Here are three rare studies sponsored by food companies with results that must have disappointed their funders.  Since mid-March when I started this collection, these bring the score to 85:9 (studies with results favorable to the sponsor’s interests vs. those against).

Acute Cocoa Supplementation Increases Postprandial HDL Cholesterol and Insulin in Obese Adults with Type 2 Diabetes after Consumption of a High-Fat Breakfast.  Arpita Basu, Nancy M Betts, Misti J Leyva, Dongxu Fu, Christopher E Aston, and Timothy J Lyons.  J. Nutr. 2015; 145:2325-2332 doi:10.3945/jn.115.215772

• Conclusion: Acute cocoa supplementation showed no clear overall benefit in T2D [type 2 diabetes] patients after a high-fat fast-food–style meal challenge. Although HDL cholesterol and insulin remained higher throughout the 6-h postprandial period, an overall decrease in large artery elasticity was found after cocoa consumption.
• Funding: Supported by NIH Centers of Biomedical Research Excellence Program of the National Center for Research Resources at University of Oklahoma Health Sciences Center…a grant from The Hershey Company (to AB), and the Dean’s Research Incentive program in the College of Human Sciences at Oklahoma State University.

Associations between flavan-3-ol intake and CVD risk in the Norfolk cohort of the European Prospective Investigation into Cancer (EPIC-Norfolk).  Vogiatzoglou A¹, Mulligan AA², Bhaniani A², Lentjes MA², McTaggart A², Luben RN², Heiss C³, Kelm M³, Merx MW³, Spencer JP³, Schroeter H⁴, Khaw KT⁵,Kuhnle GG⁶.  ).  Free Radic Biol Med. 2015 Jul;84:1-10. doi: 10.1016/j.freeradbiomed.2015.03.005. Epub 2015 Mar 17.

• Conclusion:  There were no consistent associations between flavan-3-ol monomer intake and baseline systolic and diastolic blood pressure (BP)…Flavan-3-ol intake in EPIC-Norfolk is not sufficient to achieve a statistically significant reduction in CVD risk.
• Funding: The present study was supported by the EU (Grant 226588, “Flaviola”) and an unrestricted grant from Mars, Inc. Mars, Inc. had no role in the design and analysis of the study or in the writing of this article. EPIC-Norfolk is supported by Cancer Research UK (SP2024-0201 and SP2024-0204) and the Medical Research Council (G9502233). H.S. is employed by MARS, Inc., a member of the FLAVIOLA research consortium and a company engaged in flavanol research and flavanol-related commercial activities. None of the other authors has a conflict of interest to declare.
• Comment: This and the previous study are part of an effort to make chocolate seem like a health food.  Alas, these didn’t work.

No Change in 24-Hour Hydration Status Following a Moderate Increase in Fluid Consumption.  Matthew A. Tucker MA, J. D. Adams MS, Lemuel A. Brown MS, Christian B. Ridings MS, Jenna M. Burchfield MS, Forrest B. Robinson BS, Jamie L. McDermott MS, RD, LDN, Brett A. Schreiber MS, Nicole E. Moyen MS, Tyrone A. Washington PhD, Andrea C. Bermudez BS, Meredith P. Bennett BS, Maxime E. Buyckx MD & Matthew S. Ganio PhD.  Journal of the American College of Nutrition, DOI: 10.1080/07315724.2015.1046196.

• Conclusions: Regardless of fluid volume or beverage type consumed, measures of 24-hour hydration status did not differ, suggesting that standard measures of hydration status are not sensitive enough to detect a 22% increase in beverage consumption.
• Funding: This study was supported by a grant from The Coca-Cola Company. M.E.B., an employee of The Coca-Cola Company, contributed to study design and writing the article.
• Comment: Coca-Cola has long advertised its products as promoting hydration.  In most people, thirst and normal food intake take care of hydration.  This study confirms that if you drink more than you need, you pee out the excess.

These are coming in so quickly that I am having a hard time keeping up with them.  Note that the first three are sponsored by Coca-Cola and that some of the investigators were involved with the ill-fated Global Energy Balance Network, now defunct.  As we now know from the e-mails obtained by the Associated Press, the statement that “the sponsor played no role…” is not necessarily correct.

