by Marion Nestle

Currently browsing posts about: 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.

Feb 4 2016

Five more industry-sponsored marketing studies. The score 110:11.

Here are some recent additions to my ever-growing collection of industry-funded food and nutrition studies or commentaries with results favorable to the sponsor’s interests.  These bring the total since last March to 110 with favorable results versus 11 with those that must have disappointed the sponsor.

Reduced dietary intake of simple sugars alters perceived sweet taste intensity but not perceived pleasantness. Paul M Wise, Laura Nattress, Linda J Flammer, and Gary K Beauchamp. Am J Clin Nutr 2016; 103:50-60.  doi:10.3945/ajcn.115.112300

  • Conclusions: This experiment provides empirical evidence that changes in consumption of simple sugars influence perceived sweet taste intensity. More work is needed to determine whether sugar intake ultimately shifts preferences for sweet foods and beverages.
  • Supported by PepsiCo Inc. and Monell Chemical Senses Center institutional funds.
  • Comment: This study shows that if you eat less sugar, even low-sugar foods taste sweet.  Soft drink companies are under pressure to reduce sugar.  If these results are correct, soda companies ought to be able to get away with reducing their sugar content—at least if customers get used to consuming less sugar and accept drinks that are not so intensely sweet. 

Consuming yellow pea fiber reduces voluntary energy intake and body fat in overweight/obese adults in a 12-week randomized controlled trial.  Jennifer E. Lambertemail, Jill A. Parnellemail, Jasmine M. Tunnicliffe, Jay Han, Troy Sturzenegger, Raylene A. Reimer. Clinical Nutrition, Article in press published online January 11, 2016.  DOI: http://dx.doi.org/10.1016/j.clnu.2015.12.016

  • Conclusions:  In the absence of other lifestyle changes, incorporating 15 g/day yellow pea fiber may yield small but significant metabolic benefits and aid in obesity management.
  • Funding: The study was funded by Alberta Innovates Bio Solutions, Alberta Innovates Health Solutions and Alberta Pulse Growers Commission.

Effect of flavored milk vs plain milk on total milk intake and nutrient provision in children.  Flavia Fayet-Moore. Nutrition Reviews Jan;74(1):1-17. doi: Here’10.1093/nutrit/nuv031. Epub 2015 Nov 3.

  • Conclusions: There is no association between flavored milk intake and weight status among normal-weight children, and some contradictory effects of flavored milk intake have been observed in subgroups of overweight children. Flavored milk is a palatable beverage choice that helps children to meet calcium targets.
  • Financial disclosures. The author received a research grant from Nestlé Australia Ltd to conduct.

Does milk consumption contribute to cardiometabolic health and overall diet quality?  Lamarche B, Givens I, Soedamah-Muthu S, Krauss RM, Jakobsen MU, Bischoff-Ferrari HA, Pan A, Després J-P, Canadian Journal of Cardiology (2016), doi: 10.1016/j.cjca.2015.12.033.

  • Conclusion: The evidence to date suggests a neutral effect of milk intake per se on several health-related outcomes. The possibility that milk intake is simply a marker of higher nutritional quality diets cannot be ruled out and needs to be further examined in future studies.
  • Authors’ disclosures (in supplementary online material): BL is Chair of Nutrition at Laval University, which Board of Directors include a representative from Provigo-Loblaws. BL has received funding from Agri-food and Agriculture Canada, the Dairy Farmers of Canada (DFC), Dairy Australia and Dairy Research Institute to study dairy and health. He serves as the Chair of the independent, peer-review Expert Scientific Advisory Council of DFC. BL has also received honoraria from DFC as invited speaker in various conferences. MUJ has received honoraria from the Global Dairy Platform to review the observational epidemiological evidence of associations between intake of trans fatty acids and risk of CHD and from the European Milk Forum as an invited speaker at symposia. IG is Chair of Food Chain Nutrition at the University of Reading. He has received funding from the UK Dairy Council, AHDB Dairy, the Barham Benevolent Trust and the UK Medical Research Council for studies on dairy and health. He has also received honoraria from the Dairy Council as an invited speaker at various conferences. He serves on various committees including being the Deputy Chair of the UK Food Standards Agency committee concerned with food chain related aspects of food safety. SSSM previously received unrestricted research grants from Global Dairy Platform, Dairy Research Institute and Dairy Australia for projects related to dairy effects on lipoproteins and mortality. RMK has received grant support from Dairy Management, Inc. Other authors have no disclosures related to the content of this paper.

