Cocoa Supplementation, Inflammaging, and Epigenetic Aging

Cardiovascular Diseases Clinical Trial

Official title:

Effect of Randomized Cocoa Supplementation on Inflammaging and Epigenetic Aging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05510375
• Other study ID #: 1687423
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 2015
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2022
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21442
• Est. completion date: September 30, 2023
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Cardiovascular Diseases
• Inflammation

Intervention

Dietary Supplement:
• Cocoa extract
2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
• Multivitamin
Multivitamin
• Cocoa extract placebo
Cocoa extract placebo
• Multivitamin placebo
Multivitamin placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Augusta University	Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Inflammaging	An index constructed using several inflammation markers reflecting inflammaging.	2 years
Secondary	Blood pressure	Systolic and diastolic blood pressure in mmHg.	2 years
Secondary	Body mass index	Body mass index in kg/m2 will be calculated using height and weight	2 years
Secondary	Pulse wave velocity	Pulse wave velocity in m/s from the carotid to the femoral artery will be measured.	2 years