Search results: american journal of clinical nutrition

If you are a marketer of fruit juice, you have a problem.  Fruit juice has a lot of sugar and retains little of the fiber of whole fruit.  Dietary recommendations increasingly suggest limits on the amounts consumed, especially for children.

But according to the trade group, the Juice Products Association, “The 2015 Dietary Guidelines for Americans and the American Academy of Pediatrics (AAP) concur that 4 to 6 ounces of 100% fruit juice per day is appropriate for young children. For children age 7 and older, the AAP recommends a daily serving of 8 to 12 ounces per day.”

No it does not!  The American Academy of Pediatrics suggests a limit to that amount.  Big difference.

Juice should not be introduced into the diet of infants before 12 months of age unless clinically indicated. The intake of juice should be limited to, at most, 4 ounces/day in toddlers 1 through 3 years of age, and 4 to 6  ounces/day for children 4 through 6 years of age. For children 7 to 18 years of age, juice intake should be limited to 8 ounces or 1 cup of the recommended 2 to 2.5 cups of fruit servings per day.

What about adults?  Adults do not need more sugars or the calories they provide.   They too would be better off eating fruit.

Juice trade associations to the rescue.

The study:  100% Fruit juice intake and cardiovascular risk: a systematic review and meta-analysis of prospective and randomised controlled studies. Lanfranco D’Elia, et al.  European Journal of Nutrition (2020)

Methods: This is a meta-analysis of prospective studies and randomized controlled trials (RCTs) examining the relationship between consumption of 100% fruit juice (FJ) and the risk of cardiovascular disease (CV).

Conclusions: “The results of these analyses indicate that 100%FJ consumption is not associated with higher CV risk. A non-linear inverse dose–response relationship occurs between 100%FJ consumption and CV disease, in particular for risk of stroke, probably mediated by the decrease in blood pressure.”

Funding: “Open access funding provided by Università degli Studi di Napoli Federico II within the CRUI-CARE Agreement. This project was funded by the European Fruit Juice Association (AIJN) via an unrestricted grant. AIJN was not involved in the design, conduction, analysis and interpretation of the results.”

Comment: Why would anyone think that fruit juice, of all things, would be associated with heart disease risk?  You would have to be drinking a lot of it —at the exclusion of healthier foods—for it to make  a significant difference.  The only point of this study is to try to convince adults to drink more juice.  When I was a kid, fruit juice was expensive and we drank it in 4-ounce glasses.  If you drink fruit juice at all, that’s still a good idea.

The press release from the Annals of Internal Medicine arrived last week under embargo, sent to me by several reporters: “New guidelines: No need to reduce red or processed meat consumption for good health.”

The press announcement was accompanied by 5 review papers, a sixth with this recommendation, and an editorial.  These are posted on the website of their publisher, the American College of Physicians, implying this organization’s endorsement of this guideline.

Collectively, these papers challenge dietary advice to eat less processed meat and red meat on the grounds of inadequate science.

These papers argue:

• Eliminating processed and red meat from the diet may reduce disease risks but the effects are small and evidence for them is of low quality and low certainty.
• Omnivores are unwilling to eat less meat.
• If you continue to think eating meat is bad for you in the face of this evidence, you are a victim of the “the less you know, the more you hold to your beliefs” syndrome.
• You can ignore dietary guidelines (regardless of source) and continuing eating meat as you always have.

This is a good example of what I call nutritional nihilism, an approach that insists that because observational studies are based on self-reported information and necessarily flawed, their conclusions are unscientific and should be discounted.  Therefore, because we can’t do more rigorous studies, we should not advise the public about diets best for health or the environment.

I have several concerns about all this:

• Yes, the effects are small but that is true of nutrition studies in general.  The small effects show benefits from eating less meat.  The authors could easily have interpreted their work as suggesting that eating less meat might be useful.  This is an example of interpretation bias.
• The authors took a strictly science-based approach to a problem strongly affected by social, economic, and political factors and values.
• The studies look at previous studies that compared people who eat meat to those who eat less. The authors excluded studies of vegetarians compared to meat-eaters.
• They look at meat outside its context of calories.
• The authors did not look at the totality of the evidence; they excluded laboratory and animal studies that can be more closely controlled.
• They excluded studies of environmental impact, which has a significant bearing on human dietary practices (meat production adds more greenhouse gases than vegetable production).
• The conclusions fall into the category of “everything you thought you knew about nutrition is wrong.”  This rarely happens.  Science usually works incrementally, not in one enormous reversal like this.

