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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cocoa extract + multivitamin | Active Comparator | Two capsules/day for 600 mg/day of cocoa flavanols One tablet/day of multivitamin |
|
| Cocoa extract + multivitamin placebo | Active Comparator | Two capsules/day for 600 mg/day of cocoa flavanols Multivitamin placebo |
|
| Cocoa extract placebo + multivitamin | Active Comparator | Cocoa extract placebo One tablet/day of multivitamin |
|
| Cocoa extract placebo + multivitamin placebo | Placebo Comparator | Cocoa extract placebo Multivitamin placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cocoa extract | Dietary Supplement | 2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine |
|
| 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 |
| 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 |
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Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study:
Inclusion Criteria:
Exclusion Criteria:
• Did not collect blood samples at baseline, Year 1, or Year 2 of follow-up.
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069956 | Chocolate |
| C067316 | Geritol |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Multivitamin | Dietary Supplement | Multivitamin |
|
| Cocoa extract placebo | Dietary Supplement | Cocoa extract placebo |
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| Multivitamin placebo | Dietary Supplement | Multivitamin placebo |
|
| 2 years |
| Pulse wave velocity | Pulse wave velocity in m/s from the carotid to the femoral artery will be measured. | 2 years |