Currently browsing posts about: Sponsored-research

In FoodNavigator, I read a report of a study finding that processing of corn into breakfast cereal flakes strips out phenolic compounds and tocopherols (vitamin E) associated with good health.

Just as processing of whole wheat into white flour removes the bran and germ, so does the processing of corn into corn flakes.

The germ and bran (hull) layers of grain seeds contain the vitamins and minerals—and the phenolics.  What’s left is the starch and protein (endosperm).

To replace these losses, manufacturers fortify corn flakes with 10% to 25% of the Daily Value for 12 vitamins and minerals.

This study is further evidence for the benefits of consuming relatively unprocessed foods.

Of particular interest to me is the authors’ disclosure statement:

This work was funded in part through gifts from the Kellogg Company and Dow AgroSciences.

The authors declare no competing financial interest.

This makes this study a highly unusual example of an industry-funded study with a result unfavorable to the sponsor’s interests.  The authors do not perceive Kellogg funding as a competing interest.  It is.  Kellogg (and maybe Dow) had a vested interest in the outcome of this study.

I would love to know whether these authors obtain further research grants from Kellogg and Dow.

As I discuss in my latest book, Unsavory Truth: How Food Companies Skew the Science of What We Eat, food industry funding of nutrition research produces highly predictable results and, therefore, is not good for science, public health, or trust.

Industry-funded studies are easily recognizable by their titles.  When I see a title like this one, I immediately wonder why anyone would do a study to example this particular question.  And then I look to see who funded it.

Title: Corn Oil Lowers Plasma Cholesterol Compared with Coconut Oil in Adults with Above-Desirable Levels of Cholesterol in a Randomized Crossover Trial. J Nutr 2018 148(10):1556-63.

Conclusion: “When incorporated into the habitual diet, consumption of foods providing ∼54 g of corn oil/d produced a more favorable plasma lipid profile than did coconut oil in adults with elevated cholesterol.”

Sponsor: “Supported by ACH Food Companies, Inc., Oakbrook Terrace, IL,” and all of the authors either received research funding from ACH Food Companies, Inc., or are employees of that company.

Comment: So what is this about?  ACH is the maker of Mazola oil, which must be losing market share to coconut oil.

Which oil is better for you and does it really matter?

I sure would like some independent researchers to weigh in on this.

My latest book, Unsavory Truth: How Food Companies Skew the Science of What We Eat, is about food industry funding of nutrition research and why it’s not good for science, public health, or trust.

The book is full of examples, easily recognized by their titles.

I can’t resist showing you the latest example:

The title: Vitamin-supplemented chewing gum can increase salivary and plasma levels of a panel of vitamins in healthy human participants.  Journal of Functional Foods Volume 50, November 2018, Pages 37-44.

The conclusion: “our study demonstrates the potential usefulness of chewing gum as a delivery vehicle for both water- and fat-soluble vitamins.”

Guess who funded this study?  “This work was supported by Vitaball, Inc. (FT. Thomas, KY, USA) and the United States Department of Agriculture.”

Vitaball, you can probably guess, makes vitamin-fortified chewing gum, and one of the study’s authors works for the company.

Want vitamins?  Try food.

With all of the talk these days about avoiding ultraprocessed foods, questions come up about what that means.  After I posted about the added colors involved in processing plant-based meats, I received a tweeted question:

This got me thinking about tofu. Is it highly processed? Love your thoughts on it!

Like everything else about nutrition, the answer depends—in this case about what you consider processing.  All foods are processed to some extent, if you count washing and cutting.

Ultraprocessing, however, refers to foods that look nothing like what they started out as, and are loaded with added sugars, salt, and artificial colors and flavors.

Commercial tofu is minimally processed; it is just soybeans and a coagulating agent.  Here is one recipe, for example:

• Soak the soybeans: in water to soften them for 12 to 14 hours.
• Process the beans to a slurry.
• Boil the slurry to inactivate lectins and other undesirable soy compounds.
• Extract the soy liquid (“milk”) with a roller press to separate it from the soybean pulp.
• Mix a coagulating agent—calcium sulfate, magnesium chloride, or nigari.—into the soy milk.
• Press the liquid out of the curds.

The tofu you might make at home seems minimally processed, as it is made from just commercial soymilk and lemon juice.  Commercial soymilk, however, contains far more than just soybean liquid:

INGREDIENTS: Soymilk (Filtered Water, Soybeans), Cane Sugar, Contains 2% or less of: Vitamin and Mineral Blend (Tricalcium Phosphate, Calcium Carbonate, Vitamin A Palmitate, Vitamin D2, Riboflavin [B2], Vitamin B12), Sea Salt, Natural Flavor, Gellan Gum.

