I’m always looking for food ideas for July 4th and thought this one looked just about perfect.  Have a happy and safe holiday!

I learned about this one as I often do from reading NutraIngredients’ daily newsletter:  RCT: Grape and blueberry extract improves cognitive health in ageing consumers.

This sounds great!  I went right to the article.

The study:  Effects of a polyphenol-rich grape and blueberry extract (Memophenol™) on cognitive function in older adults with mild cognitive impairment: A randomized, double-blind, placebo-controlled study   Adrian L. Lopresti, Stephen J. Smith, Camille Pouchieu Line Pourtau, David Gaudout, Véronique Pallet⁴ and Peter D. Drummond.  Front. Psychol., 29 March 2023.  Volume 14 – 2023 | https://doi.org/10.3389/fpsyg.2023.1144231

Background: Polyphenols are naturally occurring organic compounds found in plants. Research suggests that their intake reduces the risk of cognitive decline and related dementias. Grapes and blueberries are polyphenol-rich foods that have attracted attention for their potential cognitive-enhancing effects.

Purpose: Examine the effects of supplementation with a standardized and patented polyphenol-rich grape and blueberry extract (Memophenol™) on cognitive function in older adults with mild cognitive impairment.

Study design: Two-arm, 6 month, parallel-group, randomized, double-blind, placebo-controlled trial.

Methods: One hundred and forty-three volunteers aged 60 to 80 years with mild cognitive impairment were supplemented with either 150 mg of Memophenol™, twice daily or a placebo. Outcome measures included computer-based cognitive tasks, the Behavior Rating Inventory of Executive Function (BRIEF-A), the Cognitive Failures Questionnaire, and the CASP-19.

Results: Compared to the placebo, Memophenol™ supplementation was associated with greater improvements in the speed of information processing (p = 0.020), visuospatial learning (p = 0.012), and the BRIEF-A global score (p = 0.046). However, there were no other statistically significant between-group differences in the performance of other assessed cognitive tests or self-report questionnaires. Memophenol™ supplementation was well-tolerated with no reports of significant adverse reactions.

Conclusion: The promising results from this trial suggest that 6-months of supplementation with Memophenol™ may improve aspects of cognitive function in adults with mild cognitive impairment. Further research will be important to expand on the current findings and identify the potential mechanisms of action associated with the intake of this polyphenol-rich extract.

Funding: This study received funding from Activ’Inside. The funder was not involved in data collection, interpretation of data, or the decision to submit it for publication.

Conflict of interest: AL is the managing director of Clinical Research Australia, a contract research organization that has received research funding from nutraceutical companies. AL has also received presentation honoraria from nutraceutical companies. SS is an employee of Clinical Research Australia and declares no other conflicts of interest. PD and VP declare no conflicts of interest. DG, CP, and LP are employed at Activ’Inside and provided the Memophenol™ and placebo capsules.

Comment: Guess what Activ’Inside makes.  This study is not only funded by the maker of the supplement, but three of the authors work for the company.  This is contract research.  How can they say the funder was not involved?  The authors may not recognize it, but the funder was involved, and deeply.  How could it not be if the authors work for the company?

Earlier this week I wrote about the UNICEF-WHO meeting I went to in Geneva on implementing the 1981 International Code governing marketing of infant formulas.

UNICEF has just issued an update: What I [meaning you] Should Know about the Code

This new publication—a one-stop shopping guide to the issues—summarizes UN resolutions on the Code since 1981 as well as subsequent research on breastfeeding and infant formula marketing, most notably the Lancet Commission reports I wrote about earlier.

Incontrovertible evidence demonstrates how inappropriate marketing of infant formulas undermines breastfeeding and can harm children, especially in places that do not have clean water to dilute formulas.

Every country in the world has committed to the Code—the United States was the last holdout.  We do not seem to pay much attention to the Code’s provisions.

Here is one example.  The Code says:I’m not sure how to interpret the “except” phrase, except that our FDA must think that the health claims on a product like this are entirely acceptable, whereas they would not be allowed in many other countries.  [Reference 23 refers to UN General Assembly Resolution 63.23.]

The Code states that infant formulas should not be labeled in any way that suggests formula might be superior to breast milk.  This and the accompanying statement on the product website, would appear to violate that guideline.

Infant formulas do a good job of substituting for the nutrients in breast milk.  Because the FDA tightly regulates their ingredients, they are all pretty much alike, although they vary in price enormously.

The infant formula industry deserves close scrutiny of its marketing practices and this UNICEF publication is an excellent place to begin.

I have been asked to comment on the American Medical Association’s resolution to stop using the BMI as the sole criterion for diagnosing obesity [To find this resolution, click on CCSPH Report(s) #07: Support Removal of BMI as a Standard Measure in Medicine and Recognizing Culturally-Diverse and Varied Presentations of Eating Disorders].