Including “Added Sugars” on the Nutrition Facts Panel: How Consumers Perceive the Proposed Change.  Idamarie Laquatra, Kris Sollid, Marianne Smith Edge, Jason Pelzel, John Turner.  Published Online: June 09, 2015. DOI: http://dx.doi.org/10.1016/j.jand.2015.04.017|

  • Conclusion: In this analysis, rather than improving consumer understanding about the amount of total sugars in a product, NFPs with “Added Sugars” declarations were misleading and the resulting misperception influenced purchase intent.
  • Statement of potential conflict of interest: No potential conflict of interest was reported by the authors.
  • Funding support: This research was commissioned and funded by the International Food Information Council Foundation and conducted by Turner Research Network of Atlanta, GA. More details about the International Food Information Council Foundation can be found at http://www.foodinsight.org/pages/faqs.
  • Comment: IFIC is funded by food and beverage companies (see SourceWatch).  The FDA is currently considering putting a line for Added Sugars on food labels.  Food companies, understandably, oppose this idea.
Jan 27 2016

Two industry-funded studies with results that must have disappointed sponsors. The score: 105/11

Sharp-eyed readers have sent in two studies sponsored by food companies with results that will be difficult to use for marketing.  This brings the score since mid-March to 105 sponsored studies useful in marketing to 11 that are not.

Effects of Pomegranate Extract Supplementation on Cardiovascular Risk Factors and Physical Function in Hemodialysis Patients. Wu Pei-Tzu, Fitschen Peter J., Kistler Brandon M., Jeong Jin Hee, Chung Hae Ryong, Aviram Michael, Phillips Shane A., Fernhall Bo, and Wilund Kenneth R.. Journal of Medicinal Food. September 2015, 18(9): 941-949. doi:10.1089/jmf.2014.0103.

  • Conclusions: Systolic blood pressure and diastolic blood pressure were reduced by 24±13.7 and 10±5.3 mmHg, respectively, in POM (P<.05). However, the BP differences in POM were no longer significant after controlling for baseline BP…However, pomegranate supplementation had no effect on other markers of cardiovascular disease risk, inflammation and oxidative stress, or measures of physical function and muscle strength. While pomegranate extract supplementation may reduce BP and increase the antioxidant activity in HD patients, it does not improve other markers of cardiovascular risk, physical function, or muscle strength.
  • Funding: This work was supported by the POM Wonderful, LLC.

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 cohort.  Jaike Praagman, Joline WJ Beulens, Marjan Alssema, Peter L Zock, Anne J Wanders, Ivonne Sluijs, and Yvonne T van der Schouw.  Am J Clin Nutr. First published ahead of print January 20, 2016 as doi: 10.3945/ajcn.115.122671

  • Conclusions: In this Dutch population, higher SFA intake was not associated with higher IHD risks. The lower IHD risk observed did not depend on the substituting macronutrient…Residual confounding by cholesterol-lowering therapy and trans fat or limited variation in SFA and PUFA intake may explain our findings.
  • Authors’ disclosures: JP is financially supported by a restricted research grant from Unilever Research and Development, Vlaardingen, Netherlands. MA, AJW, and PLZ are employees of Unilever Research and Development. None of the other authors reported a conflict of interest related to this study.
  • Comment: Unilever sells low-saturated fat/high-polyunsaturated fat margarines (e.g., Flora, Becel) for reducing coronary risk.  If higher saturated fat intake does not increase heart disease risk (perhaps because the study subjects were on statins), these products are unnecessary.
Jan 21 2016

This week’s five industry-funded studies. The score: 105/9.

I’ve collected five more studies funded directly or indirectly by food companies or trade associations, with results useful for marketing purposes.  This brings the total to 105 that I’ve noticed since last March versus only 9 with results that must have disappointed the sponsors.

