent in such research are largely unconscious, unintentional, and unrecognized (Moore et al 2005) The results of this study merit especially careful scrutiny. Taking them at face value, the default strategy worked well for the drink, but the sides are still a problem, and so are the sugars. They do not reveal much about what kids eat in a day at Walt Disney World

Nudges like this default are an important part of strategies to counter childhood obesity. But are they enough to deal with the public health problem? To make a real difference, they need to be accompanied and supported by a range of policy approaches. Current thinking about such approaches recommends combining insights from behavioral research, economics, and public health to establish a food environment far more conducive to making the healthy choice not only easy choice, but also the preferred choice. Doing so is likely to require multiple actions—for example, regulation of nutrient content and marketing; incentives such as subsidies of healthier foods; disincentives such as taxes, warning labels, and nutritional rating systems for unhealthier foods; and education of adults and children (Hawkes et al 2015). Disney’s voluntary default is a small step in the direction of such policies, but many more are needed if we are to make real progress in reducing the prevalence of childhood obesity.

  • Margo G. Wootan. Children’s meals in restaurants: families need more help to make healthy choices.   Childhood Obesity 2012;8(1):31-33.
  • Bruce Horovitz and Laura Petrecca.  Disney to make food healthier for kids.  USA Today, October 17, 2006.
  • Walt Disney Company. Walt Disney Company—2008 Corporate Responsibility Report. 2008.
  • Walt Disney Company.  Magic of Healthy Living brochure.  2015. https://thewaltdisneycompany.com/sites/default/files/MOHL_Brochure.pdf.
  • John C. Peters, Jimikaye Beck, Jan Lande, Zhaoxing Pan, Michelle Cardel, Keith Ayoob, and James Hill. Using healthy defaults in Walt Disney World restaurants to improve nutritional choices.  J Assoc Consumer Res., 2016;1:1.
  • Don A. Moore, Daylian M. Cain, George Loewenstein, and Max H. Bazerman, editors.  Conflicts of Interest: Challenges and Solutions in Business, Law, Medicine, and Public Policy.  Cambridge University Press, 2005.
  • Corinna Hawkes, Trenton G Smith, Jo Jewell, Jane Wardle, Ross A Hammond, Sharon Friel, Anne Marie Thow, Juliana Kain.  Smart food policies for obesity prevention. The Lancet 2015;385:2410–2421.

And here’s my response to the rebuttal by Peters et al.

The response from Peters and Hill still fails to acknowledge the severity of the problems posed by Disney’s sponsorship of their research—the company’s failure to produce data essential for proper interpretation of study results, and the level to which sponsorship by food companies biases such interpretations.  At one point, Disney boasted of the results of this research, confirming its benefit to marketing goals.  The threat of industry sponsorship to research credibility has received considerable press attention in recent months, as must surely be known to these authors.1,2 

1  Anahad O’Connor.  Coca-Cola funds scientists who shift blame for obesity away from bad diets.  New York Times, August 9, 2015. http://well.blogs.nytimes.com/2015/08/09/coca-cola-funds-scientists-who-shift-blame-for-obesity-away-from-bad-diets/

2  Candice Choi.  AP Newsbreak: Emails reveal Coke’s role in anti-obesity group.  US News, November 24, 2015.  http://www.usnews.com/news/business/articles/2015/11/24/apnewsbreak-emails-reveal-cokes-role-in-anti-obesity-group

Feb 16 2016

Sponsored research Down Under: alcohol and violence

Thanks to my friend Jocelyn Harris of Dunedin, New Zealand for forwarding this editorial from the Otago Daily Times of January 16.

The editorial notes that a recent report finding no linkage between alcohol consumption and violence among Australians and New Zealanders was sponsored by Lion, a leading supplier of alcoholic beverages.

