Cocoa Supplement and Multivitamin Outcomes Study in the Mind (COSMOS-Mind)

可可补充剂和多种维生素的心理结果研究 (COSMOS-Mind)

• 批准号: 9103266
• 负责人: Laura D. Baker
• 金额: $ 80.65万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-01 至 2021-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9103266
• 关键词: Adult; Affect; Age; Age-Years; Alzheimer' s Disease; Alzheimer' s disease risk; Ancillary Study; Animals; Anti-Inflammatory Agents; Anti-inflammatory; Antioxidants; Attenuated; Basic Science; Blood Vessels; Blood flow; Body mass index; Brain; Cardiovascular Diseases; Caregiver Burden; Cerebrovascular Disorders; Certification; Chocolate; Clinical Research; Clinical Trials; Cocoa Powder; Cognition; Cognitive; Collection; Consumption; Controlled Clinical Trials; Data; Data Quality; Dementia; Diabetes Mellitus; Double-Blind Method; Elderly; Enrollment; Ensure; Epidemiologic Studies; Flavanol; Flavonoids; Funding; Genes; Health; Health Sciences; Hippocampus (Brain); Impaired cognition; Incidence; Insulin; Intake; Intervention; Investigation; Language; Leadership; Learning; Legal patent; Letters; Link; Long-Term Potentiation; Malignant Neoplasms; Measures; Mediating; Memory; Mind; Multivitamin; National Heart, Lung, and Blood Institute; Neurons; Nutrient; Nutritional; Omega-3 Fatty Acids; Outcome; Outcome Study; Parents; Participant; Placebo Control; Placebos; Planet Mars; Process; Protocols documentation; Public Health; Quality of life; Randomized; Recruitment Activity; Research Design; Resources; Respondent; Risk; Risk Factors; Sampling; Short-Term Memory; Signal Pathway; Silver; Sleep; Source; Subgroup; Supplementation; Synaptic Membranes; Synaptic plasticity; System; Techniques; Telephone; Testing; Theobromine; Time; Uncontrolled Study; Universities; Up-Regulation; Vasodilation; Vitamin D; Woman; Women' s Health; adjudication; aged; bean; blood perfusion; brain health; cancer risk; capsule; cardiovascular disorder risk; cardiovascular health; cognitive function; cognitive testing; cohort; control trial; cost; cost effective; cost efficient; data management; data sharing; depressive symptoms; epicatechin; executive function; experience; follow-up; forest; health care service utilization; health related quality of life; high risk; human old age (65+); intervention effect; men; mild cognitive impairment; neuroregulation; normal aging; novel; pathological aging; prevent; protective effect; public health relevance; randomized placebo controlled trial; sex; treatment effect; treatment response

 DESCRIPTION (provided by applicant): Identifying a safe, affordable, and well-tolerated intervention that prevents cognitive decline in older adults is of critical public health importanc. 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. We propose to leverage the unique and timely opportunity provided by the funded COcoa Supplement and Multivitamin Outcomes Study (COSMOS) to conduct an ancillary cognitive study, referred to as "COSMOS-Mind." COSMOS is a randomized, double-blind, placebo-controlled clinical trial that will begin randomization in early 2016. It 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. COSMOS will assess whether high-potency cocoa flavanol extract (capsules containing 750 mg/d flavanols, including 75 mg (-)-epicatechin, and 90 mg theobromine; Mars Symbioscience) and a multivitamin (Pfizer Centrum(r) Silver(r)) - alone or in combination - will reduce risk of cardiovascular disease and cancer over 4 years of follow-up. The COSMOS leadership invited us to conduct an ancillary study to examine the cognitive effects of their interventions, given our extensive and successful experience collecting cognitive data using cost-effective and validated telephone-administered assessments in the geographically diverse WHI cohort. COSMOS-Mind will enroll 2,000 participants from COSMOS (50% men, aged ≥65 years), and conduct standardized telephone cognitive assessments pre-randomization and annually for 3 years to examine longitudinal effects of cocoa flavanols on a cognitive composite outcome. We will also establish whether administration of a multivitamin benefits cognition, explore whether cocoa flavanols reduce risk of dementia including AD, and examine intervention effects on key cognitive domains (e.g., executive function, short-term memory). Our assessments will yield reliable and sensitive measures of memory, executive function, language, and global cognitive function. We will use our previously successful techniques to promote high retention and longitudinal reliability. Our proposed cohort will provide >90% statistical power to establish whether cocoa flavanols protect cognitive function. We will share our data with the COSMOS study groups, WHI, and VITAL to facilitate other investigations and expand the scientific footprint of our study. COSMOS-Mind is an unprecedented, cost- efficient, and timely opportunity to test whether cocoa flavanols - a promising and widely translatable intervention - can protect against normal and pathological cognitive decline.

 描述（由适用提供）：确定一种安全，负担得起且耐受性良好的干预措施，以防止老年人认知能力下降至关重要。有来自基础科学的令人信服的证据，小型临床研究表明可可黄烷醇可以保护老年人的认知功能，并降低阿尔茨海默氏病（AD）和相关痴呆症的风险。这是，这种干预措施可能会为医疗保健利用和成本，看护人伯恩（Caregiver Burnen）以及老年人的整体生活质量带来重要的下游益处。但是，需要在确定的临床试验中评估可可黄烷醇对认知的影响。我们建议利用资助的可可补充剂和多种维生素结果研究（COSMOS）提供的独特和及时的机会，以进行一项辅助认知研究，称为“ Cosmos-Mind”。 Cosmos是一项随机，双盲，安慰剂对照的临床试验，将于2016年初开始随机分配。它将在全国范围内注册18,000名男性和男性，是根据女性健康计划（WHI）参与者的同伙和维生素D和维生素D和Omega-3和Omega-3试验（重要）非偶然受访者COHORT的主导，并以邮寄为单位。 COSMOS will assess whether high-potency cocoa flavanol extract (capsules containing 750 mg/d flavanols, including 75 mg (-)-epicatechin, and 90 mg theobromine; Mars Symbioscience) and a multivitamin (Pfizer Centrum(r) Silver(r)) - alone or in combination - will reduce risk of cardiovascular disease and cancer over 4 years of后续。宇宙领导层邀请我们进行一项辅助研究，以研究其干预措施的认知效果，因为我们通过在地球上差异的经济有效且经过验证的电话管理评估来收集认知数据的丰富经验。 Cosmos-Mind将招募来自Cosmos的2,000名参与者（50％的男性，年龄≥65岁），并预先进行随机化进行标准化的电话认知评估，并每年3年以检查可可黄烷醇对认知复合材料结果的纵向影响。我们还将确定对多种维生素的施用是否有益认知，探索可可黄烷醇是否会降低包括AD在内的痴呆症的风险以及对关键认知领域（例如执行功能，短期记忆）的影响。我们的评估将产生可靠和敏感的记忆，执行功能，语言和全球认知功能。我们将使用以前成功的技术来促进高保留率和纵向可靠性。我们提出的队列将提供> 90％的统计能力，以确定可可黄烷醇是否保护认知功能。我们将与宇宙研究小组（WHI）共享我们的数据，以促进其他研究并扩大我们研究的科学足迹。 Cosmos -Mind是一个前所未有的，具有成本效益和及时的机会，可以测试可可黄烷醇（一种有望且可转换的干预）是否可以预防正常和病理认知能力下降。