by Marion Nestle

Currently browsing posts about: Conflicts-of-interest

Jul 20 2023

Ultra-processed pushback #4: a debate

The British journal, Public Health Nutrition, published a debate about ultra-processed foods this month.

Invited commentaries

CON:  Michael Gibney.  Ultra-processed foods in public health nutrition: the unanswered questions,

Several definitions of the degree of processing have been proposed. However, when each of these is used on a common database of nutritional, clinical and anthropometric variables, the observed effect of high intakes of highly processed food, varies considerably.. Moreover, assigning a given food by nutritional experts, to its appropriate level of processing, has been shown to be variable. Thus, the subjective definitions of the degree of food processing and the coding of foods according to these classifications is prone to error…Another issue that need[s] resolution is the relative importance of the degree of food processing and the formulation of a processed food. Although correlational studies linking processed food and obesity abound, there is a need for more investigative studies.

PRO: Mark Lawrence.  Ultra-processed foods: a fit-for-purpose concept for nutrition policy activities to tackle unhealthy and unsustainable diets.  Also an addendum: Ultra-processed foods: a fit-for-purpose concept for nutrition policy activities to tackle unhealthy and unsustainable diets.

This commentary describes the UPF concept as being fit-for-purpose in providing guidance to inform policy activities to tackle unhealthy and unsustainable diets. There is now a substantial body of evidence linking UPF exposure with adverse population and planetary health outcomes. The UPF concept is increasingly being used in the development of food-based dietary guidelines and nutrition policy actions. It challenges many conventional nutrition research and policy activities as well as the political economy of the industrial food system. Inevitably, there are politicised debates associated with UPF and it is apparent a disproportionate number of articles claiming the concept is controversial originate from a small number of researchers with declared associations with UPF manufacturers.

Letters to the editor

CON: Mark J Messina, John L Sievenpiper, Patricia Williamson, Jessica Kiel, John W Erdman.  Ultra-processed foods: a concept in need of revision to avoid targeting healthful and sustainable plant-based foods

we take issue with his perspective on our recently published article in which we make two fundamental points. First, the common criticisms of ultra-processed foods (UPF) do not apply to soya-based meat and dairy alternatives more so than they do to their animal-based counterparts, meat and cows’ milk, despite the former being classified as UPF and the latter as unprocessed/minimally processed foods. Second, NOVA is overly simplistic and does not adequately evaluate the nutritional attributes of meat and dairy alternatives based on soya….We therefore stand by our opinion that NOVA does a disservice to the public by suggesting that because soya burgers and soyamilk are NOVA-classified as UPF, they should be avoided. These foods can aid in the transition to and maintenance of plant-based diets.

PRO:  Mark Lawrence. The need for particular scrutiny of claims made by researchers associated with ultra-processed food manufacturers.

In this Commentary, I referred to challenges the UPF concept presents to researchers with declared associations with UPF manufacturers. The interplay between nutrition research and commercial interests is a widely recognised phenomenon in the commercial determinants of health literature…UPF-related research has become highly politicised and the integrity of the claims presented by researchers associated with UPF manufacturers demands close scrutiny.

Comment

In his letter, Mark Lawrence noted my having included the paper by Messina et al as one of my “industry-funded studies of the week” on this website.  In it, I reproduced the unusually long conflict of interest declaration of the authors, many of them disclosing ties to companies making ultra-processed foods.  Again, the ultra-processed concept is backed up by an extraordinary amount of research far beyond the point where it can be ignored or dismissed out of hand.

Professor Lawrence explains why there is so much pushback: “It [the UPF concept] challenges many conventional nutrition research and policy activities as well as the political economy of the industrial food system.”

Jul 18 2023

Ultra-processed pushback #2: The UK’s Scientific Advisory Committee

The U.K.’s Scientific Advisory Committee on Nutrition (SACN) has released its statement on ultra-processed foods.

It dealt with the NOVA classification system (the one I used in yesterday’s post to define ultra-processed foods).  The committee does not like it much.