Canned Vegetable and Fruit Consumption Is Associated with Changes in Nutrient Intake and Higher Diet Quality in Children and Adults: National Health and Nutrition Examination Survey 2001-2010Marjorie R. Freedman, PhD; Victor L. Fulgoni III, PhD.  J Acad Nutr Diet. 2015  http://dx.doi.org/10.1016/j.jand.2015.10.013.

  • Conclusions: Results suggest CVþCF consumption was associated with higher intake of select nutrients, a higher-quality diet, and comparable adiposity measures and blood pressure.
  • Funding for this project was received from the Canned Food Alliance.  As senior vice president at Nutrition Impact, LLC, V. L. Fulgoni III provides food and nutrition consulting and database analyses for various members of the food and beverage industry.  No potential conflict of interest was reported by M. R. Freedman.

Regular Fat and Reduced Fat Dairy Products Show Similar Associations with Markers of Adolescent Cardiometabolic Health.   O’Sullivan, T.A.; Bremner, A.P.; Mori, T.A., Beilin, L.J., Wilson, C., Hafekost, K., Ambrosini, G.L., Huang, R.C., Oddy, W.H..Nutrients 2016, 8, 22.

  • Conclusion: 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.
  • Conflicts of Interest: Therese A. O’Sullivan received a grant from The Dairy Health and Nutrition Consortium Australia…which provided funding for the analysis and write up of this study. No other authors declare a conflict of interest.

Suboptimal Plasma Long Chain n-3 Concentrations are Common among Adults in the United States, NHANES 2003–2004. Rachel A. Murphy, Elaine A. Yu, Eric D. Ciappio, Saurabh Mehta and Michael I. McBurney   Nutrients 2015, 7, 10282–10289; doi:10.3390/nu7125534.

  • Conclusion: Suboptimal LCn-3 [omega-3] concentrations are common among U.S. adults. These findings highlight the need to increase LCn-3 intake among Americans.
  • Conflicts of Interest: M.I.M., E.D.C. and R.A.M. are employees of D.S.M. Nutritional Products, L.L.C., manufacturers and suppliers of omega-3 nutritional lipids. E.Y. and S.M. have no conflicts of interest to disclose.

Red Raspberries and Their Bioactive Polyphenols: Cardiometabolic and Neuronal Health Links.  Britt M Burton-Freeman, Amandeep K Sandhu, and  Indika Edirisinghe.  Adv Nutr January 2016 Adv Nutr vol. 7: 44-65, 2016. doi: 10.3945/​an.115.009639

  • Conclusion: The body of research is growing and supports a potential role for red raspberries in reducing the risk of metabolically based chronic diseases.
  • Funding: Supported in part by various donors and the National Processed Raspberry Council.

Dietary flavonoid intake and incidence of erectile dysfunction. Aedín Cassidy, Mary Franz, and Eric B Rimm.  American Journal of Clinical Nutrition. First published ahead of print January 13, 2016 as doi: 10.3945/ajcn.115.122010.

  • Conclusions: These data suggest that a higher habitual intake of specific flavonoid-rich foods is associated with reduced ED incidence. Intervention trials are needed to further examine the impact of increasing intakes of commonly consumed flavonoid-rich foods on men’s health.
  • Authors’ disclosure: AC and EBR received funding from the US Blueberry Highbush Council for a separate project unrelated to this publication.
  • Comment: The University of East Anglia, where the lead author works, sent out a press release “Blueberries associated with reduced risk of erectile dysfunction.”
Jan 20 2016

Congratulations to the Academy of Nutrition and Dietetics’ for its new sponsorship policy

Several members of the Academy of Nutrition and Dietetics (AND–formerly the American Dietetic Association) sent me a letter from the Academy’s president, Evelyn Crayton, announcing its new policy on sponsorship.

AND’s previous policy, which encouraged sponsorship by food companies selling fast food, salty snacks, and sugary drinks, has been the subject of a critical investigative report and induced members of the Academy to create Dietitians for Professional Integrity to get the policy changed.

This advocacy worked.  It induced AND’s leadership to appoint a Sponsorship Advisory Task Force (SATF) to recommend a less conflicted policy to AND’s Board of Directors.

The SATF delivered its report to the Board on January 13.  As Evelyn Crayton explains,

The Board voted to implement a pilot program encompassing many of the SATF’s recommendations. The one-year pilot program includes appointing a Sponsorship Committee to review national-level sponsor opportunities and to develop assessment tools that will support the sponsorship process.