As for the score: since mid-March, I have collected 85 sponsored studies with results just as the sponsor wanted, versus 6 with results that must have disappointed.  But stay tuned: tomorrow I will post 3 more in the disappointing category.

Low levels of physical activity are associated with dysregulation of energy intake and fat mass gain over 1 year.  Robin P Shook, Gregory A Hand, Clemens Drenowatz, James R Hebert, Amanda E Paluch, John E Blundell, James O Hill, Peter T Katzmarzyk, Timothy S Church,11 and Steven N Blair.  Am J Clinical Nutrition November 11, 2015 as doi: 10.3945/ajcn.115.115360.

• Conclusions: These results suggest that low levels of physical activity are a risk factor for fat mass gain. In the current sample, a threshold for achieving energy balance occurred at an activity level corresponding to 7116 steps/d, an amount achievable by most adults.
• Funding: Supported by an unrestricted research grant from The Coca-Cola Company.

Association between cardiorespiratory fitness and submaximal systolic blood pressure among young adult men: a reversed J-curve pattern relationship. Vivek K. Prasada, Clemens Drenowatza, Gregory A. Handb, Carl J. Laviec, Xuemei Suia, Madison Demelloa, and Steven N. Blair.  Journal of Hypertension 2015, 33:2239–2244.

• Conclusions: There was a reverse J-curve pattern relationship between SSBP [submaximal systolic blood pressure] and CRF [cardiorespiratory fitness], with the lowest SSBP among men with fair or good CRF and highest among those with poor CRF.
• Funding: Funding for this project was provided through an unrestricted grant from The Coca-Cola Company. The sponsor played no role in the study design, data collection, analysis and interpretation, or preparation and submission of this manuscript.

Relation of Body’s Lean Mass, Fat Mass and Body Mass Index with Submaximal Systolic Blood Pressure Among Young Adult Men.  Vivek K. Prasad, MD, MPH, PhD, Clemens Drenowatz, PhD, Gregory A. Hand, PhD, Carl J. Lavie, MD, Xuemei Sui, MD, MPH, PhD, Madison Demello, MS, Steven N.Blair.  Am J Cardiology 2015 DOI: 10.1016/j.amjcard.2015.10.060 .

• Conclusion: there was a J curve pattern between SSBP [submaximal systolic blood pressure] and components of body composition whereas, a linear relation between SSBP and BMI.
• Funding: Funding for this project was provided through an unrestricted grant from the Coca-Cola Company. The sponsor played no role in the study design, data collection, analysis, and interpretation,or preparation and submission of this manuscript.

Sugar- and artificially sweetened beverages and intrahepatic fat: A randomized controlled trial. Vanessa Campos, Camille Despland, Vaclav Brandejsky, Roland Kreis, Philippe Schneiter, Arnaud Chiolero, Chris Boesch and Luc Tappy.  Obesity Volume 23, Issue 12, pages 2335–2339, December 2015.

• Conclusion: In subjects with overweight or obesity and a high SSB intake, replacing SSB with ASB decreased intrahepatic fat over a 12-week period.
• Disclosure:  LT received research support from Nestlé SA, Switzerland, and Ajinomoto Co Inc, Japan, for studies unrelated to this work and speaker’s honoraria from Nestlé SA, Switzerland, Ferrero, Italy, and C3 collaborating for health, UK. The other authors declared no conflict of interest.

Probiotic supplementation attenuates increases in body mass and fat mass during high-fat diet in healthy young adults. Kristin L. Osterberg, Nabil E. Boutagy, Ryan P. McMillan, Joseph R. Stevens, Madlyn I. Frisard, John W. Kavanaugh, Brenda M. Davy, Kevin P. Davy and Matthew W. Hulver.  Obesity Volume 23, Issue 12, pages 2364–2370, December 2015.  DOI: 10.1002/oby.21230.