The report is Understanding Behavior in the Australian and New Zealand Night-Time Economies: An Anthropological Study.  Its author, anthropologist Anne Fox, lists these key findings:

  • Alcohol-related violence is just one aspect of a culture of violence.
  • There is no direct relationship between per capita levels of consumption and rates of violence.
  • A drinking culture is both a part of and a reflection of the culture as a whole.
  • Efforts at alcohol control will be ineffective if not related to changes in the macho culture of violence.
  • Scapegoating alcohol as the sole cause of violence merely diverts attention from violent men and the maladaptive cultural norms that allow their behaviour to develop and proliferate.

Her recommendations focus on the behavior of individuals behavior.  They largely dismiss the value of approaches such as limitations on alcohol marketing, the times alcoholic beverages can be sold, or the ways beverage companies create local cultures of drinking.

In a nutshell, the central point of this whitepaper is: it is the wider culture that determines the drinking behaviour, not the drinking. You can’t change a culture by simply changing drinking. It is, of course, justifiable to explore the effectiveness of small measures such as advertising restrictions, increases or decreases in price, relaxation or restriction of hours, but such things tinker at the margins of culture and it is doubtful that they will alter the culture of violence and anti-social behaviour in any meaningful way.

The report explains:

We could become totalitarian and try to stop public festive drinking completely, but it would most likely just move into homes. Or we can live with it and try to determine what the worst outcomes are (police overtime, all night transport cost, lost work hours and productivity, accidents and injuries, street clean-up, etc.,), and work to minimise and deal with them sensibly. We would do better to work cooperatively with all stakeholders to engineer conditions for festive drinking that are the least conducive to violence and anti-social behaviour.

In other words, societies should fix the problem at the level of “festive” drinking, but should not bother to try to prevent it at an earlier stage in the chain of causation of alcohol abuse.

The Otago Daily Times editorial concludes:

It is vital we keep debating the issues, examining the causes and hearing all the voices in the debate.

But that debate must be fair and honest.

It is a real shame, therefore, that Dr Fox has effectively silenced herself by aligning herself with an alcohol industry giant when her findings could have made a valuable contribution had they been genuinely independent.

Presumably, Lion got the report it paid for.  But it left itself—and the author’s work—vulnerable to charges of bias, an inevitable hazard of industry-sponsored research.

A shame indeed.

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.
Feb 10 2016

The American Society for Nutrition appoints Advisory Committee on Trust in Nutrition Science

I am a long-standing member of the American Society of Nutrition (ASN), and have been troubled for years by its cozy financial relationships with food companies (see, for example, this post from 2009 and the response from ASN).

ASN’s members are nutrition researchers.  The Society publishes the American Journal of Clinical Nutrition, the Journal of Nutrition, and Advances in Nutrition, sources of many of the industry-funded research articles I post regularly on this site.

ASN’s financial ties to food companies were the subject of an investigative report by Michele Simon last year: “Nutrition Scientists on the Take from Big Food: Has the American Society for Nutrition Lost All Credibility?

I am delighted to report that the ASN has now responded to these concerns, and in an especially constructive way.

The Society has just announced appointment of an Advisory Committee on Trust in Nutrition Science.

The Advisory Committee is charged with identifying best practices to allow effective collaborations while ensuring that ASN’s activities are transparent, advance research, and maintain scientific rigor; engendering trust among all nutrition science stakeholders…“Maintaining trust among all constituencies and stakeholders is paramount in ensuring that ASN and its membership are effective in carrying out ASN’s mission, to develop and extend the knowledge of nutrition through fundamental, multidisciplinary, and clinical research.” said ASN President Dr. Patrick Stover.

I’m even more delighted by the membership of this truly distinguished committee.  Whatever this group decides ought to carry a lot of weight.

