Cocoa Supplementation, Inflammaging, and Epigenetic Aging

NCT ID: NCT05510375

Last Updated: 2022-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

21442 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aging Inflammation Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cocoa extract + multivitamin

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

Group Type ACTIVE_COMPARATOR

Cocoa extract

Intervention Type DIETARY_SUPPLEMENT

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

Multivitamin

Intervention Type DIETARY_SUPPLEMENT

Multivitamin

Cocoa extract + multivitamin placebo

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

Group Type ACTIVE_COMPARATOR

Cocoa extract

Intervention Type DIETARY_SUPPLEMENT

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

Multivitamin placebo

Intervention Type DIETARY_SUPPLEMENT

Multivitamin placebo

Cocoa extract placebo + multivitamin

Cocoa extract placebo One tablet/day of multivitamin

Group Type ACTIVE_COMPARATOR

Multivitamin

Intervention Type DIETARY_SUPPLEMENT

Multivitamin

Cocoa extract placebo

Intervention Type DIETARY_SUPPLEMENT

Cocoa extract placebo

Cocoa extract placebo + multivitamin placebo

Cocoa extract placebo Multivitamin placebo

Group Type PLACEBO_COMPARATOR

Cocoa extract placebo

Intervention Type DIETARY_SUPPLEMENT

Cocoa extract placebo

Multivitamin placebo

Intervention Type DIETARY_SUPPLEMENT

Multivitamin placebo

Interventions

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Cocoa extract

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

Intervention Type DIETARY_SUPPLEMENT

Multivitamin

Multivitamin

Intervention Type DIETARY_SUPPLEMENT

Cocoa extract placebo

Cocoa extract placebo

Intervention Type DIETARY_SUPPLEMENT

Multivitamin placebo

Multivitamin placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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1687423

Identifier Type: -

Identifier Source: org_study_id

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