跳至主要内容
临床试验/NCT05232669
NCT05232669进行中(未招募)不适用

COcoa Supplement and Multivitamin Outcomes Study (COSMOS): Effects on Falls and Physical Performance

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 21,442 人开始时间: 2021年5月15日最近更新:
适应症
干预措施

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

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

Active Comparator

干预措施: Multivitamin (Dietary Supplement)

Cocoa extract + multivitamin placebo

Active Comparator

干预措施: Multivitamin placebo (Dietary Supplement)

Cocoa extract placebo + multivitamin

Active Comparator

干预措施: Cocoa extract placebo (Dietary Supplement)

Cocoa extract placebo + multivitamin

Active Comparator

干预措施: Multivitamin (Dietary Supplement)

Cocoa extract placebo + multivitamin placebo

Placebo Comparator

干预措施: Cocoa extract placebo (Dietary Supplement)

Cocoa extract placebo + multivitamin placebo

Placebo Comparator

干预措施: Multivitamin placebo (Dietary Supplement)

Cocoa extract + multivitamin

Active Comparator

干预措施: Cocoa extract (Dietary Supplement)

Cocoa extract + multivitamin placebo

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meryl LeBoff

Principal Investigator

Brigham and Women's Hospital

研究点 (1)

Loading locations...

相似试验