Cocoa Supplementation, Inflammaging, and Epigenetic Aging

• Sponsor: Augusta University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05510375
• Collaborator: Brigham and Women's Hospital (Other)
• Enrollment: 21,442
• Arms: 4
• Anticipated Duration (Months): 100

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging; Inflammation; Cardiovascular Diseases	Dietary Supplement: Cocoa extract; Dietary Supplement: Multivitamin; Dietary Supplement: Cocoa extract placebo; Dietary Supplement: Multivitamin placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 21442 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effect of Randomized Cocoa Supplementation on Inflammaging and Epigenetic Aging
• Actual Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

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: Cocoa extract; 2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine; Dietary Supplement: Multivitamin; Multivitamin
Active Comparator: Cocoa extract + multivitamin placebo Two capsules/day for 600 mg/day of cocoa flavanols 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; Dietary Supplement: Multivitamin placebo; Multivitamin placebo
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: Cocoa extract placebo; Cocoa extract placebo; Dietary Supplement: Multivitamin placebo; Multivitamin placebo

Outcome Measures

Primary Outcome Measures

1. 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.

2. Inflammaging [2 years]

   An index constructed using several inflammation markers reflecting inflammaging.

Secondary Outcome Measures

1. Blood pressure [2 years]

   Systolic and diastolic blood pressure in mmHg.

2. Body mass index [2 years]

   Body mass index in kg/m2 will be calculated using height and weight

3. Pulse wave velocity [2 years]

   Pulse wave velocity in m/s from the carotid to the femoral artery will be measured.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Augusta University
• Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Augusta University
• ClinicalTrials.gov Identifier: NCT05510375
• Other Study ID Numbers: 1687423
• First Posted: Aug 22, 2022
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases; Inflammation

Study Results

No Results Posted as of Aug 22, 2022