Here’s the committee:

  • Cutberto Garza, MD, PhD, University Professor, Boston College, (Chair)
  • Vinita Bali, Chair, Board of Directors, Global Alliance for Improved Nutrition
  • Catherine Bertini, Professor of Public Administration and International Affairs, Syracuse University
  • Eric Campbell, PhD, Professor of Medicine, Harvard Medical School
  • Edward Cooney, JD, Former Executive Director, Congressional Hunger Center
  • Michael McGinnis, MD, Executive Officer, National Academy of Medicine
  • Sylvia Rowe, President, SR Strategy, LLC
  • Robert Steinbrook, MD, Professor Adjunct, Internal Medicine, Yale School of Medicine
  • Carol Tucker-Foreman, Distinguished Fellow, Consumer Federation of America Food Policy Institute
  • Catherine Woteki, PhD, Under Secretary for Research, Education and Economics, US Department of Agriculture
  • Patrick Stover, PhD, President, American Society for Nutrition (ex-officio member)
  • John Courtney, PhD, Executive Officer, American Society for Nutrition (ex-officio member)

The group is expected to complete its work within a year.  I eagerly await its report.

Feb 9 2016

Studies funded by a garlic supplement maker find specific health benefits for garlic. The score: 119/11.

I’m having trouble keeping up with industry-sponsored nutrition research so will use this week’s posts to catch up.  I’ll start with this one.

Nutrition journals often publish supplements on specific themes that are paid for by outside parties, food industry groups among them.  The February 2016 issue of the Journal of Nutrition contains a supplement with the papers from the 2014 International Garlic Symposium: “Role of Garlic in Cardiovascular Disease Prevention, Metabolic Syndrome, and Immunology.”

To distinguish supplement papers from peer-reviewed journal articles, citations give page numbers with the letter S.  The Journal of Nutrition’s exceptionally clear policy on supplement publications explains that organizers are expected to pay page charges of $75 per article and $300 per published page plus additional editorial costs as needed.  It views supplements as paid advertisements and requires full disclosure of funding sources.

Here’s the disclosure for the garlic supplement.

The symposium was sponsored by the University of California, Los Angeles School of Medicine and the University of Florida and co-sponsored by the American Botanical Council; the American Herbal Products Association; the ASN [American Society for Nutrition]; the Japanese Society for Food Factors; the Japan Society for Bioscience, Biotechnology, and Agrochemistry; the Japan Society of Nutrition and Food Science; and the Natural Products Association. The symposium was supported by Agencias Motta S.A.; Bionam; Eco-Nutraceuticos; Healthy U 2000 Ltd.; Magna; Mannavita Bvba; MaxiPharma; Medica Nord A.S.; Nature’s Farm Pte. Ltd.; Nature Valley W.L.L.; Organic Health Ltd.; Oy Valioravinto Ab; Purity Life Health Products L.P.; PT Nutriprima Jayasakti; Vitaco Health Ltd.; Vitae Natural Nutrition; Sanofi Consumer Health Care; Wakunaga Pharmaceutical Co., Ltd.; and Wakunaga of America Co., Ltd. The Chair of the conference and Scientific Program Coordinator for the supplement publication was Matthew J Budoff, Harbor-UCLA Medical Center, Torrance, CA. Scientific Program Coordinator disclosures: MJ Budoff has been awarded research grants from Wakunaga of America Co., Ltd., and received an honorarium for serving as Chair of the conference. Vice-Chair and Supplement Coordinator for the supplement publication was Susan S Percival, University of Florida, Gainesville, FL. Supplement Coordinator disclosures: SS Percival has been awarded research grants from Wakunaga of America Co., Ltd., and received an honorarium for serving as Vice-Chair of the conference. Publication costs for this supplement were defrayed in part by the payment of page charges. This publication must therefore be hereby marked “advertisement” in accordance with 18 USC section 1734 solely to indicate this fact. The opinions expressed in this publication are those of the authors and are not attributable to the sponsors or the publisher, Editor, or Editorial Board of The Journal of Nutrition [my emphasis].

Comment on scoring: Because they were presented at a symposium sponsored by food and supplement companies, all papers raise questions about industry sponsorship.  That is why the Journal requires every paper in the supplement to repeat this funding disclosure in its entirety.

