NCT04582617: COSMOS-Web

Investigating the Effects of Cocoa Flavanol on Cognition Assessed Online

Completed NA Last updated 7 April 2023

What this trial tests

NA trial testing Cocoa Extract in Aging in 3,959 participants. Completed in 31 December 2020.

Timeline

26 August 2016

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	prevention
Enrollment	3,959
Start date	26 August 2016
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	2 locations across United States

Drugs / interventions tested

• Cocoa Extract
• Cocoa Extract Placebo
• Multivitamin — full drug profile →
• Multivitamin placebo

Conditions studied

• Aging — all drugs for Aging →
• Cognitive Change — all drugs for Cognitive Change →

Sponsor

Columbia University

Who can join

65 and older, any sex, with Aging or Cognitive Change. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Roles of Oxidative Stress in Synaptic Dysfunction and Neuronal Cell Death in Alzheimer's Disease.
   Plascencia-Villa G, Perry G. · · 2023 · cited 84× · PMID 37627623 · DOI 10.3390/antiox12081628
2. Dietary flavanols restore hippocampal-dependent memory in older adults with lower diet quality and lower habitual flavanol consumption.
   Brickman AM, Yeung LK, Alschuler DM, Ottaviani JI, et al · · 2023 · cited 34× · PMID 37252983 · DOI 10.1073/pnas.2216932120
3. The Molecular Mechanism of Polyphenols in the Regulation of Ageing Hallmarks.
   Pereira QC, Dos Santos TW, Fortunato IM, Ribeiro ML. · · 2023 · cited 31× · PMID 36982583 · DOI 10.3390/ijms24065508
4. Multivitamin Supplementation Improves Memory in Older Adults: A Randomized Clinical Trial.
   Yeung LK, Alschuler DM, Wall M, Luttmann-Gibson H, et al · · 2023 · cited 30× · PMID 37244291 · DOI 10.1016/j.ajcnut.2023.05.011
5. Design and baseline characteristics of participants in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS).
   Rist PM, Sesso HD, Johnson LG, Aragaki AK, et al · · 2022 · cited 29× · PMID 35288332 · DOI 10.1016/j.cct.2022.106728
6. 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.
   Vyas CM, Manson JE, Sesso HD, Cook NR, et al · · 2024 · cited 22× · PMID 38244989 · DOI 10.1016/j.ajcnut.2023.12.011
7. Anatomical biology guides a search for nutrients for the aging brain.
   Lauriola V, Brickman AM, Sloan RP, Small SA. · · 2023 · cited 2× · PMID 36372583 · DOI 10.1016/j.mam.2022.101154