Search results: american journal of clinical nutrition

Yesterday I reported about the COSMOS clinical trial demonstrating reductions in mortality among people taking cocoa flavanol supplements.

That trial had another arm: multivitamin supplements.

The study: Multivitamins in the Prevention of Cancer and Cardiovascular Disease: The COSMOS Randomized Clinical Trial.  Sesso HD et al.  The American Journal of Clinical Nutrition, nqac056, https://doi.org/10.1093/ajcn/nqac056

Conclusion: The supplements did not reduce cardiovascular disease, cancer, or all-cause mortality in older men and women.

Funding: The COcoa Supplement and Multivitamin Outcomes Study (COSMOS) is supported by an investigator-initiated grant from Mars Edge, a segment of Mars dedicated to nutrition research and products, which included infrastructure support and the donation of study pills and packaging. Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) provided support through the partial provision of study pills and packaging.

Conflicts of interest: Drs. Sesso and Manson reported receiving investigatorinitiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging,
Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) for donation of COSMOS study pills and packaging during the conduct of the study. Dr. Sesso additionally reported receiving investigator-initiated grants from Pure Encapsulations and Pfizer Inc. and honoraria
and/or travel for lectures from the Council for Responsible Nutrition, BASF, NIH, and American Society of Nutrition during the conduct of the study. No other authors reported any conflicts of interest.

Comment: Pfizer, of course, makes Centrum multivitamin supplements aimed at older adults.

I was surprised by this part of the trial because previous studies have also shown no consistently beneficial effect of supplementation of individual vitamins or multivitamins on disease risk.  Pfizer must have hoped to find benefits for Centrum.  This is a rare industry-supported study that showed no benefits and is, therefore, worth attention.

I learned about this one from a PR tweet from @Brigham Research: “Dr. JoAnn Manson…& colleagues report the main findings of the first ever randomized trial of a cocoa flavanol supplement on cardiovascular disease endpoints.”

Its spectacular results:  Supplementation with cocoa flavanols led to a 27% reduction in deaths from cardiovascular disease among all participants taking the supplement, and a 39% reduction in those deaths when they excluded participants who did not take the pills properly.

From taking cocoa flavanol supplements?

Who paid for this?

Bingo.

The study (still in preprint): Effect of Cocoa Flavanol Supplementation for Prevention of Cardiovascular Disease Events: The COSMOS Randomized Clinical Trial.  Sesso HD, et al.  American Journal of Clinical Nutrition, nqac055, https://doi.org/10.1093/ajcn/nqac055

Conclusion: “Cocoa extract supplementation did not significantly reduce total cardiovascular events among older adults but reduced CVD death by 27%….”

Funding: “The Cocoa Supplement and Multivitamin Outcomes Study (COSMOS) is supported by an investigator-initiated grant from Mars Edge, a segment of Mars dedicated to nutrition research and products, which included infrastructure support and the donation of study pills and packaging…[and other sources].

Conflicts of interest: Drs. Sesso and Manson reported receiving investigatorinitiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging,
Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) for donation of COSMOS study pills and packaging during the conduct of the study. Dr. Sesso additionally reported receiving investigator-initiated grants from Pure Encapsulations and Pfizer Inc. and honoraria
and/or travel for lectures from the Council for Responsible Nutrition, BASF, NIH, and American Society of Nutrition during the conduct of the study. No other authors reported any conflicts of interest.

Comment: Déjà vu all over again.

Mars, as I described in detail in Unsavory Truth, has been trying to make you think that chocolate is a health food (M&Ms!) for decades. It created a special brand, CocoaVia, for this purpose.  Here is an excerpt:

In 1982, Mars established a chocolate research center in Brazil.[i]  Its scientists were particularly interested in cocoa flavanols, a category of flavonoids with antioxidant, anti-inflammatory, and other heart-healthy effects.  Through the 1980s and 1990s, Mars’ scientists produced studies suggesting such benefits.

