COcoa Supplement and Multivitamin Outcomes Study (COSMOS): Effects on Falls and Physical Performance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 21,442
- 试验地点
- 1
- 主要终点
- Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital)
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 improve musculoskeletal health and prevent falls and declining physical performance in the increasing number of older adults in the U.S. with potential for clinical and public health benefits.
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:
- •Participants who reported an injurious fall resulting in healthcare utilization (visit to a healthcare provider or hospital)
- •Participants who reported recurrent falls (2 or more falls per year)
排除标准
- 未提供
研究组 & 干预措施
Cocoa extract + multivitamin
干预措施: Multivitamin (Dietary Supplement)
Cocoa extract + multivitamin placebo
干预措施: Multivitamin placebo (Dietary Supplement)
Cocoa extract placebo + multivitamin
干预措施: Cocoa extract placebo (Dietary Supplement)
Cocoa extract placebo + multivitamin
干预措施: Multivitamin (Dietary Supplement)
Cocoa extract placebo + multivitamin placebo
干预措施: Cocoa extract placebo (Dietary Supplement)
Cocoa extract placebo + multivitamin placebo
干预措施: Multivitamin placebo (Dietary Supplement)
Cocoa extract + multivitamin
干预措施: Cocoa extract (Dietary Supplement)
Cocoa extract + multivitamin placebo
干预措施: Cocoa extract (Dietary Supplement)
结局指标
主要结局
Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital)
时间窗: 5 years
Recurrent falls (2 or more falls per year)
时间窗: 5 years
次要结局
未报告次要终点
研究者
Meryl LeBoff
Principal Investigator
Brigham and Women's Hospital