Do the authors really believe that all those other committees and commissions urging less meat were wrong and continue to be wrong?   Their strictly science-based approach seems unrealistic.

The papers come across to me as a concerted attack on dietary guidelines (national and international), on nutrition science in general, and on nutritional epidemiology in particular.

The meat industry and its supporters will love them.

Attacks on the quality of nutrition research have been coming from many sources lately: the food industry, of course, but also statisticians (John Ioannidis at Stanford is making a career of this), and some scientists (usually with ties to food companies).  The criticisms themselves are not new.

What is new is the vehemence and level of effort to discredit observational studies, particularly those based on self-reports of dietary intake.  Yes, nutritional epidemiology has flaws, but the methods have been useful in many instances, as argued convincingly by two of its leading practitioners.

In looking at nutrition research, I think it is essential to evaluate the totality of information available: laboratory, animal, human epidemiology and clinical studies—and to do this in the context of what people actually eat and the number of calories they consume, as well as adding in a hefty dose of common sense.

Common sense is what’s missing in these studies.  Do the authors really believe that:

• Meat eaters are healthier than vegetarians?
• Eating more meat is better for health?
• Meat eaters are less obese and have less heart disease and cancer than those who eat less?

If not, the conclusions make no sense.

Most of the authors report no financial ties to the food industry.  I would love to know the back story about why they chose to do these studies and to interpret them in this way.

Reactions (I will be adding to this list as they come in)

• The Harvard School of Public Health Nutrition Department issued a statement
• The True Health Initiative (THI) issued a press release outlining its concerns (the link is here)
• THI council members sent a letter to the journal editor stating objections (the link)
• THI collected quotes from members of its council and others (including mine)
• THI also produced graphics.  Here is one example.

• David Katz weighs in
• New York Times: 5 things you should know
• New York Times coverage: “Eat less meat, scientists said.  Now some believe that was bad advice.”
• From Dean Ornish
• Consumer Reports (I’m quoted)
• From the World Cancer Research Fund
• Vox’s crystal clear explanation
• NPR’s The Salt’s excellent analysis
• Aaron Carroll’s follow-up to his editorial

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

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

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

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

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

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

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

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

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

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

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

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

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

Let me start with a reminder that since mid-March I’ve been collecting examples of studies funded by food companies or trade associations that come up with results favorable to the sponsor’s interests.  I post them five at a time.  I am having a hard time finding industry-funded studies that do not favor the sponsor’s interests.  If you run across any, please send.  Here’s the latest collection.

Mediterranean Diet and Invasive Breast Cancer Risk Among Women at High Cardiovascular Risk in the PREDIMED Trial: A Randomized Clinical Trial.  Estefanía Toledo, MD, MPH, PhD; Jordi Salas-Salvadó, MD, PhD; Carolina Donat-Vargas, PharmD; et al.  JAMA Intern Med. Published online September 14, 2015. doi:10.1001/jamainternmed.2015.4838