• Conclusion: VSL#3 [the probiotic] supplementation appears to have provided some protection from body mass gain and fat accumulation in healthy young men consuming a high-fat and high-energy diet.
• Funding agencies: This study was funded by VSL Pharmaceuticals, Inc.
• Disclosure: The authors declared no conflict of interest.

Susannah Worth.  Digesting Recipes: The Art of Culinary Notation.  Zero Books, 2015.

I did a blurb for this unusual book:

Digesting Recipes takes an off-beat and highly refreshing post-modern look at cookbooks as markers of cultural identity.  Recipes, it makes clear, are far more than cooking directions.  After reading this, I have a whole new appreciation for what recipes can tell us about the deeper meanings of modern society.

It’s been a tough month for the soda industry.

• Yesterday, members of Mexico’s Nutritional Health Alliance held a press conference to complain that a Coca-Cola Christmas television ad violated the human rights of the indigenous people of the Mixe community of Totontepec.
  

  The ad, released by Coca-Cola in late November on social media as part of its “OpenYourHeart” Christmas advertising campaign shows young people who are outsiders to the Mixe indigenous community arriving to build a Christmas tree of wood and Coca-Cola bottle caps, distributing Coca-Cola to young people from the community and transmitting the message “Stay United” in the Mixe language.

  Coca-Cola removed the ad from its social media channels, but you can watch a version produced by the Alliance in which Mixe youth comment on the ad. The Alliance also has produced a translation.

Al Jazeera produced a video analysis.

• On November 6, the New York Times reported that the University of Colorado was returning a million dollar grant that had paid for the Global Energy Balance Network (GEBN), the group funded by Coca-Cola that said you didn’t need to worry about what you ate as long as you were active.
• On November 24, AP reporter Candice Choi published e-mails between the U. Colorado scientist behind the GEBN.  These revealed that “Coke helped pick the group’s leaders, edited its mission statement and suggested articles and videos for its website.”
• Coca-Cola’s chief scientist, Rhona Applebaum, immediately resigned.
• On November 29, Helena Bottemiller Evich wrote in Politico how health advocates are running endless campaigns for so taxes, and that these will soon be coming to a polling place near you.
• On November 30, the UK’s Commons Health Committee called for a 20% tax on sugar-sweetened beverages.
• On December 1, the GEBN closed shop as a result of loss of funding.
• This week’s issue of The Lancet Diabetes and Endocrinology contains an opinion piece by U North Carolina professor Barry Popkin and Corinna Hawkes of City University London arguing that the world is eating too much sugar and that changes in policy are needed to encourage reduced consumption of sugary drinks.  According to Politico Morning Agriculture, the American Beverage Association (ABA) is most unhappy about the piece.  It claims that the prevalence of obesity and diabetes are rising but soft drink sales are falling in the U.S., saying “This proves that beverages are not driving these epidemics.”  [Comment: as I discuss in Soda Politics, only half the population drinks sugary beverages meaning that those who do drink them drink a lot.  Also, diabetes rates are falling in the U.S.]
• The ABA won a battle in San Francisco, but is surely losing the public relations war.  It sued the city over a Board of Supervisors ban on ads for sugary drinks on city property and requiring warning labels on all billboards and other surfaces within the city.  The ABA argued that both laws violate the First Amendment.  You might think this argument would get thrown out of court immediately, but you would be wrong, as the Supreme Court is becoming more hostile to such laws.  If you want to hear how the Board of Supervisors reacted to this, click here for the meeting transcript. (thanks to Politico Morning Agriculture for this item too and to Michele Simon for clarifying the legal issues).

I keep getting asked “why pick on sodas?”  The answer: they are an easy target, low-hanging fruit in public health terms.  They contain sugars but nothing else of redeeming nutritional value, are strongly associated with diets that raise the risk of obesity and its consequences, and are heavily marketed as what you need to be happy.  The industry is fighting hard and on many fronts to maintain sales.  Advocates are keeping its lawyers and lobbyists busy.

All this was just in the last month.  Expect more to come.

Let’s take a look at a rare industry-funded study with results contrary to the interests of the funders.

It addresses the question: Is naturally occurring trans fat from meat and dairy products healthier than industrially produced trans fat?

The answer: not really.