The Board of Directors approved the following newly revised sponsorship guidelines, which take effect immediately for all Academy organizational units. Dietetic Practice Groups and Member Interest Groups will be required to adhere to these guidelines and Affiliates are encouraged to adopt them.

Sponsorship approval requires that:

  • The sponsor’s vision and mission align with the Academy’s Vision, Mission and Strategic Goals.
  • The sponsor’s product portfolio is broadly aligned with the Academy’s Vision: Optimizing health through food and nutrition.
  • The sponsor relationship and sponsor product portfolio are broadly aligned with official Academy positions.
  • All aspects of the sponsorship (such as research, consumer messaging or professional education for members) align with the Academy’s Scientific Integrity Principles.
  • The Academy does not endorse any company, brand or company products, nor does the Academy’s name or logo appear on any product. Such endorsement is neither actual nor implied.
  • The Academy maintains final editorial control and approval of all content in materials bearing the Academy name or logo.
  • There is clear separation of Academy messages and content from brand information or promotion.
  • Relevant facts and important information are included.
  • The Board is confident that these revised guidelines and the new Sponsorship Committee pilot program will enable the Academy to better serve the organization and our members.

This looks impressive and deserves congratulations.  The policy calls for transparency, separation, and alignment—all laudable goals.

I have only two concerns:

  • What did the SATF report actually say?  How about making it available?  [If anyone has a copy and can send, please do.]
  • What is the definition of “alignment with the Academy’s goals and principles?”

As always, the devil is in the details.  As Andy Bellatti explains,

Some of these guidelines (i.e.: “the sponsor’s mission and vision align with AND’s”) already exist in the current policy — the same policy that considered PepsiCo (and former sponsors Coca-Cola, Kellogg’s, and General Mills) an appropriate sponsor.

The Academy’s Board can start the process by making the SATF report public (at least to members) and then explaining its process for setting the policy.*

It also needs to explain how “alignment” will be defined.  What are the actual criteria for deciding whether AND will accept food-industry sponsorship.

But this is a great first step and deserves much praise.

*Update: the Academy released the report.

Jan 14 2016

Five more industry-sponsored studies. The score 100:9

If you have been following this saga, you will know that since mid-March 2015 I’ve been collecting examples of published research supported wholly or in part by food companies.  As of today, the collection includes 95 studies with results favorable to the sponsor’s marketing interests as opposed to just 9 with unfavorable results.

Here are the most recent five.  These bring up general and specific questions that I’m pondering these days and I’ve indicated them in red.

The Effects of Water and Non-Nutritive Sweetened Beverages on Weight Loss and Weight Maintenance: A Randomized Clinical Trial.  John C. Peters, Jimikaye Beck, Michelle Cardel, Holly R. Wyatt, Gary D. Foster, Zhaoxing Pan, Alexis C. Wojtanowski, Stephanie S. Vander Veur, Sharon J. Herring, Carrie Brill, and James O. Hill. Obesity (2015) 00, 00–00. doi:10.1002/oby.21327.

  • Conclusions: Water and NNS [non-nutritive sweetened] beverages were not equivalent for weight loss and maintenance during a 1-year behavioral treatment program. NNS beverages were superior for weight loss and weight maintenance in a population consisting of regular users of NNS beverages who either maintained or discontinued consumption of these beverages and consumed water during a structured weight loss program. These results suggest that NNS beverages can be an effective tool for weight loss and maintenance within the context of a weight management program.
  • Funding agencies: The study was fully funded by The American Beverage Association. The American Beverage Association was not involved in the design, conduct, interpretation, or manuscript preparation of this study. Furthermore, a third-party organization (Biofortis-Provident) was hired at the PIs’ request. Biofortis-Provident audited data at both clinical sites to check for the accuracy and integrity of the data…Disclosure: J.C.P. and J.O.H. received consulting fees from The Coca-Cola Company outside of the submitted work.
  • Questions: Does recruiting a third party to audit data increase confidence in the credibility of this study?  Isn’t it more relevant to ask about how the research question is framed? 