• Conclusions and Relevance  This is the first randomized trial finding an effect of a long-term dietary intervention on breast cancer incidence. Our results suggest a beneficial effect of a Mediterranean diet supplemented with extra-virgin olive oil in the primary prevention of breast cancer.
• Conflict of Interest Disclosures: Dr Salas-Salvadó received grants from Instituto de Salud Carlos III and the International Nut and Dried Fruit Foundation during the conduct of the study and has received consultancy fees from Danone Research and Eroski outside the present work; he is also a nonpaid member of the Scientific Committee of the International Nut and Dried Fruit Foundation. Dr Estruch, outside the present work, has received grants from the California Walnut Commission, nonfinancial support from Patrimonio Comunal Olivarero (Spain), La Morella Nuts (Spain), and Borges SA (Spain) and grants from Novartis Farmaceutica SA, Cerveceros De España, Sanofi, FIVIN-Spain, Instituto Cervantes Albuquerque, the Harvard School of Public Health, the Culinary Institute of America, the International Family Doctors Association, and Instituto Cervantes (Milan, Italy). Dr Ros, during the conduct of the study, received grants from Instituto de Salud Carlos III and nonfinancial support from the California Walnut Commission, Patrimonio Comunal Olivarero, La Morella Nuts, and Borges SA. Dr Ros, outside the present work, has received grants from the California Walnut Commission and nonfinancial support from Nuts for Life, La Asturiana SA, the International Nut and Dried Fruit Council, and the California Walnut Commission and personal fees and other compensation from Nuts for Life and La Asturiana SA. Dr Hu, outside the present work, has received grants from the California Walnut Commission and Metagenics. Dr Fitó, outside the present work, has received personal fees from Menarini and AstraZeneca. No other disclosures are reported.
• Funding/Support: Although most funding support came from government agencies, “The supplemental foods used in the study were generously donated by Patrimonio Comunal Olivarero and Hojiblanca, Spain (EVOO); the California Walnut Commission, Sacramento, California (walnuts); and Borges SA (almonds) and La Morella Nuts (hazelnuts), both from Reus, Spain.”

Evaluation of 4-methylimidazole, in the Ames/Salmonella test using induced rodent liver and lung S9 Carol Beevers^1,* and Richard H. Adamson.  Environ. Mol. Mutagen., Article first published online: 10 SEP 2015.  DOI: 10.1002/em.21968.   

• Conclusions: No induction of mutation (as measured by an increase in revertant colonies) was observed and it was concluded that 4-MeI was not mutagenic in S. typhimurium using either rodent liver or lung S9 for exogenous metabolism.
• Conflicts of Interest: The work described in this publication…was funded entirely by the American Beverage Association. ABA had no direct involvement in the study design, collection, analysis or interpretation of the data. ABA were not involved in the writing of this manuscript or the decision to submit the manuscript for publication. Richard H Adamson has received fees for serving as a consultant for the American Beverage Association. He was an observer for the International Technical Caramel Association for IARC Monograph- volume 101 and acted as Study Monitor for the work described in this manuscript. Carol Beevers is an employee of Covance Laboratories Ltd and acted as GLP Study Director for the work described in this manuscript.
• Comment: 4-MEI is a chemical produced during the Maillard (browning) reaction and found as a component of caramel coloring in diet sodas.  It is listed as a probable carcinogen under California’s proposition 65 rules, and CSPI has petitioned the FDA to require companies to remove it.

Reduced Symptoms of Inattention after Dietary Omega-3 Fatty Acid Supplementation in Boys with and without Attention Deficit/Hyperactivity Disorder.  Dienke J Bos, Bob Oranje, E Sanne Veerhoek, Rosanne M Van Diepen, Juliette MH Weusten, Hans Demmelmair, Berthold Koletzko, Monique GM de Sain-van der Velden, Ans Eilander, Marco Hoeksma, and Sarah Durston.  Neuropsychopharmacology. 2015 Sep; 40(10): 2298–2306.  Published online 2015 Apr 22.  doi:  10.1038/npp.2015.73.

• Conclusion: this study offers support that omega-3 supplementation may be an effective augmentation for pharmacological treatments of ADHD [Attention deficit/hyperactivity disorder].
• Funding: This study was financially supported by Unilever Research & Development, Vlaardingen, The Netherlands. Unilever Research & Development was involved in the conception and design of the study. They provided financial support for research staff to run the study and provided the intervention product.  Marco Hoeksma and Ans Eilander are employees of Unilever.

Milk Modulates Campylobacter Invasion into Caco-2 Intestinal Epithelial Cells. Rogier Louwen, R. J. Joost van Neerven.  European Journal of Microbiology and Immunology 5 (2015) 3, pp. 1–7 2015.  doi:10.1556/1886.2015.00019.