Assessment beyond the initial screen identified that the literature is currently dominated by NOVA, raising the risk that any limitations or biases present within the NOVA classification system may be replicated throughout the research literature.
While NOVA also met criterion 2 on a clear, usable definition and criterion 4 on the availability of data on inter-assessor agreement, assessment beyond the initial screen dentified less certainty on the clarity, reliability and feasibility of the system.

The SACN’s conclusions:

The SRs identified have consistently reported that increased consumption of (ultra-) processed foods was associated with increased risks of adverse health outcomes. However, there are uncertainties around the quality of evidence available. Studies are almost exclusively observational and confounding factors or key variables such as energy intake, body mass index, smoking and socioeconomic status may not be adequately accounted for.

…In particular, the classification of some foods is discordant with nutritional and other food-based classifications. Consumption of (ultra-) processed foods may be an indicator of other unhealthy dietary patterns and lifestyle behaviours. Diets high in (ultra-) processed foods are often energy dense, high in saturated fat, salt or free sugars, high in processed meat, and/or low in fruit and vegetables and fibre.

…The observed associations between higher consumption of (ultra-) processed foods and adverse health outcomes are concerning – however, the limitations in the NOVA classification system, the potential for confounding, and the possibility that the observed adverse associations with (ultra-) processed foods are covered by existing UK dietary recommendations mean that the evidence to date needs to be treated with caution.

Comment: Kevin Hall  et al’s well controlled clinical trial of ultra-processed versus merely processed diets is neither discussed nor cited in this statement.  Once again, I have no personal knowledge of how this statement was developed, but the U.K.s Soil Association has published a statement with the provocative title, Sticky fingers of food industry on government ultra-processed food review.

While we’re pleased that SACN has prioritised this review, and has acknowledged that ultra-processed foods are of “concern”, we’re disturbed that the committee’s conclusions may have been skewed by industry ties, conflicted financial interests, and a narrow framing of the science.

…But the committee is also guilty of losing the wood for the trees, failing even to raise concern about how ultra-processed foods have overtaken their own nutritional advice….Most people in the UK are failing to eat such a [healthy] diet, precisely because these foods have been displaced by ultra-processed products. The average child’s diet is more than 60% ultra-processed, and rates of obesity and ill health are rising sharply in turn. …SACN is oddly silent on case for re-balancing the diet and addressing the corporate capture of children’s food.

These omissions should prompt us to look more closely at the composition of the committee. SACN has sixteen members. One is a paid consultant working for Cargill, Tate & Lyle, and CBC Israel (a manufacturer and marketer of fizzy drinks such as Coca-Cola and Sprite); two are in receipt of funding from the meat and dairy industry; one is a shareholder in Sainsbury’s; and five are members of the American Society of Nutrition, which is funded by Mars, Nestlé, and Mondelez. Among SACN’s members is the Chair of International Life Sciences Institute (ILSI) Europe, a body that receives funding from some of the world’s largest food companies, such as Barilla, Cargill, Danone, General Mills, Mondelez, and PepsiCo; and two individuals with financial relationships with the British Nutrition Foundation, an organisation funded by British Sugar, Cargill, Coca Cola, Danone, Greggs, Kellogg, KP Snacks, Mars, McDonald’s, Mondelez, Nestlé, PepsiCo, Tate & Lyle, and Tesco. Two SACN members have been funded by Danone, one of the largest ultra-processed food companies in the world; one sits on the council of the Nestlé Foundation; and another is a former employee of Unilever, with current shares in the company worth “more than £5000”.

These declared interests do not imply corruption or bias on the part of SACN members, but they illustrate how pervasive are industry ties at the interface of science and policy.

Jul 17 2023

Industry-influenced study of the week: Ultra-processed foods are good for you!

I am devoting this week to the pushback against advice to reduce consumption of ultra-processed foods.  It is coming from the food industry, of course, government agencies with ties to the food industry, and nutritionists who focus on  the benefits of nutrients, without contextualizing the foods and diets they come from (“nutritionism”).

