NCT04582617

Brief Summary

The COcoa Supplement and Multivitamin Outcomes Study (COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg (-)-epicatechin), and/or a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. This ancillary study (COSMOS Web) is being conducted among a subset of participants in COSMOS and will examine whether the cocoa extract supplements affects cognitive function in older adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,959

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2016

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2019

Completed
1 year until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

4.4 years

First QC Date

October 2, 2019

Last Update Submit

April 6, 2023

Conditions

AgingCognitive Change

Keywords

Cognitive FunctionCognitive ChangeAgingModReyCocoa ExtractMultivitaminHippocampusExecutive FunctionVerbal MemorySpatial Memory

Outcome Measures

Primary Outcomes (1)

  • ModRey: 1-Year Change in Immediate Recall/Learning/Episodic Memory

    A measure of verbal memory. The change in the number of words recalled immediately on the ModRey task (Hale et al., 2019), after one year of cocoa extract/placebo intervention.

    1-year follow-up

Secondary Outcomes (11)

  • ModRey: Longitudinal Change in Immediate Recall/Learning

    2-year and 3-year follow-ups

  • ModBent

    1-year, 2-year and 3-year follow-ups

  • Flanker: Directional Flanker Effect

    1-year, 2-year and 3-year follow-ups

  • Spatial Reconstruction: Distortion

    1-year, 2-year and 3-year follow-ups

  • Self-Reported Memory Change

    1-year, 2-year and 3-year follow-ups

  • +6 more secondary outcomes

Study Arms (4)

Cocoa extract + multivitamin

ACTIVE COMPARATOR
Dietary Supplement: Cocoa ExtractDietary Supplement: Multivitamin

Cocoa extract + multivitamin placebo

ACTIVE COMPARATOR
Dietary Supplement: Cocoa ExtractDietary Supplement: Multivitamin placebo

Cocoa extract placebo + multivitamin

ACTIVE COMPARATOR
Dietary Supplement: Cocoa Extract PlaceboDietary Supplement: Multivitamin

Cocoa extract placebo + multivitamin placebo

PLACEBO COMPARATOR
Dietary Supplement: Cocoa Extract PlaceboDietary Supplement: Multivitamin placebo

Interventions

Cocoa ExtractDIETARY_SUPPLEMENT

2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine

Cocoa extract + multivitaminCocoa extract + multivitamin placebo
Cocoa Extract PlaceboDIETARY_SUPPLEMENT

Cocoa extract placebo

Cocoa extract placebo + multivitaminCocoa extract placebo + multivitamin placebo
MultivitaminDIETARY_SUPPLEMENT

Multivitamin

Cocoa extract + multivitaminCocoa extract placebo + multivitamin
Multivitamin placeboDIETARY_SUPPLEMENT

Multivitamin placebo

Cocoa extract + multivitamin placeboCocoa extract placebo + multivitamin placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Willingness to participate
  • Email and internet access via computer

You may not qualify if:

  • \* Analog to COSMOS parent trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (5)

  • Brickman AM, Khan UA, Provenzano FA, Yeung LK, Suzuki W, Schroeter H, Wall M, Sloan RP, Small SA. Enhancing dentate gyrus function with dietary flavanols improves cognition in older adults. Nat Neurosci. 2014 Dec;17(12):1798-803. doi: 10.1038/nn.3850. Epub 2014 Oct 26.

    PMID: 25344629BACKGROUND

  • Hale C, Last BS, Meier IB, Yeung LK, Budge M, Sloan RP, Small SA, Brickman AM. The ModRey: An Episodic Memory Test for Nonclinical and Preclinical Populations. Assessment. 2019 Sep;26(6):1154-1161. doi: 10.1177/1073191117723113. Epub 2017 Aug 11.

    PMID: 28799411BACKGROUND

  • Sloan RP, Wall M, Yeung LK, Feng T, Feng X, Provenzano F, Schroeter H, Lauriola V, Brickman AM, Small SA. Insights into the role of diet and dietary flavanols in cognitive aging: results of a randomized controlled trial. Sci Rep. 2021 Feb 15;11(1):3837. doi: 10.1038/s41598-021-83370-2.

    PMID: 33589674BACKGROUND

  • Vyas CM, Manson JE, Sesso HD, Cook NR, Rist PM, Weinberg A, Moorthy MV, Baker LD, Espeland MA, Yeung LK, Brickman AM, Okereke OI. Effect of multivitamin-mineral supplementation versus placebo on cognitive function: results from the clinic subcohort of the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) randomized clinical trial and meta-analysis of 3 cognitive studies within COSMOS. Am J Clin Nutr. 2024 Mar;119(3):692-701. doi: 10.1016/j.ajcnut.2023.12.011. Epub 2024 Jan 18.

    PMID: 38244989DERIVED

  • Yeung LK, Alschuler DM, Wall M, Luttmann-Gibson H, Copeland T, Hale C, Sloan RP, Sesso HD, Manson JE, Brickman AM. Multivitamin Supplementation Improves Memory in Older Adults: A Randomized Clinical Trial. Am J Clin Nutr. 2023 Jul;118(1):273-282. doi: 10.1016/j.ajcnut.2023.05.011. Epub 2023 May 24.

    PMID: 37244291DERIVED

MeSH Terms

Interventions

ChocolateGeritol

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Adam M. Brickman, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 9, 2020

Study Start

August 26, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 7, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Researchers interested in study data may contact the study principal investigators to request access. Data requests must be submitted in writing for approval by qualified individuals; they will be reviewed by study investigators. External investigators who are granted access to data for analysis must identify a Cosmos Web investigator, who will participate in analyses and manuscript preparation as a co-author. Researchers interested in accessing data related to the Cosmos parent trial (NCT02422745) should contact the administrators of that study.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After completion of study
Access Criteria
Cosmos-Web Project Proposal Form Approved by Dr. Brickman

Locations

US(2)