Cocoa Supplementation, Inflammaging, and Epigenetic Aging

Effect of Randomized Cocoa Supplementation on Inflammaging and Epigenetic Aging

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Inflammation; Aging
• Intervention / Treatment: Dietary supplement: Multivitamin; Dietary supplement: Multivitamin placebo; Dietary supplement: Cocoa extract; Dietary supplement: Cocoa extract placebo

• Study Type: Interventional
• Enrollment (Actual): 21442
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cocoa extract + multivitamin; Two capsules/day for 600 mg/day of cocoa flavanols One tablet/day of multivitamin	Dietary supplement: Multivitamin; Multivitamin; Dietary supplement: Cocoa extract; 2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
Active Comparator: Cocoa extract + multivitamin placebo; Two capsules/day for 600 mg/day of cocoa flavanols Multivitamin placebo	Dietary supplement: Multivitamin placebo; Multivitamin placebo; Dietary supplement: Cocoa extract; 2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
Active Comparator: Cocoa extract placebo + multivitamin; Cocoa extract placebo One tablet/day of multivitamin	Dietary supplement: Multivitamin; Multivitamin; Dietary supplement: Cocoa extract placebo; Cocoa extract placebo
Placebo Comparator: Cocoa extract placebo + multivitamin placebo; Cocoa extract placebo Multivitamin placebo	Dietary supplement: Multivitamin placebo; Multivitamin placebo; Dietary supplement: Cocoa extract placebo; Cocoa extract placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Augusta University
• Collaborators: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): July 1, 2022
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Inflammation
• Other Study ID Numbers: 1687423

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No