For the record, ultra-processed foods are :

  • Industrially produced
  • Bear little resemblance to the foods they were derived from
  • Typically contain additives for color, flavor, and texture
  • Cannot be made in home kitchens,
  • Are formulated to be irresistable,
  • Are associated with excessive calorie intake and poor health
  • Are extremely profitable to their makers
  • Cannot be made in home kitchens (a brief operating definition)

Ultra-processed food pushback #1: A study from the USDA and authors with conflicted interests

The USDA’s Agricultural Research Service is so proud of this study that it sent out a press release.

Scientists at the USDA Agricultural Research Service’s (ARS) Grand Forks Human Nutrition Research Center led a study that demonstrates it is possible to build a healthy diet with 91 percent of the calories coming from ultra-processed foods (as classified using the NOVA scale) while still following the recommendations from the 2020-2025 Dietary Guidelines for Americans (DGA). The study highlights the versatility of using DGA recommendations in constructing healthy menus.

The Study: Dietary Guidelines Meet NOVA: Developing a Menu for A Healthy Dietary Pattern Using Ultra-Processed Foods.  Julie M. Hess, Madeline E. Comeau, Shanon Casperson, Joanne L. Slavin, Guy H. Johnson, Mark Messina, Susan Raatz, Angela J. Scheett, Anne Bodensteiner, Daniel G. Palmer.  The Journal of Nutrition, 2023.  https://doi.org/10.1016/j.tjnut.2023.06.028.

Purpose: “The purpose of this proof-of-concept study was to determine the feasibility of building a menu that aligns with recommendations for a healthy dietary pattern from the 2020 DGA and includes ≥80% kcal from UPF as defined by NOVA.”

Method: “we first developed a list of foods that fit NOVA criteria for UPF, fit within dietary patterns in the 2020 DGA, and are commonly consumed by Americans. We then used these foods to develop a 7-d, 2000 kcal menu modeled on MyPyramid sample menus and assessed this menu for nutrient content as well as for diet quality using the Healthy Eating Index-2015 (HEI-2015).”

Results: “In the ultra-processed DGA menu that was created, 91% of kcal were from UPF, or NOVA category 4. The HEI-2015 score was 86 out of a possible 100 points.”

Conclusions: “Healthy dietary patterns can include most of their energy from UPF, still receive a high diet quality score, and contain adequate amounts of most macro- and micronutrients.”

 Conflicts of Interest: “MM serves as the Director of Nutrition Science and Research for the Soy Nutrition Institute (SNI) Global. The SNI Global receives funding from soybean farmers via the soybean national checkoff program and via membership dues from companies involved in manufacturing and/or selling soy ingredients and/or soyfoods. GHJ serves as Senior Advisor to the McCormick Science Institute. JLS serves on advisory/consultant boards for Simply Good Foods, Quality Carbohydrates Coalition, and the Sustainable Nutrition Scientific Board and has received funding from the National Institutes of Health, Taiyo, Barilla Foods, and the USDA in the past 12 mo. The other authors report no conflicts of interest.”

Funding: This work was supported by USDA Agricultural Research Service project grant #3062-51000-057-00D.

Comment:  I can think of only one reason for doing a study like this: to cast doubt on the concept of ultra-processed foods (UPF) and all the research showing that UPF diets induce people to eat more calories (see the study by Kevin Hall et al) and are strongly associated in hundreds of studies with poor health, evidence that by this time is overwhelming and incontrovertible.  Why now?  Because the 2025-2030 Dietary Guidelines Advisory Committee has been charged with examining the relationship of UPF to heart disease risk.

The first rule of the ‘Playbook” is to cast doubt on the research, which is what we are seeing here.  The message to reduce consumption of ultra-processed foods makes good sense for health reasons.  But such advice is very bad for the profits of food companies making junk foods.

The USDA’s Agricultural Research Service is a marketing arm of the food industry,.  It is heavily conflicted.

For one thing, the Healthy Eating Index is not useful for this purpose; it is strictly nutrient-based, which is not the issue here.  And the Dietary Guidelines are careful to leave plenty of room for eating junk foods and to say not one word about UPF.