The BMI—Body Mass Index—defined as weight in kilograms divided by height in meters squared—is a quick way to categorize the relationship of weight to height and does a better job of identifying people with excessive body fat than most other simple and inexpensive measures.

Unfortunately, not everyone demonstrates a close correlation of BMI to body fat and those who don’t may well find themselves discriminated against in the health care system.

The BMI is also an imperfect measure of health risk:

The current BMI classification system is also misleading regarding the effects of body fat mass on mortality rates. Numerous comorbidities, lifestyle issues, gender, ethnicities, medically significant familial-determined mortality effectors, duration of time one spends in certain BMI categories, and the expected accumulation of fat with aging are likely to significantly affect interpretation of BMI data, particularly in regard to morbidity and mortality rates…[This report] outlines the harms and benefits to using BMI and points out that BMI is inaccurate in measuring body fat in multiple groups because it does not account for the heterogeneity across race/ethnic groups, sexes, and age-span.

The resolution recommends:

(1) greater emphasis in physician educational programs on the risk differences among ethnic and age within and between demographic groups at varying
levels of adiposity, BMI, body composition, and waist circumference and the importance  of monitoring these waist circumference in all individuals with BMIs below 35 kg/m2;

(2) additional research on the efficacy of screening for overweight and obesity, using different indicators, in improving various clinical outcomes across populations, including morbidity, mortality, mental health, and prevention of further weight gain; and

(3) more research on the efficacy of screening and interventions by physicians to promote healthy lifestyle behaviors, including healthy diets and regular physical activity, in all of their patients to improve health and minimize disease risks.

My translation: Keep using the BMI as an indicator, but also pay attention to body composition and waist circumference as better measures of body fat.

The AMA is not minimizing the importance of excess body fat as a disease risk factor.  It is saying that only using the BMI to evaluate the risk itself risks stigmatizing patients, especially those of non-majority race, ethnicity, and gender conformation.

This resolution ought to further sensitize physicians to such issues.  If it does, it could not come a better time.

Resources

• Stat News on the resolution
• Ancel Keys et al’s original paper on the BMI: Indices of relative weight and obesity.

I am putting the Keys’ paper into this discussion to demonstrate that Keys was quite well aware of the strengths and weaknesses of the BMI, which was intended mainly to identify groups and populations at risk of undernutrition.

Guided by the criteria of correlation with height (lowest is best) and to measures of body fatness (highest is best), the ponderal index is the poorest of the relative weight indices studied.  The ratio of weight to height squared, here termed the body mass index, is slightly better in these respects than the simple ratio of weight to height. The body mass index seems preferable over other indices of relative weight on these grounds as well as on the simplicity of the calculation and, in contrast to percentage of average weight, the applicability to all populations at all times.

Once again I am indebted to Bill Marler for keeping me informed about items related to food safety: Publisher’s Platform: The House Appropriations Committee Directs the FDA to Restructure – will it be Ignored? 

He points to this item on page 79 of the House Agriculture Appropriations bill.

I’ve written about problems with the FDA’s oversight of food and food safety previously (see this for example).

Food has always been a stepchild at the FDA, getting much less attention than drugs or medical devices.  When I was on the FDA’s Food Advisory Committee in the early 1990s, the FDA seemed to be trying to do better but that committee did not last long.  In any case, we were not advising the FDA on what it was proposing to do; we were giving the FDA a notion of the response to decisions it had already made.

What’s needed now is to unite the three units of FDA that deal with food: the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine’s food oversight programs, and the office that overseed food regulations.

And bring back the Foods Advisory Committee and listen to its advice.

The FDA commissioned a report on what it should do (see Reagan-Udall Foundation report and my comments on it).

What will happen now?  As Bill Marler puts it, “Grab the popcorn.”

Here’s what the FDA says it’s doing (thanks to Jerry Hagstrom’s Hagstrom Report for the links)

• FDA — Proposed Human Foods Program Organization Chart 
• Updates to FDA Proposal to Unify Human Foods Program / Create New ORA Model
• Proposed Office of Regulatory Affairs Organization Chart

This does some of what’s needed but the organization charts still look complicated, and the more complicated an organization chart, the least likely it is to work.

Will this work?  Bill Marler says it might.  Grab the popcorn indeed.

Last week, I attended and spoke at the UNICEF-WHO Global Congress on Implementation of the International Code of Marketing of Breast-Milk Substitutes at WHO headquarters in Geneva.

The meeting was attended by more than 400 government, health, and advocacy representatives from more than 100 countries.  Representatives of infant formula companies were not invited to participate.

Its purpose was to encourage governments to promote and enforce the International Code, which nearly all U.N. member states ratified and committed to in 1981 (the U.S. was a long-standing holdout).