Alas, cocoa flavanols come with complications.  They taste bitter (dark chocolate contains more of them).  They are present in such small amounts that you would have to eat a quarter to a full pound of chocolate a day to achieve cardiovascular benefits.[ii]  Worse, they are destroyed by traditional chocolate processing.[iii]  The losses may explain why a Hershey-funded clinical trial failed to find neuropsychological or cardiovascular benefits from eating dark chocolate when compared to a placebo.[iv]

But to return to CocoaVia: Mars developed a process to preserve the cocoa flavanols during processing, and combined the rescued flavanols with cholesterol-lowering plant sterols to make chocolate bars and chocolate-covered almonds.  By 2002, the company decided that it had enough research to promote CocoaVia candies as heart-healthy.[v]  As the New York Times put it, Mars was on a “corporate quest to transform chocolate into a healthy indulgence.”[vi]  Mars marketed the candy bars—two a day, no less—as a means to increase blood flow, lower blood pressure, and reduce the risk for heart disease.

The FDA takes a dim view of unproven claims like “chocolate prevents heart disease.”  In 2006, the agency sent Mars a warning letter complaining that claims like “promotes a healthy heart” and “now you can have real chocolate pleasure with real heart health benefits,” were false, misleading, and easily misinterpreted…Chocolate, the FDA pointed out, is high in saturated fat (it didn’t mention sugar).   Furthermore, the claim “Cocoa Via Chocolate Bars contain natural plant extracts that have been proven to reduce bad cholesterol (LDL) by up to 8%,” meant that Mars was advertising chocolate as a drug.  If Mars wanted to make drug claims, it would need to conduct clinical trials to prove that eating CocoaVia chocolate bars prevented heart disease.[vii]

Rather than run the financial and scientific risk of doing that, Mars gave up on candy bars and began marketing CocoaVia in pills and powder as a “daily cocoa extract supplement.”  In doing this, Mars could take advantage of the more lenient marketing claims allowed by the Dietary Supplement Health and Education Act (DSHEA) of 1994. This act permits “structure/function” claims, those proposing that a supplement is good for some structure or function of the body.  Under DSHEA, the labels of CocoaVia are allowed to say that these supplements “promote a healthy heart by supporting healthy blood flow.”

To convince people to take CocoaVia supplements, Mars funds research.  In 2015, it funded studies demonstrating that cocoa flavanols are well tolerated in healthy men and women,[viii] support healthy cognitive function in aging,[ix] can reverse cardiovascular risk in the healthy elderly,[x] and improve biomarkers of cardiovascular risk.[xi]

Lest the “eat more chocolate” implications of these studies be missed, Mars issued a press release: “Cocoa flavanols lower blood pressure and increase blood vessel function in healthy people.”[xii]  The company followed this announcement with a full-page ad in the New York Times quoting a dietitian: flavanols “support healthy blood flow…which allows oxygen and nutrients to get to your heart more easily.”  …The ad directed readers to more information on a paid ad on the Times’ Website.  You have to look hard in these ads to discover that Mars owns CocoaVia; the company’s name only appears in barely legible print as part of the trademark.[xiii]

But Mars, which already has funded “more than 150 peer-reviewed scientific papers and [has] approximately 100 patents globally in the field of cocoa flavanols”[xiv] has more ambitious research plans.  In 2014, the company announced that in partnership with the National Heart, Lung, and Blood Institute it would provide “financial infrastructure support “ for an ambitious placebo-controlled, randomized trial of the effects of cocoa flavanols alone or in combination with vitamin supplements, on heart disease and cancer risk in 18,000 men and women over the age of 60.[xv]  The five-year trial, called the Cocoa Supplement and Multivitamin Outcomes Study (COSMOS), has evolved somewhat since then.  It now lists Brigham and Women’s Hospital in Boston as the sponsor, and Mars as a “collaborator” along with the Fred Hutchinson Cancer Research Center in Seattle and Pfizer. NIH seems no longer to be involved.[xvi]

We now have the result of this trial.  Even though cocoa flavanol supplements did not reduce cardiovascular events, Mars got its money’s worth from what must have been a very expensive study.

Tomorrow: a second report from this trial, with surprising results.