I think the UPF concept is so solidly backed up by evidence that it is here to stay.  But it is so threatening to food companies making UPF products, and the USDA is so captured by the food industry (checkoff programs, anyone?) that it is understandable why they are so eager to cast doubt.

Thanks to the half dozen or so readers who sent this one to me, to Ted Kyle for calling it “oxymoronic healthy eating,” and  Kevin Hall for pointing out that the healthfulness of this diet is assumed, not tested:

Jul 3 2023

Industry-funded study of the week: “Memphenol”

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?

Jun 12 2023

Industry-funded study of the week: meat, the microbiome, and cardiovascular risk

Christina Leffel, a public health nutritionist in Florida, sent this one, which with both find amusing.

The study: Effects of Adding Lean Red Meat to a U.S.-Style Healthy Vegetarian Dietary Pattern on Gut Microbiota and Cardiovascular Risk Factors in Young Adults: a Crossover Randomized Controlled Trial – The Journal of Nutrition.  VOLUME 153, ISSUE 5P1439-1452, MAY 2023, https://doi.org/10.1016/j.tjnut.2023.03.013

Method:  19 participants consumed 3 study diets in random order: 1) healthy lacto-ovo vegetarian diet (LOV); 2) LOV plus 3 ounces/d of cooked unprocessed lean red meat (URM); and 3) LOV plus 3 ounces/d of cooked processed lean red meat (PRM). Measures: Fecal and fasting blood samples.

Results: The addition of unprocessed or processed lean red meats to a LOV HDP did not influence short-term changes in bacterial taxonomic composition.  When the data from all three diets were combined, “changes in some bacteria were associated with improvements in TC, LDL-C, triglycerides, and HDL-C concentrations, and TC/HDL-C ratio.”

Conclusions:  Healthy young adults who adopt an HDP that may be vegetarian or omnivorous, including lean red meat, experience short-term changes in gut microbial composition, which associate with improvements in multiple lipid-related cardiovascular risk factors.

Funding: “The study was cofunded by the Pork Checkoff, North Dakota Beef Commission, Beef Checkoff, and Foundation for Meat and Poultry Research and Education. The supporting sources had no role in study design; collection, analysis, and interpretation of data; writing of the report; or submission of the report for publication.

Author disclosures: “During the time this review was conducted, WWC received funding for research grants, travel or honoraria for scientific presentations, or consulting services from the following organizations: U.S. National Institutes of Health, U.S. Department of Agriculture (Hatch Funding), Pork Checkoff, National Pork Board, Beef Checkoff, North Dakota Beef Commission, National Cattlemen’s Beef Association, Foundation for Meat and Poultry Research and Education, American Egg Board, Whey Protein Research Consortium, National Dairy Council, Barilla Group, Mushroom Council, and the National Chicken Council. Additionally, SRL received funding for research grants, travel or honoraria for scientific presentations, or consulting services from the following organizations: U.S. National Institutes of Health, U.S. Department of Agriculture, National Science Foundation, Showalter Research Trust, Grain Foods Foundation, CP Kelco US, OLIPOP, Inc, Council for Responsible Nutrition. YW, T-WLC, MT, and CMC declare no conflict of interest. The funder and these other organizations had no role in the design and conduct of the study, analysis, interpretation of the results, and writing of the manuscript.”

Comment: This is yet another industry-funded study in which the funder claims no role–a statement that always makes me laugh.  That’s what they all say, despite much evidence that the funding influence in such situations can be considerable, although unrecognized.  For details, see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

The meat industry, apparently, is trying to convince vegetarians that they can eat any kind of meat they want and not affect their cardiovascular risk.  This, of course, contradicts tons of other evidence, including associations with cancer risk.  These risks may not be mediated through the microbiome, however.  What this study says is that if you are worried about the risks of meat, you don’t have to worry that it changes your microbiome much, at least under the conditions of this study.

Jun 8 2023

New report on conflicts of interest in health research

Sponsor Influences on the Quality and Independence of Health Research: Proceedings of a Workshop
This report summarizes the proceedings of a workshop on the effects of industry funding in biasing health—and, therefore, food and nutrition—research.

