by Marion Nestle

Search results: PURE study

Sep 5 2017

The PURE study warrants some skepticism

I love getting notes like this one from a reader:

Why aren’t you saying anything about the PURE study.  Doesn’t it prove that everything you’ve been saying about eating more fruits and vegetables and about saturated fat is wrong, wrong, wrong.  Admit it.

Not this time.  Whenever I hear the claim that “everything you thought about nutrition is wrong,” I know that skepticism is in order.  Science rarely works that way; it usually progresses incrementally.

What the PURE study is about: The PURE (Prospective Urban Rural Epidemiology) study was designed to examine, among other things, the effects of lifestyle behaviors on the health of about 135,000 people in 18 countries over up to 10 years.  Its results have just been published in Lancet journals.

What the headlines say: “Study challenges conventional wisdom on fats, fruits and vegetables.”

What the studies say:  Three papers report results: 

1,  Fruit, vegetable, and legumes vs. cardiovascular disease and death

Higher fruit, vegetable, and legume consumption was associated with a lower risk of non-cardiovascular, and total mortality. Benefits appear to be maximum for both non-cardiovascular mortality and total mortality at three to four servings per day (equivalent to 375–500 g/day).

2.  Fat and carbohydrate vs. cardiovascular disease and death

High carbohydrate intake was associated with higher risk of total mortality, whereas total fat and individual types of fat were related to lower total mortality. Total fat and types of fat were not associated with cardiovascular disease, myocardial infarction, or cardiovascular disease mortality, whereas saturated fat had an inverse association with stroke. Global dietary guidelines should be reconsidered in light of these findings.  [Note: the data do not distinguish types of carbohydrate.]

3.  Association of nutrients with blood lipids and blood pressure

Our data are at odds with current recommendations to reduce total fat and saturated fats. Reducing saturated fatty acid intake and replacing it with carbohydrate has an adverse effect on blood lipids. Substituting saturated fatty acids with unsaturated fats might improve some risk markers, but might worsen others.

Why the need for skepticism:

I like the way James Hamblin explains the problem in The Atlantic:

The practically important findings were that the healthiest people in the world had diets that are full of fruits, beans, seeds, vegetables, and whole grains, and low in refined carbohydrates and sugar.

As a writer and a reader, though, this is very boring. If I pitched that to my editor, he would laugh at me. What is new here? Why is this interesting? You know what would be novel? You getting fired! Now get out there and find me a story, dammit!

Why did they do this study?  

I looked immediately to see who paid for it.  The list of funders is very long (it must have been extremely expensive).  The list begins:

The PURE Study is an investigator initiated study funded by the Population Health Research Institute, the Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Ontario, support from CIHR’s Strategy for Patient Oriented Research (SPOR) through the Ontario SPOR Support Unit, as well as the Ontario Ministry of Health and Long­Term Care and through unrestricted grants from several pharmaceutical companies, with major contributions from AstraZeneca (Canada), Sanofi­Aventis (France and Canada), Boehringer Ingelheim (Germany and Canada), Servier, and GlaxoSmithkline, and additional contributions from Novartis and King Pharma and from various national or local organisations in participating countries [the funders that follow are mainly government and private research bodies along with a sugar trade association and more drug companies—the list takes up more than half a column].

Drug companies have a big interest in this topic, especially if dietary approaches to heart disease prevention aren’t proven.

What the PURE study really tells us: For this, I am going to quote from David Katz’s lengthy analysis:

On the basis of all of the details in these published papers, the conclusion, and attendant headlines, might have been: “very poor people with barely anything to eat get sick and die more often than affluent people with access to both ample diets, and hospitals.” One certainly understands why the media did NOT choose that! It is, however, true- and entirely consistent with the data.

Also, by way of reminder: the HIGHEST levels of both total fat, and saturated fat intake observed in the PURE data were still LOWER then prevailing levels in the U.S. and much of Europe, providing no basis whatsoever for headlines encouraging people already exceeding these levels to add yet more meat, butter, and cheese to their diets. Absolutely none.

My translation: This study confirms that the single most important risk factor for poor health is poverty.  The study results are consistent with the idea that largely plant-based diets are good for health.  No single study can settle the fat vs. carbohydrate debate because people eat complicated combinations of foods and diets containing those nutrients.  What we really need are well designed studies of dietary patterns—the ones done to date suggest that largely plant-based diets are associated with excellent health and longevity.  