References

[i] Mars, Inc.  The history of CocoaVia.  CocoaVia.com

https://www.cocoavia.com/how-we-make-it/history-of-cocoavia

[ii] Vlachojannis J, Erne P, Zimmermann B, Chrubasik-Hausmann S.  The impact of cocoa flavanols on cardiovascular health.  Phytother Res.  2016;30(10):1641-57.

[iii] Andres-LaCueva C, Monagas M, Khan N, et al.  Flavanol and flavonol contents of cocoa powder products: influence of the manufacturing process.  J Agric Food Chem. 2008;56:3111-17.

[iv] Crews WD, Harrison DW, Wright JW.  A double-blind, placebo-controlled, randomized trial of the effects of dark chocolate and cocoa on variables associated with neuropsychological functioning and cardiovascular health: clinical findings from a sample of healthy, cognitively intact older adults.  Am J Clin Nutr. 2008;87(4):872-80.

[v] Meek J.  Chocolate is good for you (or how Mars tried to sell us this as health food).  The Guardian, Dec 23, 2002.

https://www.theguardian.com/uk/2002/dec/23/research.highereducation

[vi] Barrionuevo A.  An apple a day for health?  Mars recommends two bars of chocolate.  NY Times, Oct 31, 2005.

The FDA considers candy bars to be foods labeled with Nutrition Facts panels.  Supplements are labeled with Supplement Fact panels.

[vii] FDA.  Inspections, compliance, enforcement, and criminal investigations.  Warning letter to Mr. John Helferich, Masterfoods USA.  FDA, May 31, 2006.  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/ucm075927.htm

[viii] Ottaviani JI, Balz M, Kimball J, et al. Safety and efficacy of cocoa flavanol intake in healthy adults: a randomized, controlled, double-masked trial.  Am J Clin Nutr. 2015;102(6):1425-35.

[ix] Necozione S, Raffaele A, Pistacchio L, et al.  Cocoa flavanol consumption improves cognitive function, blood pressure control, and metabolic profile in elderly subjects: the Cocoa, Cognition, and Aging (CoCoA) Study—a randomized controlled trial  Am J Clin Nutr. 2015; 101:538-48.

[x] Heiss C, Sansone R, Karimi H, et al.  Impact of cocoa flavanol intake on age-dependent vascular stiffness in healthy men: a randomized, controlled, double-masked trial.  Age. 2015;37:56.

[xi] Sansone R, Rodriguez-Mateos A, Heuel J, et al.  Cocoa flavanol intake improves endothelial function and Framingham Risk Score in healthy men and women: a randomised, controlled, double-masked trial: the Flaviola Health Study.  Brit J Nutr. 2015;114(8):1246-55.

[xii] Mars Center for Cocoa Health Science.  Press release: Cocoa flavanols lower blood pressure and increase blood vessel function in healthy people.  MarsCocoaScience.com, Sep 9, 2015.  http://www.marscocoascience.com/news/cocoa-flavanols-lower-blood-pressure-and-increase-blood-vessel-function-in-healthy-people.

[xiii] CocoaVia.  Cocoa’s past and present: a new era for heart health.  NY Times, Sep 27, 2015.  http://paidpost.nytimes.com/cocoavia/cocoas-past-and-present-a-new-era-for-heart-health.html?_r=0

[xiv] Mars Symbioscience.  Explore Mars Symbioscience.  Mars.com.

http://www.mars.com/global/brands/symbioscience

[xv] Mars.  Largest nutritional intervention trial of cocoa flavanols and hearth (sic) health to be launched.  MarsCocoaScience.com, Mar 17, 2014.

http://www.marscocoascience.com/news/largest-nutritional-intervention-trial

[xvi] The trial is registered at COcoa Supplement and Multivitamin Outcomes Study (COSMOS).    ClinicalTrials.gov.

https://clinicaltrials.gov/ct2/show/NCT02422745

[xvii] ASRC (Advertising Self-Regulatory Council).  NAD recommends Mars modify certain claims for CocoaVia cocoa extract.  ASRCReviews.org, Aug 11, 2016.

http://www.asrcreviews.org/nad-recommends-mars-modify-certain-claims-for-cocoavia-cocoa-extract/

Two studies of the role of nuts in health.