The workshop covered the ways that funding sources (especially corporate funders) influence research quality and outcomes (precisely the topic of my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

The report is a succinct yet thorough summary of the research on the effects of funding on research design, outcome, and interpretation.

Some of the speakers:

This report is a great place to begin if the topic is new to you.

And so is this, of course.

Jun 5 2023

Conflicted interest of the week: multivitamins and memory

Here’s another one that several readers have asked me about: Multivitamin Supplementation Improves Memory in Older Adults: A Randomized Clinical Trial.  Authors: American Journal of Clinical Nutrition. DOI:https://doi.org/10.1016/j.ajcnut.2023.05.011

The study: “Participants were randomly assigned to a daily multivitamin supplement (Centrum Silver) or placebo and evaluated annually with an Internet-based battery of neuropsychological tests for 3 y.”  Primary outcome measure: change in episodic memory (immediate recall performance on the ModRey test, after 1 y of intervention).  Secondary outcome measures: changes in episodic memory over 3 y of follow-up,  and in performance on neuropsychological tasks of novel object recognition and executive function over 3 y.

Results: “Compared with placebo, participants randomly assigned to multivitamin supplementation had significantly better ModRey immediate recall at 1 y, the primary endpoint (t(5889) = 2.25, P = 0.025), as well as across the 3 y of follow-up on average (t(5889) = 2.54, P = 0.011). Multivitamin supplementation had no significant effects on secondary outcomes…we estimated that the effect of the multivitamin intervention improved memory performance above placebo by the equivalent of 3.1 y of age-related memory change.”

Conlusion: “Daily multivitamin supplementation, compared with placebo, improves memory in older adults.”

Conflict of interest: HDS, JEM, and AMB received investigator-initiated grant support to their institutions from Mars Edge. Pfizer Consumer Healthcare (now Haleon) provided support through the partial provision of study pills and packaging. HDS received 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 the
American Society of Nutrition during the conduct of the study. No funding sources had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and the decision to submit the manuscript for publication.

Funding: This work was supported by an investigator-initiated grant from Mars Edge, a segment of Mars Inc dedicated to nutrition research. Pfizer Consumer Healthcare (now Haleon) provided support through the
partial provision of study pills and packaging.

Comment:  This study continues to surprise me.  As I’ve written before, it is part of the COSMOS trial, which is also supported by grants from NIH and a private foundation.  In my previous post on it, I noted that despite being funded by Pfizer (which makes Centrum Silver multivitamin supplements), the study did not show benefits of the supplement for prevention of cardiovascular disease or cancer—a rare exception to the rule that industry-funded studies tend to favor the sponsor’s interests.  But here we go again, this time with an equally surprising result but for a different reason: most multivitamin studies have shown no benefits whereas this one says if you take Centrum Silver, it will give you another three years of no loss in memory.  Wow!  I’ll be Pfizer is thrilled.

Here’s what the NIH National Center for Complementary and Integrative Health says about multivitamins:

Multivitamins/multiminerals (MVMs) are the most frequently used dietary supplements, with close to half of American adults taking them. MVMs cannot take the place of eating a variety of foods that are important to a healthy diet. Foods provide more than vitamins and minerals. Many foods also have fiber and other substances that can provide health benefits. However, some people who don’t get enough vitamins and minerals from food alone, or who have certain medical conditions, might benefit from taking one or more of these nutrients found in single-nutrient supplements or in MVMs. However, evidence to support their use for overall health or disease prevention in the general population remains limited.

Some of its conclusions:

  • Most individuals can get all of the necessary vitamins and minerals through a healthy eating pattern of nutrient-dense foods.
  • Taking an MVM increases overall nutrient intake and helps some people get the recommended amounts of vitamins and minerals when they can’t or don’t get them from food alone.
  • There’s no standard or regulatory definition for MVMs, or any dietary supplement, as to what nutrients they must contain or at what levels. .
  • People with healthier diets and lifestyles are more likely to take dietary supplements, making it hard to identify any benefits from their use. There’s no convincing evidence that MVMs help prevent chronic disease.

