Effect of Randomized Cocoa Supplementation on Inflammaging and Epigenetic Aging
试验速览
- 阶段
- 4 期
- 入组人数
- 21,442
- 主要终点
- Epigenetic age acceleration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Did not collect blood samples at baseline, Year 1, or Year 2 of follow-up.
研究组 & 干预措施
Cocoa extract + multivitamin
Two capsules/day for 600 mg/day of cocoa flavanols One tablet/day of multivitamin
干预措施: Multivitamin (Dietary Supplement)
Cocoa extract + multivitamin placebo
Two capsules/day for 600 mg/day of cocoa flavanols Multivitamin placebo
干预措施: Multivitamin placebo (Dietary Supplement)
Cocoa extract placebo + multivitamin
Cocoa extract placebo One tablet/day of multivitamin
干预措施: Multivitamin (Dietary Supplement)
Cocoa extract placebo + multivitamin
Cocoa extract placebo One tablet/day of multivitamin
干预措施: Cocoa extract placebo (Dietary Supplement)
Cocoa extract placebo + multivitamin placebo
Cocoa extract placebo Multivitamin placebo
干预措施: Cocoa extract placebo (Dietary Supplement)
Cocoa extract placebo + multivitamin placebo
Cocoa extract placebo Multivitamin placebo
干预措施: Multivitamin placebo (Dietary Supplement)
Cocoa extract + multivitamin
Two capsules/day for 600 mg/day of cocoa flavanols One tablet/day of multivitamin
干预措施: Cocoa extract (Dietary Supplement)
Cocoa extract + multivitamin placebo
Two capsules/day for 600 mg/day of cocoa flavanols Multivitamin placebo
干预措施: Cocoa extract (Dietary Supplement)
结局指标
主要结局
Epigenetic age acceleration
时间窗: 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
时间窗: 2 years
An index constructed using several inflammation markers reflecting inflammaging.
次要结局
- Pulse wave velocity(2 years)
- Body mass index(2 years)
- Blood pressure(2 years)