• Conclusions: We found that all milk products modulated the invasion of Campylobacter species into the Caco-2 cells in a dose-dependent manner…This in vitro study shows for the first time that pasteurized and formula milk affect the invasion of Campylobacter… Industrially made milk-based formulas…specifically reduced the invasion of the C. coli and C. fetus strain into the Caco-2 cells.
• Funding: “Part of this study was supported by FrieslandCampina by paying material costs, but FrieslandCampina was not involved in study design or data analysis.”
• Comment: FrieslandCampina makes dairy-based beverages, infant nutrition, cheese and desserts, and sells them in Europe, Asia, and Africa.  The study results suggest that even pasteurized milk contains substances that reduce pathogenic bacteria, at least in cell cultures.

Effect of the probiotic strain Bifidobacterium animalis subsp. lactis, BB-12^®, on defecation frequency in healthy subjects with low defecation frequency and abdominal discomfort: a randomised, double-blind, placebo-controlled, parallel-group trial.   Dorte Eskesen, Lillian Jespersen, Birgit Michelsen, Peter J. Whorwell, Stefan Müller-Lissner and Cathrine M. Morberg. British Journal of Nutrition. DOI: http://dx.doi.org/10.1017/S0007114515003347 , 9 pages. Published online: 18 September 2015.

• Conclusions: Overall, 4 weeks’ supplementation with the probiotic strain BB-12® resulted in a clinically relevant benefit on defecation frequency. The results suggest that consumption of BB-12® improves the GI health of individuals whose symptoms are not sufficiently severe to consult a doctor.
• Funding: Design, conduct, analysis and reporting of the study, as well as writing of this manuscript, were funded in full by Chr. Hansen…S. M.-L. and P. J. W. perform consultancy work for Chr. Hansen A/S. L. J., D. E., C. M. M. and B. M. are employees of Chr. Hansen A/S.
• Comment: Chr. Hansen develops and produces cultures, enzymes and probiotics for the dairy industry in particular as well as products for dietary supplements, pharmaceuticals and infant formula.

The Inadmissibility of What We Eat in America and NHANES Dietary Data in Nutrition and Obesity Research and the Scientific Formulation of National Dietary Guidelines. Archer E, Pavela G, Lavie CJ. Mayo Clin Proc. 2015 Jul;90(7):911-26. doi: 10.1016/j.mayocp.2015.04.009. Epub 2015 Jun 9.

• Conclusion: we conclude that M-BM [memory-based dietary assessment methods] data cannot be used to inform national dietary guidelines and that the continued funding of M-BMs constitutes an unscientific and major misuse of research resources.
• Funding: National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
• Potential Competing Interests: Dr Archer has received honoraria from the International Life Sciences Institute and The Coca Cola Company. Dr Lavie reports receiving consulting fees and speaking fees from The Coca-Cola Company….
• Comment: This is part of what appears to be a concerted effort by Coca-Cola to discredit NHANES, the national survey of dietary intake and disease risk that consistently associates soda intake to poor health.

A high-protein breakfast prevents body fat gain, through reductions in daily intake and hunger, in “Breakfast skipping” adolescents.  Heather J. Leidy, Heather A. Hoertel, Steve M. Douglas, Kelly A. Higgins and Rebecca S. Shafer.  Obesity.  Article first published online: 4 AUG 2015.  DOI: 10.1002/oby.21185

• Conclusions: The daily addition of a HP [high-protein] breakfast improved indices of weight management as illustrated by the prevention of body fat gain, voluntary reductions in daily intake, and reductions in daily hunger in breakfast skipping adolescents with overweight/obesity.
• Funding: The Pork Checkoff supplied the funds to complete the study.
• Disclosure: The authors declared no conflict of interest.
• Comment: Industry-funded investigators typically state that funding does not introduce conflicts of interest.