I.  This one comes from ObesityandEnergetics.org’s “Headline vs. Study.”

Headline: Maximum Wellness: Walnuts are a Life-Extension Food:  “Looks like your [sic] nuts not to include walnuts in your diet. For more information and to read this study…go to maxwellnutrition.com, where you can find top wellness and nutrition products made in the United States – shipped to your door.”  [Comment: Clearly, we are dealing here with marketing]

Study: Association of Self-Reported Walnut Consumption with Total and Cause-Specific Mortality and Life Expectancy in U.S. Adults. Maximum Wellness nor Causation Necessarily Established.  Liu, X.; Guasch-Ferré, M.; Tobias, D.K.; Li, Y.  Nutrients 2021, 13, 2699. https://doi.org/ 10.3390/nu13082699

Conclusion: A greater life expectancy at age 60 (1.30 years in women and 1.26 years in men) was observed among those who consumed walnuts more than 5 servings/week compared to non-consumers.  Higher walnut consumption was associated with a lower risk of total and CVD mortality and a greater gained life expectancy among U.S. elder adults.  [Comment: association, not causation, and the difference is small].

Conflict of interest: The last (senior?) author reports having received research support from California Walnut Commission, but states that ” The funder has no role in the design and conduct of the study, in the collection, analysis, and interpretation of the data, and in the preparation, review, or in the decision to publish the results.”  [Comment: That’s what they all say, but research often demonstrates otherwise, as I review in my book Unsavory Truth].

And now for the second:

II.  Association of nut consumption with risk of total cancer and 5 specific cancers: evidence from 3 large prospective cohort studies.  Zhe Fang, You Wu, Yanping Li, Xuehong Zhang, Walter C Willett, A Heather Eliassen,1Bernard Rosner,
Mingyang Song, Lorelei A Mucci,and Edward L Giovannucci.  The American Journal of Clinical Nutrition, Volume 114, Issue 6, December 2021, Pages 1925–1935, https://doi.org/10.1093/ajcn/nqab295

Conclusion: In 3 large prospective cohorts, frequent nut consumption was not associated with risk of total cancer and common individual cancers.  [Comment: What? An industry-funded study that finds no benefuts?]

Funding: Supported by the California Walnut Commission and Swiss Re Management Ltd (to YL),… and NIH grants U01 CA167552 (to LAM and the Health Professionals Follow-up Study), UM1 CA186107 and P01 CA87969 (to the Nurses’ Health Study), and U01 CA176726 (to AHE and the Nurses’ Health Study II). The funding sources did not participate in the study design; or
collection, analysis, or interpretation of the data; or preparation, review, or approval of the manuscript.

Here’s how the authors explain their highly unusual no-benefit result:

Given the scarcity of available high-quality data, our findings add to current evidence to more precisely determine the relation between nut consumption and cancer risk. So far, the population based evidence has not been strong enough to conclude that nut consumption is protective against total cancer and these 5 common cancers. Future studies on other cancer sites are still needed to examine the benefits of nuts on cancer development.

Really?  Why?  Do the authors not believe their own data?  Their findings ought to settle the matter and encourage the authors to move on to more significant research.  “More research needed” keeps the California Walnut Commission busy.

Research funded by food companies always requires a degree of skepticism, no matter what the results.

I’m kind of a dairy agnostic.  If you like dairy foods, fine; if not, don’t eat them.

But the arguments about them are fierce, and the current Dietary Guidelines for Americans advise choosing low-fat alternatives.

So when I saw the title of this study, I wondered whether it had been funded by the dairy industry.  It was not, although some of the investigators have dairy industry ties.

The study: Whole-fat dairy products do not adversely affect adiposity or cardiometabolic risk factors in children in the Milky Way Study: a double-blind randomized controlled pilot study.  Analise Nicholl, Kane E Deering, Kate Evelegh, Philippa Lyons-Wall, David Lawrence, Trevor A Mori, Mario Kratz, Therese A O’Sullivan.  The American Journal of Clinical Nutrition, Volume 114, Issue 6, December 2021, Pages 2025–2042, https://doi.org/10.1093/ajcn/nqab288

Conclusions: Our results suggest that although changing from whole-fat to reduced-fat dairy products does reduce dairy fat intake, it does not result in changes to markers of adiposity or cardiometabolic disease risk in healthy children.