We will see whether this study causes the Center to change any of this.

May 29 2023

Industry-funded study of the week: kiwi fruit this time

Thanks to Bradley Flansbaum for sending this one from a journal not on my usual reading list: “In persons with constipation or IBS-C, kiwifruit vs. psyllium increased spontaneous bowel movements.”

I like the way this press release gets right to the point.

An industry-funded randomized trial assessed the effect of daily consumption of kiwifruit versus psyllium on GI function and comfort in 184 adults who were healthy, had functional constipation (FC), or met Rome III diagnostic criteria for constipation-predominant irritable bowel syndrome (IBS-C).

The study: Consumption of 2 Green Kiwifruits Daily Improves Constipation and Abdominal Comfort—Results of an International Multicenter Randomized Controlled TrialThe American Journal of Gastroenterology ():10.14309/ajg.0000000000002124, January 9, 2023. | DOI: 10.14309/ajg.0000000000002124.

Authors: Gearry, Richard MD, PhD; Fukudo, Shin MD, PhD; Barbara, Giovanni MD; Kuhn-Sherlock, Barbara PhD; Ansell, Juliet PhD; Blatchford, Paul PhD; Eady, Sarah MSc; Wallace, Alison PhD; Butts, Christine PhD; Cremon, Cesare MD; Barbaro, Maria Raffaella PhD; Pagano, Isabella MD; Okawa, Yohei PhD; Muratubaki, Tomohiko PhD; Okamoto, Tomoko PhD; Fuda, Mikiko MS; Endo, Yuka MD; Kano, Michiko MD, PhD; Kanazawa, Motoyori MD, PhD; Nakaya, Naoki PhD; Nakaya, Kumi PhD; Drummond, Lynley BTech (Hons)

Summary of the study

Methods: Participants included healthy controls (n = 63), patients with functional constipation (FC, n = 60), and patients with constipation-predominant irritable bowel syndrome (IBS-C, n = 61) randomly assigned to consume 2 green kiwifruits or psyllium (7.5 g) per day for 4 weeks, followed by a 4-week washout, and then the other treatment for 4 weeks. The primary outcome was the number of complete spontaneous bowel movements (CSBM) per week.

Results: Consumption of green kiwifruit was associated with a clinically relevant increase of ≥ 1.5 CSBM per week (FC; 1.53, P < 0.0001, IBS-C; 1.73, P = 0.0003) and significantly improved measures of GI comfort (GI symptom rating scale total score) in constipated participants (FC, P < 0.0001; IBS-C, P < 0.0001).

Conclusion: This study provides original evidence that the consumption of a fresh whole fruit has demonstrated clinically relevant increases in CSBM and improved measures of GI comfort in constipated populations. Green kiwifruits are a suitable dietary treatment for relief of constipation and associated GI comfort.

Financial support: Zespri International Ltd. was the principal sponsor and reviewed, approved, and funded the study design. The New Zealand study center trial was jointly funded by a grant from the New Zealand government (Contract C11X1312) and the sponsor company, Zespri International Ltd. In Italy and Japan, Zespri International Ltd. was the sole funder for each study center trial. The funder did not contribute to the study design or data analysis.

Potential competing interests: J.A. and P.B. are employed by Zespri International who part-funded the study. R.G. and L.D. sit on the Science Advisory Board, have received travel and research grants from Zespri International. SF and GB have received research travel grants from Zespri International.

Comment:  Can you guess what Zespri International sells?  Go on.  Take a wild guess.  I’ll admit it.  I’d go for kiwi over psyllium every time.  But we are talking here about an average improvement of 1.5 bowel movements a week, which may or may not be clinically meaningful..  I do give the authors credit for claiming a benefit for “fresh whole fruit,” not specifically kiwifruit.  The study didn’t compare kiwi to other fruits (and why would it, given the kiwi fruit sponsor).  But overall, this is yet another study done for marketing far more than scientific purposes.