The study

Vaccenic acid and trans fatty acid isomers from partially hydrogenated oil both adversely affect LDL cholesterol: a double-blind, randomized controlled trial.  Sarah K Gebauer, Frédéric Destaillats, Fabiola Dionisi, Ronald M Krauss, and David J Baer.  Am J Clin Nutr, November 11, 2015,  doi: 10.3945/ajcn.115.116129.

• Conclusions: Total cholesterol (TC), LDL cholesterol, triacylglycerol, lipoprotein(a), and apolipoprotein B were higher after VA [vaccenic acid] than after iTFA [industrial trans fatty acids]; high-density lipoprotein (HDL) cholesterol and apolipoprotein AI also were higher after VA. Compared with control, VA and iTFA both increased TC, LDL cholesterol, ratio of TC to HDL cholesterol, and apolipoprotein B…VA also increased HDL cholesterol, apolipoprotein AI, apolipoprotein B, and lipoprotein(a)…whereas iTFA did not. c9,t11-CLA [conjugated linoleic acid] lowered triacylglycerol…and had no effect on other lipoprotein risk factors.
• Funding:  Supported by USDA, Dairy Management Inc., Nestlé, and Dairy Australia. The funding organizations had no role in the conduct of the study; collection, management, analysis, and interpretation of the data; or decision to submit the manuscript for publication.

Background

Everyone agrees that hydrogenated fats containing trans fatty acids (industrial trans fatty acids or iTFAs) raise the risk of LDL-cholesterol (the bad one) and, therefore, the risk of coronary artery disease.  But what about the naturally occurring trans fats that occur in meat and dairy products as a result of bacterial hydrogenation of fats in the rumens of ruminant animals (ruminant trans fatty acids or rTFAs)?

Some studies suggest that rTFAs do not raise the risk of coronary disease.  This study tests that hypothesis.  It found that the major rTFA, vaccenic acid, does indeed raise risk factors for coronary artery disease almost or more than do iTFAs.

To make sense of the study, you need to know:

• In iTFAs, the two major trans fats are elaidic acid 25%, and vaccenic acid 10%
• In rTFAs, the trans fats are vaccenic acid 45% and elaidic acid 5%
• Therefore, vaccenic acid is the major trans fat in rTFAs

What about Conjugated Linoleic Acid (CLA, or rumenic acid)?

The study also looked at intake of another rTFA, conjugated linoleic acid, which seems to have more benign properties but is present in such small amounts that it hardly makes a difference.  Although this study found CLA to have no effect on risk factors for coronary heart disease, a study from independently funded investigators judged it to have effects similar to that of other rTFAs.

What took so long to get this study published?

David Baer, who works for USDA, is the senior author on this paper.  I saw a slide presentation he did on this study in 2010.  Its results were already available.

In 2011, his group wrote a review of ruminant trans fats, but did not report these results (they were known, but not published).

In 2012, Dr. Baer wrote about ruminant trans fats, disclosed his dairy industry funding, but also did not report these results.  He concluded:

It is still difficult to draw definitive conclusions about the role of rTFAs in modulating risk of cardiovascular disease as mediated through changes in LDL and HDL cholesterol. Intake of these fatty acids is typically low in the diet.

I heard about this study last summer and wondered whether its funders were holding up publication.  I called Dr. Baer and asked.  He said the funders had nothing to do with the delay.  Instead, life had intervened—collaborators left, he was busy with other things, and was having trouble getting the paper published.

The bottom line

The study was done with purified vaccenic acid, not dairy fat, in amounts higher than those likely to be consumed in diets.  The authors say

Evidence…suggests that VA [vaccenic acid] consumed in amounts and foods typically found in the diet is inversely or not associated with CVD risk.

That’s one possible interpretation, but check the title of the editorial accompanying the paper: “In equal amounts, the major ruminant trans fatty acid is as bad for LDL cholesterol as industrially produced trans fatty acids, but the latter are easier to remove from foods.”

The funders of this study must be disappointed.  It was undoubtedly difficult and expensive to do, since it involved synthesis of pure vaccenic acid and a clinical trial of more than 100 subjects.