Acknowledgments: …The Principal Investigator, TAOS, was awarded funding in 2011 for a previous study from the Dairy Health and Nutrition Consortium. MK has received honoraria and reimbursements for travel as well as a research grant from several dairy-related organizations, including National Dairy Council/Dairy Management Inc., Dairy Farmers of Canada, the Dutch Dairy Association (Nederlandse Zuivel Organisatie), Dairy Australia, and the French Interbranch Organization (CNIEL). All other authors report no conflicts of interest.

Notes: …No funding body played any role in the Milky Way Study design, implementation, analysis or interpretation of the data, or publication. The Milky Way Study received no funding from any dairy or food industry organization or affiliation toward study research, dairy product purchase or provision, child assessments, project personnel, or publication.

Comment: No funding body needed to be involved in this study to raise questions of conflicted interests; two of the authors report financial ties to dairy companies.  At the very least, these ties give the appearance of conflict of interest.  Are dairy foods good, bad, or indifferent for health?  My guess is that like pretty much everything else in the diet, it depends on everything else you are eating (unless you are lactose or dairy protein intolerant, in which case you know to avoid dairy foods).  The underlying purpose of this study is to encourage sales of full-fat dairy products to children.   Is that a good idea?  You decide.

Reference: For a summary of research on the “funding effect”—the observation that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests, but that recipients of industry funding typically do not recognize its influence—see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

The study: Impact of low-fat and full-fat dairy foods on fasting lipid profile and blood pressure: exploratory endpoints of a randomized controlled trial.  Kelsey A Schmidt, et al. The American Journal of Clinical Nutrition, nqab131, https://doi.org/10.1093/ajcn/nqab131.  Published: 13 July 2021

Background: “Dietary guidelines traditionally recommend low-fat dairy because dairy’s high saturated fat content is thought to promote cardiovascular disease (CVD). However, emerging evidence indicates that dairy fat may not negatively impact CVD risk factors when consumed in foods with a complex matrix.”

Method: “Participants were then randomly assigned to 1 of 3 diets, either continuing the limited-dairy diet or switching to a diet containing 3.3 servings/d of either low-fat or full-fat milk, yogurt, and cheese for 12 wk.”

Conclusions: “In men and women with metabolic syndrome, a diet rich in full-fat dairy had no effects on fasting lipid profile or blood pressure compared with diets limited in dairy or rich in low-fat dairy. Therefore, dairy fat, when consumed as part of complex whole foods, does not adversely impact these classic CVD risk factors.”

Funding: “National Dairy Council, Dairy Farmers of Canada, Dutch Dairy Association (Nederlandse Zuivel Organisatie), Dairy Australia, and the French Dairy Interbranch Organization (CNIEL),” and NIH and others.

Conflict of interest: “This study was initiated by the principal investigator (MK). The dairy-related funding organizations suggested changes to details of the study design prior to the conduct of the study, some of which were implemented. Otherwise, the funding organizations had no impact on the design or conduct of the trial or the analysis and interpretation of study data.”

Comment: Let’s give these investigators high marks for disclosing that the dairy funders influenced the design of the study, which, as we know from the data of Lisa Bero and her colleagues, is the place where biases caused by industry funding most typically show up.  Food companies that fund research are looking for benefits; they won’t risk study designs that might yield inconvenient results.

Reference: For a summary of research on the “funding effect”—the observations that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests and that recipients of industry funding typically did not intend to be influenced and do not recognize the influence—see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

Stanford University issued a press release to announce the results of a study comparing physiological effects of eating plant-based meat alternatives (Beyond Meat) to eating foods of animal origin.

A diet that includes an average of two servings of plant-based meat alternatives lowers some cardiovascular risk factors compared with a diet that instead includes the same amount of animal meat, Stanford Medicine scientists found.