This meant they would control inappropriate marketing of infant formulas by banning advertising to people who are pregnant or nursing, gifts of formula samples, and doing anything to make formula appear superior to breastfeeding.

The logic of the Congress:

• Breastfeeding is the superior method for feeding human babies.
• Successful breastfeeding requires support from families, society, and government.
• It is quite easy to undermine confidence in the ability to breastfeed.
• Formula companies do all they can to undermine confidence in breastfeeding.
• Formula companies’ main goal is to sell more formula.
• Formula companies promote their products as normal and superior.
• Breastfeeding is easier when formula marketing is controlled.y

I talked about the food industry “playbook”—strategies and tactics used by industries (tobacco, chemical, drug, alcohol, and food as well as infant formula) to cast doubt on unfavorable research, fund their own research, and lobby against public health recommendations (photo: Arum Gupta).

Many country representatives discussed the effects of the playbook in their areas, and what they are trying to do to stop formula companies from using  the playbook to get around the Code.

The general consensus:  Formula companies should NOT be allowed to:

• Advertise or market products in violation of the Code.
• Participate in public health policymaking.
• Partner with relevant government agencies or non-governmental groups.

Obviously, formula companies are not happy with such recommendations.  If you would like to see an example of the playbook in action, take a look at the response  from the International Special Dietary Foods Industries.

It was exciting to be with so many people who cared so deeply about this issue.

Resources

• WHO Breastfeeding page
• WHO International Code FAQ
• The Global Breastfeeding Collective

Oxygen nanobubbles?  Oxygen in little tiny bubbles?

For this gem I am indebted to an item I read in NutraIngredients-Europe:

Oxygen nanobubble drink found to enhance athletic performance, study suggestsA new study finds the consumption of an oxygen nanobubble beverage significantly improves the time-to-completion of maximal and submaximal exercises performed by male cyclists…. Read more

I went right to the article.

The study: A Double-Blind, Randomized, Placebo-Controlled Pilot Study examining an Oxygen Nanobubble Beverage for 16.1-km Time Trial and Repeated Sprint Cycling Performance.  Journal of Dietary Supplements. https://doi.org/10.1080/19390211.2023.2203738.

The concept: Athletes need oxygen and water.  Therefore, oxygen-supplemented water should improve performance.

The result: As comparied to placebo, Althletes who consumed the oxygen-nanobubble beverage demonstrated significantly improved performance.

The conclusion:  “An oxygen-nanobubble beverage improves performance during submaximal and repeated sprint cycling, therefore may provide a practical and effective ergogenic aid for competitive cyclists.”

Guess who funded this: “This study was funded by Avrox Technologies Ltd, Harrogate, North Yorkshire, HG3 3SZ. Avrox Technologies provided the experimental beverages but had no role in study design, data storage, analysis and interpretation.

I wondered what the placebo was and whether study subjects could distinguish the drinks.  The beverages:

were supplied by Avrox Technologies in 500 mL individually sealed bottles and consisted of the same solution containing water, glycerol, glycyrrhizin, lecithin and citric acid. Both beverages have similar organoleptic properties, including taste, aroma, and texture. Previous investigations have indicated that the oxygen nanobubble drink consists of a suspension of lecithin vesicles with a modal diameter of ∼100 nm and concentration 7 × 1012 particles/ml.

The authors deal with my question in their discussion of the study’s limitations:

we did not evaluate the success of our double-blind design, therefore, changes in performance might be somewhat attributed to participants’ expectancy of positive outcomes from their belief that they successfully identified the O₂ beverage…Whilst there were no notable differences in taste, texture or appearance of the O₂ and PLA [not spelled out in the study but must refer to the placebo] beverages, we should have assessed blinding via treatment allocation questionnaires to determine whether participant biases influenced results.

Yes, you should have.

I also wonder whether club soda or Pellegrino might have the same benefit?  Or giving water a good shake?

The prolific International Panel of Experts on Sustainable Food Systems has produced another must-see report:

Here’s what it’s about:

Corporate influence over food system governance has become the new normal: the 2021 UN Food Systems Summit exposed the ability of multinational agri-food corporations to influence food system decision-making and dominate seemingly inclusive ‘multi-stakeholder’ processes…corporations have
succeeded in convincing governments that they must be central in any discussion on the future of food systems. Public-private partnerships and ‘multi-stakeholder’ roundtables…have normalized a prominent role for corporations and given them an inside track to decision-making.

Here’s where it’s headed:

To meet the needs of those impacted by  worsening hunger and malnutrition, it will be necessary to address the influence of corporations at all levels, including through a UN-wide Corporate Accountability Framework and robust conflict of interest policies, taking inspiration from World Health Organization frameworks for tobacco control and engagement with non-state actors.

IPES Food is doing great work.  Read their reports!