Breakfasts Higher in Protein Increase Postprandial Energy Expenditure, Increase Fat Oxidation, and Reduce Hunger in Overweight Children from 8 to 12 Years of Age.  Jamie I Baum, Michelle Gray, and Ashley Binns.  J. Nutrition.  First published August 12, 2015, doi: 10.3945/jn.115.214551  J. Nutr. jn214551

• Conclusion: This study indicates that breakfast macronutrient composition affects postprandial responses in both NW [normal weight] and OW [overweight] children. A PRO [protein-rich breakfast] increases postprandial EE [energy expendititure] and fat oxidation, reduces hunger, and increases satiety when compared with a carbohydrate-based breakfast.
• Funding: Supported by a grant from the Egg Nutrition Center/American Egg Board, Chicago, IL. The Egg Nutrition Center/American Egg Board was not involved in the design, implementation, analysis, or interpretation of the data.
• Author disclosures: JI Baum, M Gray, and A Binns, no conflicts of interest.
• Comment: These industry-funded investigators also deny that funding introduces conflicts of interest.

The Effect of Breakfast vs. No Breakfast on Brain Activity in Adolescents when Performing Cognitive Tasks, as Assessed by fMRI [functional magnetic resonance imaging].  Jonathan Fulford1, Joanna L Varley2 and Craig A Williams.   Nutritional Neuroscience 2015 epub ahead of print.

• Conclusion: Although no statistically significant (P > 0.05) improvement in task performance was determined, significantly higher activation was recorded in the frontal, premotor, and primary visual cortex areas in the breakfast trial relative to the fasting condition…Such a finding may have important implications in the examination of the role of diet, and specifically breakfast, in determining children’s performance within the school environment.
• Funding: A grant was received of £18,678.08 from Kellogg Marketing & Sales Company (UK) Ltd to cover MRI scanning costs. Otherwise the research was conducted with the support of internal institutional funds and the authors received no other direct or indirect support, with no further competing interests.
• Comment: Ordinarily I’m not concerned about food companies’ donating products to be tested but £18,678.08 seems noteworthy, especially since the only point of this study is to demonstrate that breakfast-eaters do better (higher brain activation even though no significant gain in task performance).

Suboptimal Serum α-Tocopherol Concentrations Observed among Younger Adults and Those Depending Exclusively upon Food Sources, NHANES 2003-2006. McBurney MI, Yu EA, Ciappio ED, Bird JK, Eggersdorfer M, Mehta S (2015). PLoS ONE 10(8): e0135510. doi:10.1371/journal.pone.0135510

• Conclusion: The prevalence of inadequate vitamin E levels is significantly higher among non-users of dietary supplements…Our findings provide evidence that most Americans have serum α-tocopherol levels below 30 μmol/L. The EAR [Estimated Average Requirement], epidemiological and randomized controlled studies all indicate that maintaining a serum α-tocopherol concentration of 30 μmol/L may have beneficial effects on mortality, cognitive function and reproduction [Note: “may” indicates that what follows is speculative].
• Funding: This statistical analysis of data collected by the Centers for Disease Control (CDC)…was supported by DSM Nutritional Products, a manufacturer of vitamin E. MM, EC, JB and ME are employees of DSM Nutritional Products. DSM Nutritional Products provided support in the form of salaries for authors MM, EC, JB, and ME and as an unencumbered gift to Cornell University that was used to support EY as a graduate research assistant.
• Competing interests: This study was supported by DSM Nutritional Products, a manufacturer of vitamins, including vitamin E, for food, dietary supplement, and pharmaceutical use. MM, EC, JB, and ME are employees of DSM Nutritional Products.
• Comment: Inadequate vitamin E in this study is defined as a serum level below a certain cut-point with uncertain clinical significance.  According to the Dietary Reference Intakes, clinical signs of vitamin E deficiency have not been observed in healthy populations.

Note: Since mid-March, I have posted 47 industry-funded studies with results favorable to food companies or trade associations, vs. 1 study with unfavorable results.

If you see industry-funded studies with results that must have made the sponsor unhappy, please send.

Don’t miss the article on the front page of today’s New York Times about Coca-Cola’s paying scientists who argue that obesity is more about exercise than diet (I’m quoted).

Last week, I posted two industry-funded studies with results that must have made their sponsors extremely unhappy.

But results like that are rare—so rare that the Washington Post wrote about one of them.

Today, I’m doing another in my series of posts of 5 (sometimes 6) studies sponsored by food and beverage companies for the purpose of obtaining results that can be used in marketing.

Since March, the count is 42 studies with results favorable to the sponsor but only 1 unfavorable (the other was from last year).