I consider good-quality commercial tofu to be minimally processed.  Commercial soymilk is another matter.  Sugar is its second ingredient.  Gellan Gum is its last ingredient.

I wasn’t familiar with Gellan Gum, but I love the Wikipedia definition: “a water-soluble anionic polysaccharide produced by the bacterium Sphingomonas elodea (formerly Pseudomonas elodea),” that substitutes for agar and carrageenan.

A 1988 study of its effects on humans concluded that “the ingestion of gellan gum at a high level for 23 days caused no adverse dietary or physiological effects in any of the volunteers.”  No surprise here: Financial support for the study came from Kelco, Inc., a company that supplies Gellan Gum.

If you want your tofu unsweetened and minimally processed, buy a freshly made commercial variety.

Last week, New York Times reporter Roni Rabin wrote how the National Institutes of Health (NIH) solicited funding from alcohol companies to fund—and, distressingly, participate in the design of—a study of the effects of moderate drinking on heart disease risk.

This is not the first time Ms. Rabin has written about this study.  In July, she described the study and its funding.

Since then, she has apparently been busy filing FOIA requests and conducting further interviews.  These reveal that the NIH actively solicited industry funding and input into this trial.

The [NIH] presentations gave the alcohol industry an opportunity to preview the trial design and vet the investigators. Indeed, the scientist leading the meetings was eventually chosen to head the huge clinical trial.

They also made the industry privy to pertinent details, including a list of clinical sites and investigators who were “already on board,” the size and length of the trial, approximate number of participants, and the fact that they could choose any beverage. By design, no form of alcohol — wine, liquor or beer — would be called out as better than another in the trial.

But it gets worse.  Boston University professor Michael Siegel tells his personal story of dealings with NIH’s National Institute of Alcohol Abuse and Alcoholism (NIAAA)

On January 16, 2015, I was called into the office of the Director of NIAAA and was essentially reprimanded for conducting NIAAA-funded research that was detrimental to the alcohol industry…At the meeting, I was told that I would never again be funded to conduct research on alcohol marketing, regardless of how highly my research proposal was scored by the scientific review panel.

Let me be clear: research ethics require funders to have no involvement in research design, conduct, or interpretation, lest they exert undue influence on the results.

Julia Belluz (Vox) put this study in context.  She describes how

The NIH is now investigating whether the researchers violated federal policy by soliciting donations, and they’re appointing outside experts to review the design of the study. We don’t yet know the full story, and there’s surely more to uncover.

Anheuser Busch InBev, Heineken, Diageo, Pernod Ricard, and Carlsberg helped pay $67.7 million of the $100 million government study, which is currently underway. And even more troubling is that if you were a patient looking to enroll in the trial through the online clinical trials registry, you’d have no way of knowing about the industry’s involvement because that funding is not disclosed there.

Although I do not have much to say about the alcohol industry in my forthcoming book, Unsavory Truth: How Food Companies Skew the Science of What We Eat, I mention of this study as an example of how other industries skew research and also how pooling industry research funds is insufficient protection against conflicted interests (alcohol companies agreed to contribute 67.7% of the funding).

It’s good that the NIH has decided to investigate this dubious government-industry partnership, which so clearly seems aimed at marketing, not public health.

I haven’t posted an industry-funded study with predictable results in a while but when I saw this headline from FoodNavigator-Asia, I couldn’t resist.

The headline: “The most important meal of the day: Daily breakfast may lower obesity risk in schoolchildren — Nestlé study.”

High marks to FoodNavigator-Asia for naming the funder in the headline.

Its article referred to this study:

Breakfast consumption among Malaysian primary and secondary school children and relationship with body weight status – Findings from the MyBreakfast Study, by E Siong Tee, Abdul Razak Nurliyana,  A Karim Norimah, Hamid Jan B Jan Mohamed , Sue Yee Tan, Mahenderan Appukutty, Sinead Hopkins, Frank Thielecke, Moi Kim Ong, Celia Ning, Mohd Taib Mohd Nasir.  Asia Pacific Journal of Clinical Nutrition 2018;27(2):421 – 432.

Purpose: To determine the relationship between breakfast consumption and body weight status among primary and secondary school children in Malaysia among 5,332 primary school children aged 6 to 12 years and 3,000 secondary school children aged 13 to 17 years.