But for this particular symposium, some of the papers report additional funding by Wakunaga of America, a company that, no surprise, manufactures garlic supplements.

All of the papers produced results useful to the sponsor.  Some of them, however, were independently funded and the authors report no links to the sponsor other than having given a talk at the meeting.  They did not disclose who paid for travel and hotels and without any way to check, I must assume that they paid their own expenses to the meeting in San Diego.  For the purposes of scoring, I’m not counting them as industry-funded, even though their presence at the symposium made it seem more scientifically credible.

Garlic Lowers Blood Pressure in Hypertensive Individuals, Regulates Serum Cholesterol, and Stimulates Immunity: An Updated Meta-analysis and Review.  Karin Ried.  J Nutr. 2016; 146:389S-396S doi:10.3945/jn.114.202192.

  • Conclusions: Our review suggests that garlic supplements have the potential to lower blood pressure in hypertensive individuals, to regulate slightly elevated cholesterol concentrations, and to stimulate the immune system. Garlic supplements are highly tolerated and may be considered as a complementary treatment option for hypertension, slightly elevated cholesterol, and stimulation of immunity.
  • Author disclosures: K Ried, no conflicts of interest. K Ried received travel sponsorship from Wakunaga of America Co. Ltd. to attend the 2014 International Garlic Symposium.
  • Score: industry-positive

Chemical Assignment of Structural Isomers of Sulfur-Containing Metabolites in Garlic by Liquid Chromatography−Fourier Transform Ion Cyclotron Resonance−Mass Spectrometry.  Ryo Nakabayashi, Yuji Sawada, Morihiro Aoyagi, Yutaka Yamada, Masami Yokota Hirai, Tetsuya Sakurai, Takahiro Kamoi, Daryl D Rowan, and Kazuki Saito.  J. Nutr. 2016; 146:397S-402S doi:10.3945/jn.114.202317.

  • Conclusion: The ability to discriminate between such geometric isomers will be extremely useful for the chemical assignment of unknown metabolites in MS-based metabolomics.
  • Supported, in part, by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology of Japan; Japan Advanced Plant Science Network; Japan Science Technology Agency (JST), Strategic International Collaborative Research Program (SICORP); and JST, Strategic International Research Cooperative Program (SICP).
  • Score: industry-neutral

Garlic-Derived Organic Polysulfides and Myocardial Protection.  Jessica M Bradley, Chelsea L Organ, and David J Lefer.  J. Nutr. 2016; 146:403S-409S doi:10.3945/jn.114.208066.

  • Conclusion: The beneficial health effects of garlic on cardiovascular health are dependent on multiple mechanisms. Furthermore, the mechanisms of action may be mediated by the active components in garlic.
  • Supported by grants from the National Heart, Lung, and Blood Institute (1R01 HL092141, 1R01 HL093579, 1U24 HL 094373, and 1P20 HL113452; to DJL) and by the Louisiana State University Health Foundation in New Orleans.
  • Score: Industry-neutral

Aged Garlic Extract Inhibits Human Platelet Aggregation by Altering Intracellular Signaling and Platelet Shape Change.  Khalid Rahman, Gordon M Lowe, and Sarah Smith.  J. Nutr. 2016; 146:410S-415S doi:10.3945/jn.114.202408

  • Conclusion: These results indicate that AGE [Aged Garlic Extract] inhibits platelet aggregation by increasing cyclic nucleotides and inhibiting fibrinogen binding and platelet shape change.
  • Funding: Supported by a grant from Wakunaga of America Co. Ltd.  K Rahman and GM Lowe were in receipt of a grant from Wakunaga of America Co., Ltd. S Smith, no conflicts of interest.
  • Score: industry-positive

Garlic and Heart Disease.  Ravi Varshney and Matthew J Budoff.  J. Nutr. 2016; 146:416S-421S doi:10.3945/jn.114.202333