Nutrition and Health Disparities: The Role of Dairy in Improving Minority Health Outcomes.  Constance Brown-Riggs.  Int. J. Environ. Res. Public Health 2016, 13(1), 28; doi:10.3390/ijerph13010028.

  • Conclusion: Because of the presence of lactase-producing cultures, yogurt is often a more easily digestible alternative to milk, and thus more palatable to people who experience symptoms of lactose intolerance. This was a key factor cited in the final rule to include yogurt in the Special Supplemental Nutrition Program for Women, Infants, and Children.
  • Funding: This work was supported by The Dannon Company Inc. (White Plains, NY). The Dannon Company Inc. provided information for this article but did not have final approval for its content.
  • Conflicts of Interest: Nutrition advisor for Dannon’s One Yogurt Everyday Initiative, providing consultation services on the health issues affecting African Americans.

Protein Supplementation at Breakfast and Lunch for 24 Weeks beyond Habitual Intakes Increases Whole-Body Lean Tissue Mass in Healthy Older Adults.  Catherine Norton, Clodagh Toomey, William G McCormack, Peter Francis, Jean Saunders, Emmet Kerin, and Philip Jakeman.  Nutr. 2016; 146:65-69 doi:10.3945/jn.115.219022.

  • Conclusions: Protein supplementation at breakfast and lunch for 24 wk in healthy older adults resulted in a positive (+0.6 kg) difference in LTM compared with an isoenergetic, nonnitrogenous maltodextrin control. These observations suggest that an optimized and balanced distribution of meal protein intakes could be beneficial in the preservation of lean tissue mass in the elderly.
  • Funding: Supported by Food for Health Ireland and Enterprise Ireland grant CC20080001.  Author disclosures: C Norton, C Toomey, P Francis, J Saunders, E Kerin, and P Jakeman, no conflicts of interest. WG McCormack was an employee of Carbery Ingredients on secondment to Food for Health Ireland during the in vivo data collection and analysis.
  • Comment: The Carbery Group advertises itself as “a global leader in food ingredients, flavours and cheese.”
  • Question: Why would Carbery put one of its employees to work on this study?

Dietary vitamin D dose-response in healthy children 2 to 8 y of age: a 12-wk randomized controlled trial using fortified foods.  Neil R Brett, Paula Lavery, Sherry Agellon, Catherine A Vanstone, Jonathon L Maguire, Frank Rauch, and Hope A Weiler.  Am J Clin Nutr 2016; 103:144-152 doi:10.3945/ajcn.115.115956.

  • Conclusion: Increasing the vitamin D intakes of young children through fortification of alternative dairy products results in significantly higher serum concentrations of 25(OH)D and a significantly greater proportion of children with serum 25(OH)D $50 nmol/L during periods of minimal ultraviolet B radiation exposure.
  • Supported by funding from Dairy Farmers of Canada, the Canadian Foundation for Innovation and Canada Research Chairs, and in-kind support from Agropur and Ultima Foods for the study products.
  • Question: Does providing study products introduce conflicts of interest?

Comparison of the DASH (Dietary Approaches to Stop Hypertension) diet and a higher-fat DASH diet on blood pressure and lipids and lipoproteins: a randomized controlled trial.  Sally Chiu, Nathalie Bergeron, Paul T Williams, George A Bray, Barbara Sutherland, and Ronald M Krauss.

  • Conclusions: The HF-DASH diet lowered blood pressure to the same extent as the DASH diet but also reduced plasma triglyceride and VLDL concentrations without significantly increasing LDL cholesterol
  • Supported by Dairy Management Inc. and by the National Center for Research Resources and the National Center for Advancing Translational Sciences, NIH, through University of California, San Francisco Clinical & Translational Science Institute grant UL1 RR024131.  RMK has previously received and is currently receiving research funding from Dairy Management Inc. for this and other projects. None of the other authors reported a conflict of interest. This was an investigator-initiated study, and its financial supporters had no role in the study design, implementation, data analysis, or data interpretation.
  • Question: Does this mean that the investigators decided what they wanted to study and then asked Dairy Management Inc for funding, knowing that Dairy Management would have congruent interests?  Does something like this increase confidence in the results?

I don’t have clear, unambiguous answers to such questions and am collecting opinions in preparation for my next book project.  If you have thoughts about these matters, do share.

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