The study:  A randomized crossover trial on the effect of plant-based compared with animal-based meat on trimethylamine-N-oxide and cardiovascular disease risk factors in generally healthy adults: Study With Appetizing Plantfood—Meat Eating Alternative Trial (SWAP-MEAT).  Crimarco A, et al.  American Journal of Clinical Nutrition, August 11, 2020.  https://doi.org/10.1093/ajcn/nqaa203

Overall conclusion: “This study found several beneficial effects and no adverse effects from the consumption of plant-based meats.”

The sponsor: “Supported by a research gift from Beyond Meat Inc. (to CDG)…Funding for this study was provided by Beyond Meat. In an effort to reduce any influences on the outcomes of this study, a statistical analysis plan was submitted to ct.gov. The main analysis was conducted by a third-party individual who had no involvement with the study design or collection of data, and was blinded to all study participants.

Comment

Ordinarily, I would simply present this study as a classic example of how industry-funded studies predictably produce results that favor the commercial interests of their sponsors, a topic to which I devoted my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

But CDG is Christopher Gardner, the study’s lead scientist, whose impressive track record of managing complicated clinical trials of diet and health I greatly admire.

Gardner describes himself as a vegan (meaning that he eats no animal products).

Knowing of my concerns about industry-funded research, he wrote me some months ago to say that this study was in the works and to point out that he has done at least six industry-funded studies with null findings (he sent me a PowerPoint slide deck to prove it).  In his correspondence, he said:

• “I believe this is the FIRST industry funded study I’ve run that had a significant positive health finding.”
• “Beyond Meat was not involved in design or analysis, and to this day still doesn’t know the study outcome.”
• “I’m preparing myself for being called out as a vegan industry shill….hoping I’ve established a reputation for objectivity to withstand this ?”
• “PS – Hope you enjoy the study acronym (Study With Alternative Plantfood – Meat Eating Alternative Trial: SWAP-MEAT)” [Indeed I do].

OK.  So let’s take this study on its merits.

Gardner asked healthy non-vegetarian adults (36) to consume 2 servings a day of either Beyond Meat or regular meat (what the study calls Animal Meat).  The Beyond Meat and Animal Meat were provided to participants.  The rest of their diets was on their own.

For 8 weeks, they ate Beyond Meat or Animal Meat.  For the next 8 weeks, they switched over to the other kind.

Results: Participants consuming Beyond Meat displayed lower levels of

• LDL-cholesterol (the bad kind)
• Body weight (by 1 or 2 pounds)
• TMAO (Trimethylamine N-oxide)—but only for those who consumed Animal Meat first and Beyond Meat second (not the other way around)

Beyond Meat may be plant-based, but it is ultraprocessed.  FoodNavigator produced a nice comparison.

Beyond Meat would dearly love to demonstrate that its ultraprocessed composition is immaterial to its health benefits.  Hence: this study.

Beyond Meat is already using it for marketing purposes: “New study finds health benefits of plant-based meats.”

As I see it, there are two issues here: (a) what else the participants were eating and (b) the significance of the TMAO measurements.

(a) The diet: This was not a controlled dietary intake trial conducted in a closed metabolic ward.  Participants were free to eat whatever they liked and how much they liked.  They lost a little weight during the Beyond Meat phase, which means they must have been eating fewer calories during that phase, as they reported (this graph is in the Supplementary material).

Reported daily calories were under 2000, which means that lots of calories must not have been reported.  So it’s hard to know what the weight loss is actually due to.

(b)  TMAO: You make TMAO after you eat foods containing choline, a compound common in animal-based foods: meat, poultry, fish, and eggs.  A 2019 editorial review in JAMA discusses the association of TMAO with heart disease risk.

Now, researchers are homing in on another possible culprit: a dietary metabolite linked to red meat called trimethylamine N-oxide, or TMAO. Three recent meta-analyses confirmed that high blood levels of TMAO are associated with increased risks of cardiovascular disease and all-cause mortality. One of the studies, published in the Journal of the American Heart Association in 2017, found a more than 60% heightened risk of both major adverse cardiovascular events and death from all causes in people with elevated TMAO. Other research has associated higher TMAO levels with heart failure and chronic kidney disease.

On the other hand, an analysis by Dr. Bret Scher raises questions about whether TMAO has any real meaning for health (and I thank Stephen Zwick for sending this to me).