  • Conclusion: We conclude that garlic supplementation has the potential for cardiovascular protection based on risk factor reduction (hypertension and total cholesterol) and surrogate markers (CRP, PWV, and CAC) of atherosclerosis.
  • Disclosures: The authors report no funding received for this study.  R Varshney, no conflicts of interest. MJ Budoff receives funding from Wakunaga of America Co., Ltd.
  • Score: industry-positive

The Role of Adiponectin in Cardiometabolic Diseases: Effects of Nutritional Interventions.  Patricio Lopez-Jaramillo.  J. Nutr. 2016; 146:422S-426S doi:10.3945/jn.114.202432

  • Conclusions: Recently, it was reported that the administration of aged garlic extract and a single food intervention with pistachios can increase adiponectin concentrations in individuals with metabolic syndrome. Moreover, the Mediterranean diet is associated with higher adiponectin concentrations. Additional studies are needed to evaluate the potential benefits of increasing adiponectin by nutritional interventions in the treatment and prevention of cardiometabolic diseases.
  • Funding: The author reports no funding received for this study.
  • Score:  Industry-neutral

Aged Garlic Extract Reduces Low Attenuation Plaque in Coronary Arteries of Patients with Metabolic Syndrome in a Prospective Randomized Double-Blind Study.  Suguru Matsumoto, Rine Nakanishi, Dong Li, Anas Alani, Panteha Rezaeian, Sach Prabhu, Jeby Abraham, Michael A Fahmy, Christopher Dailing, Ferdinand Flores, Sajad Hamal, Alexander Broersen, Pieter H Kitslaar, and Matthew J Budoff.  J. Nutr. 2016; 146:427S-432S doi:10.3945/jn.114.202424

  • Conclusions: This study indicates that the %LAP [Low Attenuation Plaque] change was significantly greater in the AGE group than in the placebo group. Further studies are needed to evaluate whether AGE has the ability to stabilize vulnerable plaque and decrease adverse cardiovascular events.
  • Disclosures: While the study was funded by Wakunaga of America Co., Ltd., the authors are solely responsible for the design, all study analyses, the drafting and editing of the paper and its final contents…S Matsumoto, R Nakanishi, D Li, A Alani, P Rezaeian, S Prabhu, J Abraham, MA Fahmy, C Dailing, F Flores, S Hamal, and A Broersen, no conflicts of interest. PH Kitslaar is employed by Medis Medical Imaging Systems and has a research appointment at the Leiden University Medical Center. MJ Budoff receives funding from Wakunaga of America Co., Ltd.
  • Score: industry-positive

Aged Garlic Extract Modifies Human Immunity.  Susan S Percival.  J.  Nutr. 2016; 146:433S-436S doi:10.3945/jn.115.210427

  • Conclusions: These results suggest that AGE supplementation may enhance immune cell function and may be partly responsible for the reduced severity of colds and flu reported. The results also suggest that the immune system functions well with AGE supplementation, perhaps with less accompanying inflammation.
  • Funding: Support for this research was provided by Wakunaga of America Co., Ltd.  Author disclosures: SS Percival received travel expenses to the conference where this work was presented.
  • Score: industry-positive

Bioavailability of Alfrutamide and Caffedymine and Their P-Selectin Suppression and Platelet-Leukocyte Aggregation Mechanisms in Mice.  Jae B Park.  J. Nutr. 2016; 146:437S-443S doi:10.3945/jn.114.202473

  • Conclusions: These data show the adequate bioavailability of alfrutamide and caffedymine and their different mechanisms of suppressing PSE and PLA: alfrutamide exerts its effects only via COX inhibition, whereas caffedymine works through both COX inhibition and cAMP amplification.
  • Funding: Supported by the USDA (project 8040-51000-057-00).
  • Score: Industry-neutral

Garlic Influences Gene Expression In Vivo and In Vitro.  Craig S Charron, Harry D Dawson, and Janet A Novotny.  J. Nutr. 2016; 146:444S-449S doi:10.3945/jn.114.202481

  • Conclusion: Measuring mRNA gene expression in whole blood may provide a unique window to understanding how garlic intake affects human health.
  • Support: CSC, HDD, and JAN were supported by the USDA.
  • Score: Industry-neutral.

