Evidence map›Paper›PMID 31271875›Full record

ArticleContemporary clinical trials2019

Design and baseline characteristics of the cocoa supplement and multivitamin outcomes study for the Mind: COSMOS-Mind.

Laura D Baker, Stephen R Rapp, Sally A Shumaker, JoAnn E Manson, Howard D Sesso, Sarah A Gaussoin, Darrin Harris, Brad Caudle, Debbie Pleasants, Mark A Espeland and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03035201 (COcoa Supplement and Multivitamin Outcomes Study-Mind), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

NCT03035201 completednot on this map

COcoa Supplement and Multivitamin Outcomes Study-Mind

TypeobservationalSponsorWake Forest University Health SciencesRan2016 to 2021Enrolled2,262ConditionsCognitive Impairment, Dementia, Aging
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Effects of cocoa extract and a multivitamin on cognitive function: A randomized clinical trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2023
    Trial
  5. Article
  6. Article
  7. Review
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.

Laura D BakerDepartment of Internal Medicine, Wake Forest School of Medicine, One Medical Center Boulevard, Winston-Salem, NC, 27157, United States of America; Department of Social Sciences and Health Policy, Wake Forest School of Medicine, One Medical Center Boulevard, Winston-Salem, NC, 27157, United States of America. Electronic address: ldbaker@wakehealth.edu.
Stephen R RappDepartment of Social Sciences and Health Policy, Wake Forest School of Medicine, One Medical Center Boulevard, Winston-Salem, NC, 27157, United States of America; Department of Psychiatry and Prevention, Wake Forest School of Medicine, One Medical Center Boulevard, Winston-Salem, NC, 27157, United States of America. Electronic address: srapp@wakehealth.edu.
Sally A ShumakerDepartment of Social Sciences and Health Policy, Wake Forest School of Medicine, One Medical Center Boulevard, Winston-Salem, NC, 27157, United States of America. Electronic address: sshumake@wakehealth.edu.
JoAnn E MansonDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, and the Department of Epidemiology, Harvard T.H. Chan School of Public Health, 900 Commonwealth Avenue, Boston, MA 02115, United States of America. Electronic address: jmanson@rics.bwh.harvard.edu.
Howard D SessoDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, and the Department of Epidemiology, Harvard T.H. Chan School of Public Health, 900 Commonwealth Avenue, Boston, MA 02115, United States of America. Electronic address: hsesso@hsph.harvard.edu.
Sarah A GaussoinDepartment of Biostatistics and Data Science, Wake Forest School of Medicine, One Medical Center Boulevard, Winston-Salem, NC, 27157, United States of America. Electronic address: sgaussoi@wakehealth.edu.
Darrin HarrisDepartment of Biostatistics and Data Science, Wake Forest School of Medicine, One Medical Center Boulevard, Winston-Salem, NC, 27157, United States of America. Electronic address: dharris@wakehealth.edu.
Brad CaudleDepartment of Social Sciences and Health Policy, Wake Forest School of Medicine, One Medical Center Boulevard, Winston-Salem, NC, 27157, United States of America. Electronic address: bcaudle@wakehealth.edu.
Debbie PleasantsDepartment of Social Sciences and Health Policy, Wake Forest School of Medicine, One Medical Center Boulevard, Winston-Salem, NC, 27157, United States of America. Electronic address: depleasan@wakehealth.edu.
Mark A EspelandDepartment of Biostatistics and Data Science, Wake Forest School of Medicine, One Medical Center Boulevard, Winston-Salem, NC, 27157, United States of America. Electronic address: mespelan@wakehealth.edu.
COSMOS-Mind Research Group

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
VITamin D and omegA-3 triaL (VITAL)U01CA138962 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI BURING, JULIE E., MANSON, JOANN ELISABETH · 2009 to 2014
$23.6M
The VITamin D and OmegA-3 TriaL (VITAL)R01CA138962 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI BURING, JULIE E., MANSON, JOANN ELISABETH · 2015 to 2019
$20.9M
Wake Forest Alzheimer's Disease Core CenterP30AG049638 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI RAPP, STEPHEN R · 2016 to 2020
$12.2M
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
NCATS NIH HHS UL1 TR001102NCI NIH HHS R01 CA138962NCI NIH HHS U01 CA138962NHLBI NIH HHS HHSN268201600001CNHLBI NIH HHS HHSN268201600002CNHLBI NIH HHS HHSN268201600003CNHLBI NIH HHS HHSN268201600004CNHLBI NIH HHS HHSN268201600018CNIA NIH HHS P30 AG049638NIA NIH HHS R01 AG050657
6 · The paper itself

Abstract

backgroundLarge simple trials are potentially efficient and cost-effective approaches to assess interventions to preserve cognitive function in older adults. High-dose cocoa flavanols supplementation is a promising intervention that warrants additional testing. We describe the design, recruitment success, and baseline characteristics of the Cocoa Supplement and Multivitamin Outcomes Study for the Mind (COSMOS-Mind) trial.

methodsCOSMOS-Mind is an ancillary study to the large-scale and predominantly mail-based COSMOS randomized controlled clinical trial. COSMOS is assessing whether cocoa extract (including 600 mg/d cocoa flavanols) and a multivitamin reduce risks for major cardiovascular events and total invasive cancer. COSMOS-Mind uses telephone-based interviews to assess cognitive function and impairment to determine whether cocoa flavanols benefit cognitive function in adults aged 65 years or older, targeting the enrollment of 2000 participants to provide >90% statistical power across 3 years of annual follow-up.

resultsOf the 3224 COSMOS screenees who expressed interest in COSMOS-Mind, 2350 (76%) successfully completed baseline cognitive assessments and 2262 (96%) geographically diverse, eligible individuals were ultimately enrolled over one year. At baseline, the primary outcome, a composite of cognitive test scores, was inversely associated with age in a manner consistent with assumptions used in projections of statistical power.

conclusionsOlder adults are willing to enroll in large simple trials that include telephone-based cognitive assessments. Embedding these trials in large studies of other health outcomes is efficient and expands the scientific knowledge gained from the research. ClinicalTrials.gov Identifiers: NCT03035201 (COSMOS-Mind); NCT102422745 (parent COSMOS).

Indexed as

CacaoDietary SupplementsAgedAged, 80 and overCognitionCognitive DysfunctionDouble-Blind MethodFemaleHumansMaleNeuropsychological TestsPlant ExtractsRandomized Controlled Trials as TopicVitaminsPlant ExtractsVitaminsAgingAlzheimer's diseaseCocoa flavanolsCognitive functionLarge simple trialsMultivitamins

Identifiers

PMID31271875
PMCPMC6642834

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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.