The funders must have hoped the study would show vaccenic acid to be as benign or even healthier than conjugated linoleic acid.  They bet wrong on this one.

This brings the score to 80:7 (sponsored studies with results favorable to the sponsor vs. those unfavorable).

In case you haven’t been following this saga, I’ve been collecting studies funded by food companies since last March and posting them according to whether the results do or do not favor the sponsor’s interests.  So far, I’ve reported 80 that do, versus 6 that don’t (although I have a couple more saved up for posting soon).

The point of this exercise is to demonstrate that sponsored studies are far more likely to favor the interests of the sponsor than are studies funded by government agencies or foundations, and to argue for more independent funding of food and nutrition research (see my recent Viewpoint on this topic in JAMA Internal Medicine).

Here are five more examples.

Is consuming yoghurt associated with weight management outcomes? Results from a systematic review. J Eales, I Lenoir-Wijnkoop, S King, H Wood, F J Kok, R Shamir, A Prentice, M Edwards, J Glanville, R L Atkinson. Int’l J Obesity 2015 ahead of print.

• Conclusions: Yoghurt consumption is associated with lower BMI, lower body weight/weight gain, smaller waist circumference and lower body fat in epidemiological studies. RCTs [randomized controlled trials] suggest weight reduction effects, but do not permit determination of a cause/effect relationship. Well-controlled, adequately powered trials in research and community settings appear likely to identify a modest but beneficial effect of yoghurt consumption for prevention of weight gain and management of obesity. The ready availability of yoghurt (a nutrient dense food) and its ease of introduction to most diets, suggests that educating the public to eat yoghurt as part of a balanced and healthy diet may potentially contribute to improved public health.
• Funding: This project was funded by Danone Institute International.
• Conflict of interest statement: York Health Economics Consortium received funding from Danone Institute International to conduct this review. York Health Economics Consortium has received funding from the Global Alliance for Probiotics, Danone and the European Food Safety Agency for projects involving food and health topics. FJK is member of the Scientific Advisory Board Global Dairy Platform, Chicago USA RS is President of Danone Institute International ILW is employed by the Danone Company, France.

Red Meat and Colorectal Cancer: A Quantitative Update on the State of the Epidemiologic Science.  Dominik D. Alexander PhD, MSPHab*, Douglas L. Weed MD, PhDc, Paula E. Miller MPHb & Muhima A. Mohamed M PHd. J Am College Nutrition 2015;34: 521-43.  DOI:10.1080/07315724.2014.992553

• Conclusion:  The state of the epidemiologic science on red meat consumption and CRC [colorectal cancer] is best described in terms of weak associations, heterogeneity, an inability to disentangle effects from other dietary and lifestyle factors, lack of a clear dose-response effect, and weakening evidence over time.
• Funding: This manuscript was partially funded by Meat & Livestock Australia (MLA). MLA did not contribute to the writing, analysis, or interpretation of study findings.
• Comment: The conclusion of this industry-funded study contradicts the findings of the WHO International Agency for Research on Cancer, which finds processed meats to be carcinogenic, and red meat to be a probable carcinogen.

The challenges of nutrition policymaking. Joanne Slavin.  Nutrition Journal (2015) 14:15 DOI 10.1186/s12937-015-0001-8.

• Thrust of paper: As every DGAC [Dietary Guidelines Advisory Committee] wants to be bold and set new direction, nutrition science would support that first we must do no harm with our dietary guidance. Moderation and variety must be kept front and center…A suggestion that all Americans should reduce sodium intakes is not sound and is potentially dangerous. Targeting certain foods and beverages, including chocolate milk, processed meats, added sugars, and even the noble potato as villains in the nutrition wars is not a science-based strategy and may need to be countered on the political front if appointed scientific review committees continue to take this approach.
• Competing interests: In the past 5 years Dr. Slavin has received research grants from Minnesota Beef Council, Minnesota Cultivated Wild Rice Council, Novartis Consumer Health, USA Rice, Nestle Nutrition, Tate and Lyle, General Mills, Inc., USA Pears and American Pulse Association. In the past 5 years Dr. Slavin has received speaking fees from food companies and commodity groups with interests in processed foods, dairy products, meat, pulses, fruits, vegetables, fiber, grains, and carbohydrates. Dr. Slavin has participated in scientific panels and advisory boards that are funded by food companies, ingredient companies, commodity groups, scientific societies, and trade groups. She holds a third interest in the Slavin Sisters LLC, a 119-acre farm in Southern Wisconsin.