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Feb 12 2024

Industry-funded study of the week: Et tu saffron?

I learned about this one from NutraIngredients-Europe:

The ‘promising’ role of saffron in stress resilience:  New research conducted in partnership with botanical product manufacturer Pharmactive reveals that its standardized saffron extract Affron was able to normalise HPA [hypothalamic-pituitary-adrenal] axis dysregulation following chronic mild stress stimulation in a rat model…. Read more

I thought this was worth a closer look and went right to the paper.

Effects of Saffron Extract (Affron®) with 100 mg/kg and 200 mg/kg on Hypothalamic–Pituitary–Adrenal Axis and Stress Resilience in Chronic Mild Stress-Induced Depression in Wistar Rats. Nutrients 2023, 15(23), 4855; https://doi.org/10.3390/nu15234855

Conclusion: These findings elucidate AFN’s [Affron®] role in stress mitigation, affirm its health benefits, validate its potential as a treatment for stress-related symptoms, confirm its physiological effectiveness, and emphasize its therapeutic promise.

Guess who generated and conducted this study.

Conflict of interest statement: For commercial affiliations, J.K. and S.Y. were employed by the company iCONNECTOME Co., Ltd., which had the roles of curation, formal analysis, and visualization in this study; S.-S.Y. was employed by the company iCONNECTOME Co.,Ltd., which had the roles of conceptualization, funding acquisition, investigation, supervision, review and editing in this study; M.-Y.K. and J.S. were employed by the company Hyundai Bioland Co.,Ltd., which had the roles of methodology and/or writing original draft in this study; M.I.M.-V. was employed by the company Pharmactive Biotech S.L.U., which had the role of investigation in this study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

In case you wondered, Pharmactive Biotech makes Affron.  The other enterprises do the studies.

Who paid for this?

Funding: This research was funded by Hyundai Bioland Co., Ltd., grant number IC22_02, and Soonchunhyang University Research Fund. Hyundai Bioland Co., Ltd. had the following involvement with the study: participating in the research Investigation, and paid all costs for editing and publishing the Paper. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication.

Comment: Huh?  I often suspect that the statement “the funder was not involved….” may not accurately represent the funder’s involvement (to put the matter politely).  In this case,  the role of Hyundai Bioland is self-contradictory.  Its employee-authors say they determined the study’s methods and/or wrote the paper, and the funder says it participated in the research but had no involvement in the study design, etc.  This is confusing, if not contradictory.

I do have to say something about marketing saffron as a superfood.  Saffron consists of the stigmas of crocus flowers, and these are hugely expensive.  Walmart is selling 2 grams for $42.

The Wikipedia entry iexplains why.

The high retail value of saffron is maintained on world markets because of labour-intensive harvesting methods, which require some 440,000 hand-picked saffron stigmas per kilogram…150,000 crocus flowers per kilogram…Forty hours of labour are needed to pick 150,000 flowers…One freshly picked crocus flower yields on average 30 mg of fresh saffron or 7 mg dried; roughly 150 flowers yield 1 g (1⁄32 oz) of dry saffron threads.

Once again, we have here an industry-funded marketing study pretending to be science.  But really, saffron?   OK, an extract that maybe can be synthesized, but still.  There have to be easier and less expensive ways to reduce stress and depression in rats.

Oh.  And in case you were wondering how scientists determine whether rats are depressed?

Our previous animal behavioral assays assessing anxiety and depression, including the elevated plus maze, forced swim, and sucrose preference tests, have revealed that AFN-treated animals (200 mg/kg) exhibit behaviors indicative of anhedonia and depression mitigation [27]. For example, increased consumption of sugar solutions and improved specific escape responses have been observed in forced swim tests.

Ref 27 is: Orio, L.; Alen, F.; Ballesta, A.; Martin, R.; Gomez de Heras, R. Antianhedonic and Antidepressant Effects of Affron®, a Standardized Saffron (Crocus sativus L.) Extract. Molecules 2020, 25, 3207. [Google Scholar]

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Nov 14 2022

Industry-funded study of this week: Maple water!

