Cocoa Supplementation, Inflammaging, and Epigenetic Aging

Phase 4

• Conditions: Cardiovascular Diseases; Aging; Inflammation
• Interventions: Dietary Supplement: Cocoa extract; Dietary Supplement: Multivitamin placebo; Dietary Supplement: Multivitamin; Dietary Supplement: Cocoa extract placebo

• Registration Number: NCT05510375
• Lead Sponsor: Augusta University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2021-09-15
• Primary Completion: 2022-07
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-19
• Last Update Submitted: 2022-08-19
• Study First Posted: 2022-08-22
• Last Update Posted: 2022-08-22
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21442

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Cocoa extract placebo + multivitamin placebo	Multivitamin placebo	Cocoa extract placebo Multivitamin placebo
Cocoa extract + multivitamin	Cocoa extract	Two capsules/day for 600 mg/day of cocoa flavanols One tablet/day of multivitamin
Cocoa extract + multivitamin	Multivitamin	Two capsules/day for 600 mg/day of cocoa flavanols One tablet/day of multivitamin
Cocoa extract placebo + multivitamin	Cocoa extract placebo	Cocoa extract placebo One tablet/day of multivitamin
Cocoa extract + multivitamin placebo	Cocoa extract	Two capsules/day for 600 mg/day of cocoa flavanols Multivitamin placebo
Cocoa extract + multivitamin placebo	Multivitamin placebo	Two capsules/day for 600 mg/day of cocoa flavanols Multivitamin placebo
Cocoa extract placebo + multivitamin	Multivitamin	Cocoa extract placebo One tablet/day of multivitamin
Cocoa extract placebo + multivitamin placebo	Cocoa extract placebo	Cocoa extract placebo Multivitamin placebo

Primary Outcome Measures

Name	Time	Method
Inflammaging	2 years	An index constructed using several inflammation markers reflecting inflammaging.
Epigenetic age acceleration	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Pulse wave velocity	2 years	Pulse wave velocity in m/s from the carotid to the femoral artery will be measured.
Body mass index	2 years	Body mass index in kg/m2 will be calculated using height and weight
Blood pressure	2 years	Systolic and diastolic blood pressure in mmHg.