If you run across either kind, but especially industry-funded studies that don’t produce expected results, please send.

Dietary cholesterol and cardiovascular disease: a systematic review and meta-analysis. Berger, S., Raman, G., Vishwanathan, R., Jacques, P.F., Johnson, E.J., 2015. Am J Clin Nutr ajcn100305. doi:10.3945/ajcn.114.100305.

• Conclusion: Reviewed studies were heterogeneous and lacked the methodologic rigor to draw any conclusions regarding the effects of dietary cholesterol on CVD risk.  [Implication: suggestions that eggs might raise cardiovascular risk are unwarranted]
• Sponsor: Supported by USDA agreement 1950-51000-073 and the American Egg Board, Egg Nutrition Center.

Milk intake is not associated with low risk of diabetes or overweight-obesity: a Mendelian randomization study in 97,811 Danish individuals.  Helle KM Bergholdt, Børge G Nordestgaard, and Christina Ellervik.  Am J Clin Nutr.  doi: 10.3945/ajcn. 114.105049

• Conclusion: High milk intake is not associated with a low risk of type 2 diabetes or overweight-obesity, observationally or genetically via lactase persistence. The higher risk of type 2 diabetes in lactasepersistent individuals without milk intake likely is explained by collider stratification bias..
• Funding source: HKMB’s PhD project was partly funded by the Research Unit at Naestved Hospital, the Danish Dairy Research Foundation

Dietary Approaches to Stop Hypertension diet retains effectiveness to reduce blood pressure when lean pork is substituted for chicken and fish as the predominant source of protein. R Drew Sayer, Amy J Wright, Ningning Chen, and Wayne W Campbell. Am J Clin Nutr 2015; 102:302-308 doi:10.3945/ajcn.115.111757

• Conclusion: The results indicate that adults with elevated BP [blood pressure] may effectively incorporate lean pork into a DASH-style diet for BP reduction.
• Sponsor: This paper is sponsored by the national pork board.

Relationship between lifestyle behaviors and obesity in children ages 9-11: Results from a 12-country study. Katzmarzyk PT, Barreira TV, Broyles ST, Champagne CM, Chaput JP, Fogelholm M, Hu G, Johnson WD, Kuriyan R, Kurpad A, Lambert EV, Maher C, Maia J, Matsudo V, Olds T, Onywera V, Sarmiento OL, Standage M, Tremblay MS, Tudor-Locke C, Zhao P, Church TS; ISCOLE Research Group.

• Conclusion: Behavioral risk factors are important correlates of obesity in children, particularly low MVPA [moderate to vigorous physical activity], short sleep duration, and high TV viewing.  [Implication: what they eat and drink doesn’t matter]
• Sponsor: This research was supported by The Coca-Cola Company.

A systematic review of the cost and cost effectiveness of using standard oral nutritional supplements in community and care home settings. M. Elia, C. Normand, A. Laviano , K. Norman.  Clinical Nutrition 2015, online ahead of print. doi:10.1016/j.clnu.2015.05.010

• Conclusions: Overall, the reviewed studies, mostly based on retrospective cost analyses, indicate that ONS [oral nutritional supplement] use in the community produce an overall cost advantage or near neutral balance, often in association with clinically relevant outcomes, suggesting cost effectiveness. There is a need for prospective studies designed to examine primary economic outcomes.
• Authors’ disclosures: ME, CN and AL have received honoraria for giving independent talks at national/international conferences supported by industry. KN has received speakers’ fees as well as financial support for research projects by commercial companies.
• Comment: most studies of supplement use find little evidence of benefit.  Taking honoraria from industry doesn’t sound like much of a problem unless these financial ties are with supplement companies.  The authors do not specify and the journal’s editors must not require such specification.  They should.

As promised, I am posting examples of industry-sponsored research every time I collect five.  These, like the others, produce results favorable to the sponsor’s interests.

I am happy to post examples of sponsored studies that do not favor the sponsor’s interests, and this first one comes closest.  This Unilever-sponsored study found that consuming the product had no effect on blood flow in people with high blood cholesterol levels, although it did lower their levels of LDL (the “bad” cholesterol).

