NCT05510375

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. (-)-epicatechins), and 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 is being conducted among participants in COSMOS and will examine whether the cocoa extract supplement or the multivitamin supplement has an anti-aging effect (epigenetic aging and inflammaging) and examining these findings in the context of CVD risk factors and outcomes.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
21,442

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_4

Status
unknown

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

June 1, 2015

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

7.1 years

First QC Date

September 15, 2021

Last Update Submit

August 19, 2022

Conditions

AgingInflammationCardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

  • Epigenetic age acceleration

    A cumulative epigenetic aging index (DNAm age) that predicts DNAm age will be calculated. The residual from regressing DNAm age on chronological age provides a measure of epigenetic age acceleration.

    2 years

  • Inflammaging

    An index constructed using several inflammation markers reflecting inflammaging.

    2 years

Secondary Outcomes (3)

  • Blood pressure

    2 years

  • Body mass index

    2 years

  • Pulse wave velocity

    2 years

Study Arms (4)

Cocoa extract + multivitamin

ACTIVE COMPARATOR

Two capsules/day for 600 mg/day of cocoa flavanols One tablet/day of multivitamin

Dietary Supplement: Cocoa extractDietary Supplement: Multivitamin

Cocoa extract + multivitamin placebo

ACTIVE COMPARATOR

Two capsules/day for 600 mg/day of cocoa flavanols Multivitamin placebo

Dietary Supplement: Cocoa extractDietary Supplement: Multivitamin placebo

Cocoa extract placebo + multivitamin

ACTIVE COMPARATOR

Cocoa extract placebo One tablet/day of multivitamin

Dietary Supplement: MultivitaminDietary Supplement: Cocoa extract placebo

Cocoa extract placebo + multivitamin placebo

PLACEBO COMPARATOR

Cocoa extract placebo Multivitamin placebo

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
MultivitaminDIETARY_SUPPLEMENT

Multivitamin

Cocoa extract + multivitaminCocoa extract placebo + multivitamin
Cocoa extract placeboDIETARY_SUPPLEMENT

Cocoa extract placebo

Cocoa extract placebo + multivitaminCocoa extract placebo + multivitamin placebo
Multivitamin placeboDIETARY_SUPPLEMENT

Multivitamin placebo

Cocoa extract + multivitamin placeboCocoa extract placebo + multivitamin placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provided blood samples at baseline, Year 1, and Year 2 of follow-up.
  • Opted to use EMSI for longitudinal blood collections, during which seated BPs were additionally measured.

You may not qualify if:

  • Did not collect blood samples at baseline, Year 1, or Year 2 of follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InflammationCardiovascular Diseases

Interventions

ChocolateGeritol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2021

First Posted

August 22, 2022

Study Start

June 1, 2015

Primary Completion

July 1, 2022

Study Completion

September 30, 2023

Last Updated

August 22, 2022

Record last verified: 2022-08