Does low-energy sweetener consumption affect energy intake and body weight? A systematic review, including meta-analyses, of the evidence from human and animal studies PJ Rogers, PS Hogenkam , C de Graaf, S Higgs, A Lluch, AR Ness, C Penfold, R Perry, P Putz, MR Yeomansand DJ Mela.International Journal of Obesity (2015), 1–14 10 November 2015; doi:10.1038/ijo.2015.177

• Conclusions: Overall, the balance of evidence indicates that use of LES [low-energy sweeteners] in place of sugar, in children and adults, leads to reduced EI [energy intake] and BW [body weight], and possibly also when compared with water.
• Conflict of interest: Peter J Rogers has received grants from Sugar Nutrition, UK in support of research on the effects of sugar on human appetite. Cees de Graaf has received grants from the Dutch Sugar Bureau in support of a study on brain responses to sugars and low energy sweeteners. Suzanne Higgs has received a grant from Canderel in support of research on the effects of low-energy sweeteners on human appetite. Anne Lluch and David J Mela are employees and shareholders of companies that manufacture products containing sugars and low-energy sweeteners. Peter Putz is an employee of ILSI Europe.

Walnut ingestion in adults at risk for diabetes: effects on body composition, diet quality, and cardiac risk measures Valentine Yanchou Njike, Rockiy Ayettey, Paul Petraro, Judith A Treu, David L Katz.  . BMJ Open Diabetes Research and Care 2015;3:e000115. doi:10.1136/bmjdrc-2015- 000115.

• Conclusions: The inclusion of walnuts in an ad libitum diet for 6 months, with or without dietary counseling to adjust calorie intake, significantly improved diet quality, endothelial function, total and LDL cholesterol, but had no effects on anthropometric measures, blood glucose level, and blood pressure.
• Funding: Funding for this study has been provided by the California Walnut Commission.
• Competing interests. DLK has been compensated for public speaking by the California Walnut Commission.

The CDC’s latest update on the food safety problems at Chipotle says whatever food or ingredient caused 45 people to become ill with E. coli is still unknown.

Bill Marler, the food safety attorney who tracks such things, offers a history of previous Chipotle outbreaks from 2008-2015; these involved Norovirus, Salmonella, hepatitis A, campylobacter, and now an STEC (Shiga Toxin-Producing E. coli).

Chipotle closed some of its outlets in the Northwest, but then reopened.

Steve Ells, Chipotle’s CEO, placed an ad in the New York Times, promising to do everything possible to prevent this from happening again.

This got Bill Marler to ask: Is this Chipotle’s 2-b-4 moment?

We only make dramatic changes when we’ve been hit in the head with a 2-by-4 once or twice. Hopefully for Chipotle, this is their 2-by-4 moment.

The presence of E. coli indicates fecal contamination of some ingredient or food that was not cooked or not cooked sufficiently (cooking kills bacteria).  But from what animal,where, and when?

Chipotle needs to check every ingredient it sources, as well as every process involved in preparing and serving the foods.  If standard safety procedures aren’t already in place, this is a big job.

Let’s hope the CDC finds out what caused this outbreak, and soon.

Kima Cargill.  The Psychology of Overeating: Food and the Culture of Consumerism.  Bloomsbury, 2015.

I did a blurb for this one:

Psychologist Kima Cargill takes a tough, critical look at today’s consumerist culture from the perspective of research as well as of observations drawn from her clinical experience with patients struggling with weight issues. To stop overeating in today’s food environment means finding effective ways to counter the many moral, political, economic, and social imperatives to consume. The ideas in this book should inspire readers to think of obesity in an entirely different way—more as the result of a consumerist society than of individual weakness.