Evidence map›Paper›PMID 37816167›Full record

Trial reportDiabetes care2023

Cocoa Extract Supplementation and Risk of Type 2 Diabetes: The Cocoa Supplement and Multivitamin Outcomes Study (COSMOS) Randomized Clinical Trial.

Jie Li, Howard D Sesso, Eunjung Kim, JoAnn E Manson, Georgina Friedenberg, Allison Clar, Trisha Copeland, Aladdin H Shadyab, Jean Wactawski-Wende, Lesley Tinker and 1 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.0field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 2 countries.

Jie LiDepartment of Epidemiology and Center for Global Cardiometabolic Health, School of Public Health, Brown University, Providence, RI.ORCID 0000-0002-7529-6040
Howard D SessoDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Eunjung KimDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
JoAnn E MansonDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Georgina FriedenbergDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Allison ClarDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Trisha CopelandDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Aladdin H ShadyabHerbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego, La Jolla, CA.
Jean Wactawski-WendeSchool of Public Health and Health Professions, University at Buffalo, Buffalo, NY.
Lesley TinkerDivision of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.
Simin LiuDepartment of Epidemiology and Center for Global Cardiometabolic Health, School of Public Health, Brown University, Providence, RI.ORCID 0000-0003-2098-3844
Brigham and Women's Hospital · USBrown University · USFred Hutch Cancer Center · USUniversity at Buffalo, State University of New York · USUniversity of California San Diego · US

Funding

WOMEN'S HEALTH INITIATIVE - CLINICAL COORDINATING CENTER: TASK AREA B - LONG LIFE STUDY VISIT 2 LIMITED HOME VISIT75N92021D00001 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI ANDERSON, GARNET L. · 2021 to 2025
$52.0M
WOMEN'S HEALTH INITIATIVE (WHI) REGIONAL CENTER (RC): TASK AREA A AND A275N92021D00002 · NHLBI · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI WACTAWSKI-WENDE, JEAN · 2021 to 2025
$6.9M
WOMEN'S HEALTH INITIATIVE (WHI) REGIONAL CENTER (RC) - TO EXERCISE OPTION PERIOD ONE (1) AND REVISE CONTRACT ARTICLES.75N92021D00004 · NHLBI · STANFORD UNIVERSITY · PI STEFANICK, MARCIA · 2021 to 2025
$6.5M
WOMEN'S HEALTH INITIATIVE (WHI) REGIONAL CENTER (RC) - TO EXERCISE OPTION PERIOD ONE (1) AND REVISE CONTRACT ARTICLES.75N92021D00003 · NHLBI · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA · 2021 to 2025
$5.0M
WOMEN'S HEALTH INITIATIVE (WHI) REGIONAL CENTER (RC) - TO EXERCISE OPTION PERIOD ONE (1) AND REVISE CONTRACT ARTICLES.75N92021D00005 · NHLBI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI VITOLINS, MARA · 2021 to 2025
$4.2M
Cocoa Supplement and Multivitamin Outcomes Study in the Mind (COSMOS-Mind)R01AG050657 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI BAKER, LAURA D., ESPELAND, MARK ANDREW · 2016 to 2020
$3.8M
Effect of randomized cocoa supplementation on inflammaging and epigenetic agingR01HL157665 · NHLBI · AUGUSTA UNIVERSITY · PI DONG, YANBIN, SESSO, HOWARD D · 2021 to 2024
$2.9M
COcoa Supplement and Multivitamins Outcomes Study (COSMOS): Effects on Falls and Physical PerformanceR01AG071611 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI CRANDALL, CAROLYN JANET, LEBOFF, MERYL SUSAN · 2021 to 2024
$2.7M
COSMOS Eye: Cataract and AMD in a Trial of a Multivitamin and Cocoa ExtractR01EY025623 · NEI · BRIGHAM AND WOMEN'S HOSPITAL · PI SESSO, HOWARD D · 2016 to 2020
$2.6M
Asprosin, body weight, and risk of type 2 diabetes in U.S. men and womenR01DK125403 · NIDDK · UNIVERSITY OF CALIFORNIA-IRVINE · PI LIU, SIMIN · 2020 to 2022
$2.1M
NEI NIH HHS R01 EY025623NHLBI NIH HHS 75N92021D00001NHLBI NIH HHS 75N92021D00002NHLBI NIH HHS R01 HL157665NIA NIH HHS R01 AG050657NIA NIH HHS R01 AG071611NIH HHS EY025623WHI NIH HHS 75N92021D00003WHI NIH HHS 75N92021D00004WHI NIH HHS 75N92021D00005
6 · The paper itself

Abstract

objectiveObservational studies have indicated that cocoa flavanol supplementation may be a promising strategy for type 2 diabetes (T2D) prevention. We aimed to directly evaluate its clinical efficacy in a large randomized clinical trial (RCT). RESEARCH DESIGN AND

methodThe Cocoa Supplement and Multivitamin Outcomes Study (COMSOS) was a 2 × 2 factorial RCT performed from June 2015 to December 2020 that tested cocoa extract and a multivitamin for the prevention of cardiovascular disease (CVD) and cancer. A total of 21,442 U.S. adults free of CVD and recent cancer, including 12,666 women aged ≥65 years and 8,776 men aged ≥60 years, were randomly assigned to receive cocoa extract [500 mg/day cocoa flavanols, including 80 mg (-)-epicatechin] or placebo. In this study, we included 18,381 participants without diabetes at enrollment and examined the effect of cocoa extract supplementation on incident self-reported T2D in intention-to-treat analyses.

resultsDuring a median follow-up of 3.5 years, 801 incident T2D cases were reported. Compared with placebo, taking a cocoa extract supplement did not reduce T2D (adjusted hazard ratio 1.04, 95% CI 0.91-1.20, P = 0.58). Stratification analyses showed that the effect of cocoa extract supplementation was not significantly modified by sex, race, BMI, smoking, physical activity, dietary quality, flavanol status at baseline, or randomized multivitamin assignment.

conclusionsMiddle-aged and older adults taking a cocoa extract supplement for a median of 3.5 years did not reduce their risk of incident T2D. Further studies of cocoa extract supplementation beginning earlier in adulthood and in populations with different background diets are warranted.

Indexed as

CacaoCardiovascular DiseasesDiabetes Mellitus, Type 2NeoplasmsAgedDietary SupplementsDouble-Blind MethodFemaleHumansMaleMiddle AgedPlant ExtractsVitaminsPlant ExtractsVitamins

Identifiers

PMID37816167
PMCPMC10698212
OpenAlexW4387490647

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.