Development of an Analytic Method for Sulfur Compounds in Aged Garlic Extract with the Use of a Postcolumn High Performance Liquid Chromatography Method with Sulfur-Specific Detection.  Toshiaki Matsutomo and Yukihiro Kodera.  J. Nutr. 2016; 146:450S-455S doi:10.3945/jn.114.208520

  • Conclusion: We developed a rapid postcolumn HPLC method for both qualitative and quantitative analyses of sulfur compounds, and this method helped elucidate a potential mechanism of cis-S1PC and SAMC action in AGE.
  • Acknowledgment: The authors thank Takami Oka of Wakunaga Pharmaceutical Co., Ltd. for his kind guidance for this study and critical review of the manuscript.
  • Score: Industry-positive

Pharmacokinetics of S-Allyl-L-cysteine in Rats Is Characterized by High Oral Absorption and Extensive Renal Reabsorption.  Hirotaka Amano, Daichi Kazamori, and Kenji Itoh.  J. Nutr. 2016; 146:456S-459S doi:10.3945/jn.114.201749

  • Conclusion: The pharmacokinetics of SAC in rats were characterized by high oral absorption, limited metabolism, and extensive renal reabsorption, all of which potentially contribute to its high and relatively long-lasting plasma concentrations.
  • Acknowledgment: We thank Takami Oka of Wakunaga Pharmaceutical Co. for his valuable advice, critical reading of the manuscript, and helpful suggestions.
  • Score: Industry-positive

Aged Garlic Extract Suppresses the Development of Atherosclerosis in Apolipoprotein E–Knockout Mice.  Naoaki Morihara, Atsuko Hino, Takako Yamaguchi, and Jun-ichiro Suzuki. J. Nutr. 2016; 146:460S-463S doi:10.3945/jn.114.206953

  • Conclusion: These data suggest that the antiatherosclerotic activity of AGE is at least partly due to the suppression of inflammation and lipid deposition in the vessels during the early stage of atherosclerotic development in ApoE-KO mice.
  • Acknowledgment: We thank Takami Oka of Wakunaga Pharmaceutical Co., Ltd., for his helpful advice, encouragement, and critical reading of this manuscript; Yukihiro Kodera of Wakunaga Pharmaceutical Co., Ltd., for the preparation of AGE; and Tadamitsu Tsuneyoshi of Wakunaga Pharmaceutical Co., Ltd., for his technical advice.
  • Score: Industry-positive

This makes 8 industry-positives from this journal supplement.

But let me add one more on this topic, sent by a reader:

The effect of aged garlic extract on blood pressure and other cardiovascular risk factors in uncontrolled hypertensives: the AGE at Heart trial.  Karin Ried Nikolaj Travica, Avni Sali.  Integrated Blood Pressure Control, 27 January 2016.

  • Conclusion: Our trial suggests that aged garlic extract is effective in reducing peripheral and central blood pressure in a large proportion of patients with uncontrolled hypertension, and has the potential to improve arterial stiffness, inflammation, and other cardiovascular markers in patients with elevated levels. Aged garlic extract was highly tolerable with a high safety profile as a stand-alone or adjunctive antihypertensive treatment.
  • Funding: This trial was supported by a grant from Wakunaga of America Co Ltd, who sup­plied trial capsules and provided funding for costs of tests and research assistance. Wakunaga of America was not involved in study design, data collection, analysis, or prepa­ration of the manuscript…The authors report no conflicts of interest in this work.
  • Score: industry-positive, of course.

This brings the score since last March to 119 industry-positives/11 industry-negatives.