Hat tip to Matthew Kadey for this one.  It’s a great example of a study title that makes me want to know : Who paid for this?

  • The study: Randy L. Aldret, Michael McDermott, Stephanie Aldret, Greggory Davis and David Bellar. The Acute Effects of a Maple Water Drink on Exercise Responses, Oxidative Stress and Inflammation in Overweight College Males. Journal of Food and Nutrition Research. 2022; 10(9):593-599. doi: 10.12691/jfnr-10-9-2
  • Rationale: “The purpose of this study was to examine the acute effect of maple water on exercise responses and biomarkers of post-exercise inflammation and muscle damage in an overweight male college population.”
  • Method: “The treatments for the study consisted of 12 fluid ounces (355ml) of pure MW (Drink Simple Maple Water, Drink Maple LLC) or an identical volume of distilled water flavored with maple extract to mimic the smell and taste.”
  • Conclusion: “Early outcomes indicate maple water has positive benefits for those that exercise in the areas of cardiovascular fitness and post exercise inflammation.”
  • Competing Interests: “The authors declare the following real or perceived conflicts of interest in the context of this study: financial conflict of interest, as this study was funded in part by grants from Drink Simple LLC (Grant #370261).”
  • Comment:  The comparison here is maple water versus plain water.  Maple water contains sugars and electrolytes (potassium, manganese, calcium); the water placebo does not.  The result seems predictable from the funder, as is the study design.

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Mar 21 2022

Industry-funded study of the week: Cocoa flavanols

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/

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Mar 9 2020

Industry-funded study of the week: fruit extracts and cognitive function

I learned about this one from Nutra-Ingredients-latam.com, one of those industry newsletters I avidly follow: “Grapes plus blueberries may boost cognitive function in college students.”

The study: Acute Intake of a Grape and Blueberry Polyphenol-Rich Extract Ameliorates Cognitive Performance in Healthy Young Adults During a Sustained Cognitive Effort.  Philip P, et al.  Antioxidants 2019, 8, 650; doi:10.3390/antiox8120650.

Purpose: “This study investigated the acute and sustained action of a polyphenols-rich extract from grape and
blueberry (PEGB), on working memory and attention in healthy students during a prolonged and intensive cognitive effort.”

The comparison: “Participants were asked to either consume 600 mg of polyphenol-rich active extract made from
grape (Vitis vinifera L.) and wild blueberry (Vaccinium angustifolium) (Memophenol, Activ’Inside, Beychac et Caillau, France), or a placebo containing pure maltodextrin (Maltrin® M100, Roquette, Lestrem, France) and providing no polyphenol.”

Conclusion: “Our findings suggest that consumption of PEGB coupled with a healthy lifestyle may be a safe alternative to acutely improve working memory and attention during a sustained cognitive effort.”

Funding: This study was funded by Activ’Inside (Bordeaux area, France).

Comment: All I had to do was see the title of this study to guess that it was funded by a company with a vested interest in the study’s outcome.  Activ’Inside makes antioxidant extracts for purposes like this.  I’m all for college students eating grapes and blueberries rather than taking drugs to keep them up all night, but flavanol extracts?  Not the same.  Chalk this one up to marketing, not science.

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Dec 2 2015

Funded study with negative result: Are ruminant trans fats healthier than industrial trans fats? Alas, no. The score: 80:7

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).

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Jan 19 2010

Cascadian Purely O’s: betrayal or business as usual?

Thanks to my NYU Medical Center colleague, Dr. Melissa Bender for the alert about the blogosphere fuss over Cascadian Farm Purely O’s cereals.  Apparently, Cascadian Farm, now owned by Big Food General Mills:

quietly changed the recipe for its “Purely O’s” cereal — previously an unsweetened favorite among children/toddlers – to include three times the sugar, as well as new fillers/sweeteners such as corn meal and tapioca syrup. They did this with no announcement on the label, taking advantage of those who trusted the brand for its previous simplicity. Loyal customers, particularly parents who had chosen this product because it was one of the few unsweetened options available, are outraged by this secretive yet major reformulation. Many discovered the change when their children spat out the cereal (myself included).

