Aging, Cardiovascular Diseases, Inflammation
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCocoa extract
2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
DIETARY_SUPPLEMENTMultivitamin
Multivitamin
DIETARY_SUPPLEMENTCocoa extract placebo
Cocoa extract placebo
DIETARY_SUPPLEMENTMultivitamin placebo
Multivitamin placebo
Sponsors
Brigham and Women's Hospital
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Inflammaging | 2 years | An index constructed using several inflammation markers reflecting inflammaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 2 years | Systolic and diastolic blood pressure in mmHg. |
| Body mass index | 2 years | Body mass index in kg/m2 will be calculated using height and weight |
| Pulse wave velocity | 2 years | Pulse wave velocity in m/s from the carotid to the femoral artery will be measured. |
Outcome results
None listed