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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
21,442
2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
Multivitamin
Cocoa extract placebo
Multivitamin placebo
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.
Time frame: 2 years
Inflammaging
An index constructed using several inflammation markers reflecting inflammaging.
Time frame: 2 years
Blood pressure
Systolic and diastolic blood pressure in mmHg.
Time frame: 2 years
Body mass index
Body mass index in kg/m2 will be calculated using height and weight
Time frame: 2 years
Pulse wave velocity
Pulse wave velocity in m/s from the carotid to the femoral artery will be measured.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.