Her note sent me right to the largest of the three Whole Foods stores within walking distance of my Manhattan apartment.  Purely O’s: 3 grams of sugars, 3 grams of fiber, and 160 mg sodium per serving.

Oops: low-sugar, yes, but only medium-fiber and high in sodium.  Even with 0 grams of sugar, it’s not all that great.  Neither, for that matter, is its non-organic analog Cheerios (1 gram sugar, 3 grams fiber, 190 mg sodium).

At 3 grams of sugar per serving, Purely O’s is still lower in sugar than practically every other cereal in Whole Foods.  Whole Foods does not sell Big Food non-organics, so it does not carry Cheerios.  I had to look hard to find the only cereal lower in sugar than the reformulated Purely O’s: Arrowhead Mills Shredded Wheat, Bite Size (2 grams of sugar, 6 grams of fiber, and only 5 mg sodium).  That one, it seems to me, is a much better choice to begin with, pretty much in the same category as oatmeal (1 gram of sugar, 4 of fiber, and 0 mg sodium).  When it comes to cereal, more fiber the better.  Fiber is the point of breakfast cereal.

So I can’t get too upset about the reformulation of Purely O’s.  It’s simply a business decision, entirely to be expected from Big Food.  Cascadian Farms started out with “humble beginnings” as a maker of organic products, none of them cereals.  It was successful enough to be bought first by Small Planet Foods, and later by General Mills, which wanted to get in on the organic market.  Hence: organic Purely O’s.

General Mills is in business to sell cereal, and Purely O’s just didn’t make it past focus groups, as reported in the Boston Globe earlier this year.  General Mills must think there are too few of its deeply loyal customers to matter.  According to a business school case study, it has a history along these lines.  So chalk this one up to corporate imperatives.

Dr. Bender wrote to General Mills and received a reply that said as much:

Our goal is to give consumers quality products at a good value. Prior to introducing any product, extensive consumer testing is done. We conduct market research and product testing continuously to obtain consumer reaction to existing products and to changes being considered. Only when we feel confident that a product change will broaden its appeal will we alter a product’s formulation. We are sorry that you do not agree that the recent change in Cascadian Farm organic Purely O’s cereal was for the better.

If the bloggers are looking for a replacement, try oatmeal or those cute little bite-sized shredded wheat things.

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Jan 30 2024

The endless hazards of commercial baby foods: lead and pesticides

LEAD

I’ve posted previously about the recent finding of high levels of lead—and now chromium—in applesauce pouches.

I’ve also posted about the inadequacy of inspections of such products.

The lead problems are continuing.

The FDA says it has received 89 complaints as of January 16, with the average age of the affected children less than one year (you have to scroll way down to see the latest updates).

The CDC says it has received reports from state and local health departments:

Total Cases: 385

Confirmed Cases: 97

Probable Cases: 253

Suspect Cases: 35

Both agencies say: Do not feed recalled products to your children!

  • WanaBana apple cinnamon fruit puree pouches – including three packs
  • Schnucks-brand cinnamon-flavored applesauce pouches and variety pack
  • Weis-brand cinnamon applesauce pouches

What caused this?  The best guess is (deliberate?) adulteration of the cinnamon.  Not nice to think about.

PESTICIDES

I read in The Guardian: Nearly 40% of conventional baby food contains toxic pesticides, US study finds.

The research, conducted by the Environmental Working Group (EWG) non-profit, looked at 73 products and found at least one pesticide in 22 of them. Many products showed more than one pesticide, and the substances present a dangerous health threat to babies, researchers said.

The EWG research: New EWG study (2023): Pesticides still found in baby food but most-toxic threats eliminated through advocacy, regulation.

  • New EWG research finds fewer pesticides in baby food than in the  groundbreaking 1995 study, Pesticides in Baby Food.
  • Though EWG detected some pesticides, the most toxic have been removed.
  • EWG’s advocacy helped drive market change – but the fight for safer food continues.
  • Federal oversight of pesticides in children’s food is inadequate, as explored in depth in a 1993 landmark National Academies of Science study.
  • No pesticides were detected in any of the 15 organic products.

Well, this message is clear: if you must buy commercial baby food, buy organic.

Overall, you are better off feeding babies the healthy foods you eat, pureed or cut up so they don’t cause choking, and as unsalted and unsugared as possible.

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