The effect of a low-fat spread with added plant sterols on vascular function markers: results of the Investigating Vascular Function Effects of Plant Sterols (INVEST) study. By Rouyanne T Ras, Dagmar Fuchs, Wieneke P Koppenol, Ursula Garczarek, Arno Greyling, Christian Keicher, Carole Verhoeven, Hakim Bouzamondo, Frank Wagner, and Elke A Trautwein.  Am J Clin Nutr 2015; 101:733-741 doi:10.3945/ajcn.114.102053.

• Conclusion: The intake of a low-fat spread with added PSs [plant sterols] neither improved nor worsened FMD [flow-mediated dilation]or other vascular function markers in hypercholesterolemic men and women. As expected, serum LDL cholesterol decreased, whereas plasma PSs increased after PS intake.
• Sponsor: Unilever Research and Development

The next four are more typical:

Dairy proteins, dairy lipids, and postprandial lipemia in persons with abdominal obesity (DairyHealth): a 12-wk, randomized, parallel-controlled, double-blinded, diet intervention study. By Mette Bohl, Ann Bjørnshave, Kia V Rasmussen, Anne Grethe Schioldan, Bashar Amer, Mette K Larsen, Trine K Dalsgaard, Jens J Holst, Annkatrin Herrmann, Sadhbh O’Neill, Lorraine O’Driscoll, Lydia Afman, Erik Jensen, Merete M Christensen, Søren Gregersen, and Kjeld Hermansen.  Am J Clin Nutr 2015; 101:870-878 doi:10.3945/ajcn.114.097923

• Conclusion:  We found that a whey protein supplement decreased the postprandial chylomicron response compared with casein in persons with abdominal obesity, thereby indicating a beneficial impact on CVD risk.
• Sponsor: Arla Foods Ingredients Group P/S, and the Danish Dairy Research Foundation, among some independent sources.

Policy Statement: Snacks, Sweetened Beverages, Added Sugars, and Schools. Council on School Health, Committee on Nutrition, American Academy of Pediatrics.  Pediatrics Volume 135, number 3, March 2015.

• Conclusion: A positive emphasis on nutritional value, variety, appropriate portion, and encouragement for a steady improvement in quality will be a more effective approach for improving nutrition and health than simply advocating for the elimination of added sugars.
• Conflicts reported: One of the members of the committee writing this statement is supported by the National Dairy Council and the American Dairy Association.  Another receives support from the Nestle Nutrition Institute.

Maternal long chain polyunsaturated fatty acid [omega-3] supplementation in infancy increases length- and weight-for-age but not BMI to 6 years when controlling for effects of maternal smoking. L.M. Currie, E.A. Tolley, J.M. Thodosoff, E.H. Kerling, D.K. Sullivan, J. Colombo, and S.E. Carlson . Prostaglandins, Leukotrienes and Essential Fatty Acids, 2015.  http://dx.doi.org/10.1016/j. plefa.2015.04.001

• Conclusion: Our results… suggest that LCPUFA [omega-3s] could have positive effects on stature without negative effects on weight status; and that LCPUFA could mitigate lower stature and higher BMI associated with maternal smoking, particularly in boys.
• Sponsor: Mead Johnson Nutrition, the maker of the LCPUFA omega-3 supplement

Mediterranean Diet and Age-Related Cognitive Decline:  A randomized Clinical Trial. Cinta Valls-Pedret, MSc; Aleix Sala-Vila, DPharm, PhD; Mercè Serra-Mir, RD; et al.  JAMA Intern Med. Published online May 11, 2015. doi:10.1001/jamainternmed.2015.1668.

• Conclusion: In an older population, a Mediterranean diet supplemented with olive oil or nuts is associated with improved cognitive function.
• Conflicts reported: Dr Salas-Salvado reports receiving research funding and is a nonpaid member of the scientific advisory committee of the International Nut Council. Dr Ros also reports receiving research funding and is a nonpaid member of the scientific advisory committee of the California Walnut Commission.

