Evidence map›Paper›PMID 38070683›Full record

Trial reportThe American journal of clinical nutrition2024

Effect of cocoa extract supplementation on cognitive function: results from the clinic subcohort of the COSMOS trial.

Chirag M Vyas, JoAnn E Manson, Howard D Sesso, Pamela M Rist, Alison Weinberg, Eunjung Kim, M Vinayaga Moorthy, Nancy R Cook, Olivia I Okereke

Registry-linked trialOpen access · greenAbstract readClinical Trial
In one paragraph

Trial report in The American journal of clinical nutrition, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02422745 (COcoa Supplement and Multivitamin Outcomes Study), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 6% 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.

NCT02422745 phase4completednot on this map

COcoa Supplement and Multivitamin Outcomes Study

TypeinterventionalSponsorBrigham and Women's HospitalRan2015 to 2023Enrolled21,442ConditionsCardiovascular Disease, CancerArmsCocoa extract, Multivitamin, Cocoa extract placebo, Multivitamin placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Review
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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

9 authors at 2 institutions in 1 country.

Chirag M VyasDepartment of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States. Electronic address: cvyas@mgb.org.
JoAnn E MansonDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States; Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA, United States; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States.
Howard D SessoDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States; Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA, United States.
Pamela M RistDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States; Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA, United States.
Alison WeinbergDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States.
Eunjung KimDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States.
M Vinayaga MoorthyDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States.
Nancy R CookDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States; Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA, United States.
Olivia I OkerekeDepartment of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States; Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA, United States; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States.
Brigham and Women's Hospital · USHarvard University · US

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
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
NCATS NIH HHS UL1 TR001102NEI NIH HHS R01 EY025623NHLBI NIH HHS 75N92021D00001NHLBI NIH HHS 75N92021D00002NHLBI NIH HHS R01 HL157665NIA NIH HHS R01 AG050657NIA NIH HHS R01 AG071611WHI NIH HHS 75N92021D00003WHI NIH HHS 75N92021D00004WHI NIH HHS 75N92021D00005
6 · The paper itself

Abstract

backgroundSome prior randomized clinical trials (RCTs) that tested the effects of cocoa extract (CE), a source of flavanols, on late-life cognition have yielded promising findings. A long-term RCT using in-person neuropsychological tests covering multiple cognitive domains may clarify the cognitive effects of CE.

objectivesTo test whether daily supplementation with CE, compared with placebo, produces better cognitive change over 2 y.

methodsThe COcoa Supplement and Multivitamin Outcomes Study (COSMOS) is a 2 × 2 factorial RCT of CE [500 mg flavanols/d, including 80 mg (-)-epicatechin] and/or a daily multivitamin-mineral supplement for cardiovascular disease and cancer prevention among 21,442 United States adults aged ≥60 y. There were 573 participants in the clinic subcohort of COSMOS (that is, COSMOS-Clinic) who completed all cognitive tests at baseline; of these, 492 completed 2-y follow-up assessments. The primary outcome was global cognition (averaging z-scores across 11 tests). Secondary outcomes were episodic memory and executive function/attention. Repeated measures models were used to compare randomized groups.

resultsParticipants' mean age (standard deviation) was 69.6 (5.3); 49.2% were females. Daily supplementation with CE, compared with placebo, had no significant effect on 2-y change in global cognition {mean difference [95% confidence interval (CI)]: -0.01 (-0.08, 0.05) standard deviation units (SU)}. CE, compared with placebo, had no significant effects on 2-y change in episodic memory [mean difference (95% CI): -0.01 (-0.13, 0.10) SU] or executive function/attention [mean difference (95% CI): 0.003 (-0.07, 0.08) SU]. Subgroup analyses uncorrected for multiple-testing suggested cognitive benefits of CE supplementation, compared with placebo among those with poorer baseline diet quality.

conclusionsAmong 573 older adults who underwent repeat in-person, detailed neuropsychological assessments over 2 y, daily CE supplementation, compared with placebo, showed no overall benefits for global or domain-specific cognitive function. Possible cognitive benefits of CE among those with poorer diet quality warrant further study.

trial registrationThis trial was registered at clinicaltrials.gov with identifier - NCT02422745.

Indexed as

CacaoVitaminsAgedCognitionDietary SupplementsDouble-Blind MethodExecutive FunctionFemaleHumansMaleVitaminscocoa extractcognitionflavanolsgeriatricrandomized clinical trial

Identifiers

PMID38070683
PMCPMC11347806
OpenAlexW4389433571

What OpenQuestion holds

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Registered trials

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.