In my opinion, this is an example of a well-run study that, in the end, lends very little to our knowledge of human health….The main outcome from this intervention had to do with TMAO. Why is this problematic? Well, it has to do with the fact that small, short-term trials are unable to measure meaningful endpoints, such as who lives, dies, or who gets heart disease.  So, instead, the authors have to choose the surrogate outcome markers that they believe relate to human health.

Dr. Scher believes that “There is no convincing evidence that these results impact someone’s health.”  As Scher has discussed previously, he sees no cause-and-effect relationship between TMAO levels and health.  You can read his arguments here:

• Eating red meat increases TMAO levels. Should we care?
• TMAO — Smoking gun or passive observer?

The bottom line?  This study suggests that two servings a day of Beyond Meat is unlikely to be harmful.  Whether substituting Beyond Meat for real meat is truly useful for health in the absence of other dietary changes remains to be confirmed, hopefully by independently funded research.

The American Journal of Clinical Nutrition has a new study with a startling conclusion: “frequent consumption of fried potatoes appears to be associated with an increased mortality risk” (here’s a news report about it).

For lovers of French fries, this is unhappy news.  Or is it?

The study looked at potato intake (fried and unfried) reported by 4440 participants aged 45–79 y at baseline for 8 years, as part of a study on osteoarthritis.  Participants with the highest consumption of potatoes had the same mortality as those consuming the lowest amount.

But when they looked at the subgroup consuming fried potatoes 2–3 times per week, the risk of mortality doubled.

It’s not potatoes that might be a problem; it’s just those that are fried.  Even so,

• The study is based on intake reported in food frequency questionnaires
• The results are not cleanly dose-related; mortality rates were higher among people reporting fried potatoes twice a week than those reporting more
• People who eat lots of fried potatoes are likely to indulge in other unhealthful dietary or lifestyle practices.

But this is not the first study to report health problems among frequent eaters of fried potatoes.  See:

• Potato consumption and risk of cardiovascular disease: 2 prospective cohort studies
• Fried-food consumption and risk of type 2 diabetes and coronary artery disease: a prospective study in 2 cohorts of US women and men
• Maternal intake of fried foods and risk of gestational diabetes mellitus.
• Potato Consumption and Risk of Type 2 Diabetes
• Adolescent Energy Drink Use Related to Intake of Fried and High-sugar Foods

This is a lot to blame on one food.  I vote for lifestyle confounding.

Put French fries in your once-in-awhile category.  I’m saving my allotment for the Belgian ones.

I’m having a hard time keeping up with these, but here are five more industry-funded studies with results favorable to the sponsor, bringing the total of industry-positives to 124 since last March, versus just 12 with unfavorable results.  This percentage is lower than that found in more systematic studies.  If you know of such studies, please send.

In the meantime, here’s the next set.

A randomized controlled trial to determine the efficacy of a high carbohydrate and high protein ready-to-eat food product for weight loss.  N. R. Fuller, M. Fong, J. Gerofi, L. Leung, C. Leung, G. Denyer andI. D. Caterson.  Clinical Obesity. Article first published online: 19 JAN 2016. DOI: 10.1111/cob.12137

• Conclusion: There was no significant difference in percentage weight loss from screening to 6 weeks between the two groups…Both diets were nutritionally matched and well-accepted over the 6-week period. This study shows that the inclusion of a ready-to-eat food product can be included as part of a dietary programme to achieve a clinically significant weight loss over a short period.
• Funding: This study was supported by a research grant from Arnotts Biscuits Ltd. The funder had no role in the protocol design, the conduct of the study, the analysis of the data, nor the writing of the manuscript.
• Comment: The idea of this study was to get participants to include Vita-Weat biscuits in their diets.  The control group was simply advised about healthy eating.  Both groups lost weight.  Arnotts Biscuits makes Vita-Weat.

Obesity, Fitness, Hypertension, and Prognosis: Is Physical Activity the Common Denominator?  Carl J. Lavie, MD, Parham Parto, MD; Edward Archer, PhD. JAMA Intern Med. 2016;176(2):217-218. doi:10.1001/jamainternmed.2015.7571.