Let me comment on this last one, which may seem like pushing things, given that the study itself was funded by the agency for biomedical research of the Spanish government.  I would have left it off this list had I not read an article about it in the Wall Street Journal.

The Journal interviewed Dr. Ros, the lead author:

The diminished decline in cognitive function likely stems from the abundance of antioxidants and anti-inflammatory agents found in the supplemental foods…He recommends that, to decrease age-related cognitive delay, people should add 5 tablespoons of olive oil as a well as a handful of nuts a day into their diet.

But the Journal also interviewed a clinical neuropsychologist who was not involved in the study:

The changes observed in cognition were very small and didn’t actually show that those diets improved cognition, they just showed less decline. Based on the research…people shouldn’t rush out to buy lots of olive oil and nuts.

My point here is that the sole purpose of this study was to prove the health benefits of olive oil and nuts.  Yes, these are healthy foods, but so are many others.  Like virtually all such studies, this one seems designed to produce the desired answer.

On his Weighty Matters blog, Dr. Yoni Freedhoff explains how biases play out in supposedly unbiased research journals, in this case, the British Journal of Sports Medicine.  Dr. Freedhoff talks about the journal’s temporary withdrawal of a paper arguing that diet is more important than physical activity in weight loss on the grounds that the authors did not disclose conflicts of interest.  In contrast, an editorial arguing the opposite, by authors who also did not disclose conflicts, went unchallenged and was not withdrawn.

Dr. Freedhoff asks: “Are these sorts of conflicts important to disclose?”

On the basis of today’s and many other examples, my answer is an unqualified yes.

What is a poor eater to do?

The latest meta-analysis of the effects of saturated fat on heart disease finds—none.

This study, reported in the Annals of Internal Medicine (doi: 10.7326/M13-1788), examined the results of

• 32 observational studies involving 530 525 participants
• 17 observational studies involving 25 721 participants
• 27 randomized controlled trials involving 103 052 participants

The result?

Current evidence does not clearly support cardiovascular guidelines that encourage high consumption of polyunsaturated fatty acids and low consumption of total saturated fats. 

This meta-analysis follows an editorial in a Mayo Clinic publication (http://dx.doi.org/10.1016/j.mayocp.2013.11.006) by authors who argue that saturated fat is not the problem.  Carbohydrates (e.g., sugars) are the problem.  The authors argue:

• Effects of saturated fat on blood cholesterol are weak and transient.
• Meta-analyses have found a lack of an association between heart disease mortality and saturated fat intake.
• Stroke studies find that patients with stroke had eaten less saturated fat.
• Long-term studies find that people with the highest dairy consumption have the lowest mortality risk, and also low diabetes and heart disease.
• Dietary trials find trivial or no benefit at all from decreasing saturated fat and/or increasing intake of polyunsaturated fat.

On this basis, they say that advice to reduce intake of saturated fat is irrational.

The New York Times asked several experts for comment on the meta-analysis, among them Dr. Frank Hu of Harvard:

The single macronutrient approach is outdated…I think future dietary guidelines will put more and more emphasis on real food rather than giving an absolute upper limit or cutoff point for certain macronutrients…people should try to eat foods that are typical of the Mediterranean diet, like nuts, fish, avocado, high-fiber grains and olive oil.

Dr. Hu was referring to a large clinical trial (not included in the meta-analysis), which concluded that a diet with more nuts and extra virgin olive oil reduced heart attacks and strokes when compared with a lower fat diet with more starches.

The Times story contained a reminder that the American Heart Association issued dietary guidelines last year to “restrict saturated fat to as little as 5 percent of their daily calories, or roughly two tablespoons of butter or two ounces of Cheddar cheese for the typical person eating about 2,000 calories a day.”

How to make sense of this?

I vote with Frank Hu that dietary advice should focus on food, not nutrients.

Focusing on one or another nutrient—fat, saturated fat, cholesterol, or sugar—takes foods out of their caloric as well as dietary context.

My guess: If you balance food intake with physical activity and are not overeating, the specific proportion of fat, carbohydrate, and protein won’t matter nearly as much.

While the arguments about fat v. sugar go on and on:  Eat your veggies, vary the foods you eat, don’t gorge, and enjoy what you eat.