Results: “The proportion of overweight/obesity was higher among breakfast skippers (boys: 43.9%, girls: 30.5%) than regular breakfast eaters (boys: 31.2%, girls: 22.7%)…. Compared to regular breakfast eaters, primary school boys who skipped breakfast were 1.71 times (95% CI=1.26-2.32, p=0.001) more likely to be overweight/obese, while the risk was lower in primary school girls (OR=1.36, 95% CI=1.02-1.81, p=0.039) and secondary school girls (OR=1.38, 95% CI=1.01-1.90, p=0.044).”

Conclusion: “Regular breakfast consumption was associated with a healthier body weight status and is a dietary behaviour which should be encouraged.”

Author disclosures: “This study was funded by Cereal Partners Worldwide (CPW), Lausanne, Switzerland and Nestlé R&D Center, Singapore. Sinead Hopkins and Frank Thielecke were working for CPW, Lausanne, Switzerland, and Moi Kim Ong and Celia Ning were working for Nestlé R&D Center, Singapore, when the study was conducted. All authors declare that they have no conflicts of interests.”

I was particularly interested in this study for several reasons:

• Cereal Partners Worldwide is a joint venture between Nestlé and General Mills.  They have an interest in promoting breakfast cereals.
• Nevertheless, the authors who work for CPW or Nestlé believe that their employment with companies with vested interests in the outcome of research creates no conflict of interest.
• Breakfast, as Julia Belluz of Vox puts it, is often dessert in disguise.
• This particular study was performed by some of the same investigators discussed in the New York Times as part of its Planet Fat series.  See: Fuller T, O’Connor A, Richtel M.  In Asia’s fattest country, nutritionists take money from food giants.  NY Times, Dec 23, 2017.

No, I do not believe that breakfast is the most important meal of the day (I’m not much of a breakfast eater).  Eat when you feel hungry.

It does make sense to think that children should be fed at regular intervals and should not go to school hungry.  It also makes sense that regular meals encourage healthier patterns.  But preventing obesity?  That seems like a stretch, especially when the study’s funders have a financial interest in selling breakfast cereals.

Since it’s Valentine’s Day (have a happy one), we might as well talk about a candy company, in this case, Mars, Inc.

Mars, Inc., one of the defectors from the Grocery Manufacturers Association (see yesterday’s post) has also withdrawn from membership in and support of the International Life Sciences Institute (ILSI), a group that claims to be independent  but in fact is funded by hundreds of food and beverage companies (hence: front group).

ILSI’s positions on food issues are decidedly pro-industry, and so are the results of its sponsored research.  Mars couldn’t take it anymore.

Mars told Politico Pro (this may be behind a paywall):

After careful consideration, Mars will end its relationship with the International Life Sciences Institute (ILSI) by the end of 2018, and is withdrawing from ILSI’s nutrition committees immediately,” the company said in a statement to POLITICO. “Increasingly, the presentation of certain studies by ILSI has been at odds with our position and principles. Mars has a long history of engaging in external research that is evidence-based and data-driven, particularly in the area of promoting public health. We wish to thank ILSI for its partnership.

Mars announces this departure as a component of its new research and engagement policy.

The policy applies to all of Mars’ partnerships with universities, governmental and non-governmental organizations, foundations, individuals, food companies, and trade associations (like ILSI).

Here is my summary of the policy’s long list of principles:

• High scientific standards in all animal and human research
• Full disclosure of funding and potential conflicts of interest
• Appropriate standards of authorship
• Funding not linked to achievement of a specific research outcome

For months now, I haven’t posted an industry-funded studies with results favorable to the sponsor, but this one about deserves mention.

Title: Critical review of the current literature on the safety of sucralose, by BA Magnuson, A Roberts, and ER Nestmann.

Journal: Food and Chemical Toxicology 2017:106:324-355.

Conclusion: “Collectively, critical review of the extensive database of research demonstrates that sucralose is safe for its intended use as a non-caloric sugar alternative.

Financial support was provided by the Calorie Control Council, Atlanta GA, to the employers of the authors for the preparation and publication of this review.

My comment: This lengthy review of literature on the safety of sucralose (Splenda) was commissioned by the Calorie Control Council, a trade association representing “manufacturers and suppliers of low- and reduced-calorie foods and beverages, including manufacturers and suppliers of more than two dozen different alternative sweeteners, fibers and other low-calorie, dietary ingredients.”

It paid authors affiliated with Health Science Consultants, Inc and Intertek Scientific and Regulatory Consultancy to produce this review.

• The Calorie Control Council has a vested interest in demonstrating Splenda to be safe.
• The consultant groups have a vested interest in pleasing the Calorie Control Council.
• Therefore, this review has a higher-than-average likelihood of bias.

Is Splenda safe?  It very well may be safe, but some contrary evidence exists (this paper dismisses it).  It would be interesting to see how independent scientists view the matter.