COcoa Supplement and Multivitamin Outcomes Study for the Mind
关键词
抽象
描述
Identifying a safe, affordable, and well-tolerated intervention that prevents cognitive decline in older adults is of critical public health importance. There is compelling evidence from basic science, and small clinical studies that cocoa flavanols may protect cognitive function in older adults and reduce risk of Alzheimer's disease (AD) and related dementia. Thus, this intervention could have important downstream benefits for health care utilization and cost, caregiver burden, and overall quality of life for older adults. Cocoa flavanol effects on cognition, however, need to be assessed in a definitive clinical trial.
The parent trial (COSMOS) will enroll 18,000 women and men nationwide, drawn from the Women's Health Initiative (WHI) participant cohort and the VITamin D and OmegA-3 TriaL (VITAL) non-randomized respondent cohort, and will be conducted primarily by mail to assess whether high-potency cocoa flavanol extract and a multivitamin - alone or in combination - will reduce risk of cardiovascular disease and cancer over 3 years of follow-up.
Once participants are enrolled in COSMOS, the study team at Brigham and Women's Hospital will provide contact information and other parent trial outcomes for COSMOS-Mind participants to the Wake Forest team using a secure web-based data transfer system. This seamless exchange of information between sites will permit timely accounting to ensure that the targeted demographics for enrollment are achieved (e.g. gender, age, race, ethnicity).
COSMOS-Mind will only be administered a telephone cognitive assessment to all participants at enrollment (baseline), and annually for 3 years of follow-up by trained and certified staff of the Wake Forest COSMOS-Mind team.
日期
最后验证: | 08/31/2019 |
首次提交: | 01/19/2017 |
提交的预估入学人数: | 01/24/2017 |
首次发布: | 01/26/2017 |
上次提交的更新: | 09/03/2019 |
最近更新发布: | 09/05/2019 |
实际学习开始日期: | 08/31/2016 |
预计主要完成日期: | 09/30/2020 |
预计完成日期: | 09/30/2020 |
状况或疾病
相
手臂组
臂 | 干预/治疗 |
---|---|
Cocoa extract + multivitamin 2 capsules containing 750 mg/d cocoa extract; daily MTV | |
Cocoa extract + multivitamin placebo 2 capsules containing 750 mg/d cocoa extract; daily MTV placebo | |
Cocoa extract placebo + multivitamin Cocoa extract placebo (2 capsules/d); daily MTV | |
Cocoa extract placebo + multivitamin placebo Cocoa extract placebo (2 capsules/d); daily MTV placebo |
资格标准
有资格学习的年龄 | 65 Years 至 65 Years |
有资格学习的性别 | All |
取样方式 | Non-Probability Sample |
接受健康志愿者 | 是 |
标准 | Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study: Inclusion Criteria - 1. Men and women 65 years and older. 2. Willingness to participate. 3. Ability to answer questions by phone. Exclusion Criteria - 1. Participants who are co-enrolled in the WHI Memory Study. 2. Participants with insulin-dependent diabetes. 3. Participants who are unable to complete the baseline cognitive assessments. |
结果
主要结果指标
1. Number of Participants that are not Hearing Impaired [4 years]
2. Cocoa extract effects on global cognitive trajectory [4 years]
次要成果指标
1. Multivitamin effects on global cognitive trajectory [4 years]
2. Treatment effects on incident cognitive impairment [4 years]
3. Intervention effects on executive function and episodic memory [4 years]