• Conclusions: Although excess caloric load has been suggested as a major contributor to obesity, we believe that marked declines during the past 5 decades in leisure time and occupational physical activity explain the notable increase in BMI over time… Therefore, substantial efforts are needed, beginning in children and adolescents and extending into adulthood, to increase levels of physical activity across all ages and in both sexes, which would have substantial effects on preventing obesity and improving levels of CRF [cardiorespiriatory fitness].
• Conflict of Interest Disclosures: Dr Lavie reported being the author of the book The Obesity Paradox and serving as a lecturer for the Coca Cola Company (on physical activity, exercise, fitness, and the obesity paradox and not on their products). Dr Archer reported received speaking fees from industry and nonprofit organizations.
• Comment: Coca-Cola has been especially active in funding investigators who promote the idea that physical activity is more important that diet in determining health status.  This paper is a commentary on a study demonstrating that “high BMI and low aerobic capacity in late adolescence were associated with higher risk of hypertension in adulthood…interventions to prevent hypertension should begin early in life and include not only weight control but aerobic fitness, even among persons with normal BMI.”

Dietary anthocyanin intake and age-related decline in lung function: longitudinal findings from the VA Normative Aging Study.  Amar J Mehta,, Aedín Cassidy, Augusto A Litonjua, David Sparrow, Pantel Vokonas, and Joel Schwartz.  Am J Clin Nutr February 2016 vol. 103 no. 2 542-550

• Conclusions: An attenuation of age-related lung function decline was associated with higher dietary anthocyanin intake in this longitudinal sample of predominantly elderly men. Further prospective studies are needed to confirm these novel associations.
• Conflicts: AC has a grant, unrelated to this project, to conduct observational and experimental studies of blueberries and cardiovascular health outcomes from the US Highbush Blueberry Council. None of the other authors had competing interests to declare.
• Comment:  This paper is about blueberry anthocyanins.  The authors report “Blueberry intake was associated with the slowest rate of annual decline in lung function; compared with no or very low intake.”

The effects of lutein on cardiometabolic health across the life course: a systematic review and meta-analysis.  Elisabeth TM Leermakers, Sirwan KL Darweesh, Cristina P Baena, Eduardo M Moreira, Debora Melo van Lent, Myrte J Tielemans, Taulant Muka, Anna Vitezova, Rajiv Chowdhury, Wichor M Bramer, Jessica C Kiefte-de Jong, Janine F Felix, and Oscar H Franco.  Am J Clin Nutr February 2016 vol. 103 no. 2 481-494

• Conclusions: Our findings suggest that higher dietary intake and higher blood concentrations of lutein are generally associated with better cardiometabolic health. However, evidence mainly comes from observational studies in adults, whereas large-scale intervention studies and studies of lutein during pregnancy and childhood are scarce.
• Funding: ETML, DMvL, MJT, JCK-dJ, and OHF are employees at ErasmusAGE, a center for aging research across the life course funded by Nestlé Nutrition (Nestec Ltd.), Metagenics Inc., and AXA. Nestlé Nutrition (Nestec Ltd.), Metagenics Inc., and AXA had no role in the design or conduct of the study; the collection, management, analysis, or interpretation of the data; or the preparation, review, or approval of the manuscript. None of the authors reported a conflict of interest related to the study.

Dietary protein intake is associated with body mass index and weight up to 5 y of age in a prospective cohort of twins.  Laura Pimpin, Susan Jebb, Laura Johnson, Jane Wardle, and Gina L Ambrosini.  First published December 30, 2015, doi: 10.3945/​ajcn.115.118612.  Am J Clin Nutr February 2016 vol. 103 no. 2 389-397

• Conclusion: A higher proportion of energy from protein during the complementary feeding stage is associated with greater increases in weight and BMI in early childhood in this large cohort of United Kingdom children.
• Conflicts: JW: was principal investigator of the Gemini study with responsibility for data collection; and all authors: advised on the analyses or interpretation of data and contributed to manuscript preparation. JW received grants from Cancer Research UK and from Danone Baby Nutrition during the conduct of the study. LJ received institutional consultancy fees from Danone Baby Nutrition during the conduct of the study. All other authors declared no conflicts of interest.