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

可可补充剂和多种维生素结果研究 (COSMOS)：对跌倒和身体表现的影响

• 批准号: 10576403
• 负责人: CAROLYN JANET CRANDALL
• 金额: $ 67.69万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-15 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10576403
• 关键词: Adult; Age; Aging; Ancillary Study; Attention; Beverages; Biogenesis; Biological Markers; Blood specimen; Body Composition; Body mass index; Bone Density; Boston; Cardiovascular Diseases; Center for Translational Science Activities; Cessation of life; Clinic; Clinical; Clinical Research; Clinical Sciences; Cocoa Powder; Cohort Studies; Cost efficiency; Data; Double-Blind Method; Elderly; Equilibrium; Ethnic Origin; Exercise; Fall prevention; Flavanol; Forearm Fracture; Fracture; Growth; Hand Strength; Health; Health Benefit; Health Personnel; Hip Fractures; Hospitalization; Hospitals; Injury; Intervention; Knowledge; Literature; Location; Malignant Neoplasms; Measurement; Measures; Mediating; Medical; Medical Records; Mitochondria; Modification; Multivitamin; Muscle; Muscle function; Musculoskeletal; Nutrient; Outcome; Outcome Study; Oxidative Stress; Participant; Performance; Peripheral arterial disease; Phenotype; Physical Function; Physical Performance; Physical assessment; Physicians; Placebo Control; Placebos; Population; Prevention strategy; Primary Prevention; Prospective Studies; Public Health; Questionnaires; Race; Randomized; Randomized, Controlled Trials; Recovery; Recurrence; Reporting; Resources; Risk; Risk Reduction; Source; Spinal Fractures; Supplementation; Testing; Thinness; United States National Institutes of Health; Visit; Water; Woman; adjudication; adverse outcome; age related; aged; bone; cancer risk; cardiovascular disorder prevention; cohort; cost; cost effective; cost efficient; design; epicatechin; fall injury; falls; follow-up; health care service utilization; human old age (65+); improved; men; meter; muscle strength; older men; older women; preclinical study; primary outcome; sex; translational study; walking speed; wrist fracture; young adult; Adult; Age; Aging; Ancillary Study; Attention; Beverages; Biogenesis; Biological Markers; Blood specimen; Body Composition; Body mass index; Bone Density; Boston; Cardiovascular Diseases; Center for Translational Science Activities; Cessation of life; Clinic; Clinical; Clinical Research; Clinical Sciences; Cocoa Powder; Cohort Studies; Cost efficiency; Data; Double-Blind Method; Elderly; Equilibrium; Ethnic Origin; Exercise; Fall prevention; Flavanol; Forearm Fracture; Fracture; Growth; Hand Strength; Health; Health Benefit; Health Personnel; Hip Fractures; Hospitalization; Hospitals; Injury; Intervention; Knowledge; Literature; Location; Malignant Neoplasms; Measurement; Measures; Mediating; Medical; Medical Records; Mitochondria; Modification; Multivitamin; Muscle; Muscle function; Musculoskeletal; Nutrient; Outcome; Outcome Study; Oxidative Stress; Participant; Performance; Peripheral arterial disease; Phenotype; Physical Function; Physical Performance; Physical assessment; Physicians; Placebo Control; Placebos; Population; Prevention strategy; Primary Prevention; Prospective Studies; Public Health; Questionnaires; Race; Randomized; Randomized, Controlled Trials; Recovery; Recurrence; Reporting; Resources; Risk; Risk Reduction; Source; Spinal Fractures; Supplementation; Testing; Thinness; United States National Institutes of Health; Visit; Water; Woman; adjudication; adverse outcome; age related; aged; bone; cancer risk; cardiovascular disorder prevention; cohort; cost; cost effective; cost efficient; design; epicatechin; fall injury; falls; follow-up; health care service utilization; human old age (65+); improved; men; meter; muscle strength; older men; older women; preclinical study; primary outcome; sex; translational study; walking speed; wrist fracture; young adult

ABSTRACT Falls and decreased physical function increase markedly with age and result in injury, hospitalization, and death. Safe, cost-effective primary prevention strategies are needed to reduce these adverse outcomes in the aging U.S. population. Basic, preclinical, and clinical studies suggest that flavanols, a class of nutrients present in high concentrations in cocoa, have favorable effects on muscle and physical performance. Flavanols decrease oxidative stress and improve biomarkers of mitochondrial biogenesis and muscle growth. Emerging studies show potential benefits of supplemental cocoa flavanols on physical performance, including grip strength and walking speed in older adults. However, there are no large, long-term randomized controlled trials (RCTs) of the effects of supplemental flavanols on falls, muscle performance, and/or fall-related injuries. In an ancillary study to the COcoa Supplement and Multivitamins Outcomes Study (COSMOS), which is testing the effects of supplemental cocoa flavanols and/or multivitamin for the prevention of cardiovascular disease and cancer, we propose the first large, placebo-controlled, prospective study to determine whether supplemental flavanols reduce falls and improve musculoskeletal health in women aged ≥ 65 and men aged ≥ 60. In the proposed study, we will determine effects of a cocoa flavanol supplement [600 mg/d flavanols, including 80 mg (-)- epicatechins] and/or multivitamin on the following clinically meaningful outcomes: falls in the overall COSMOS cohort (n=21,444) and physical performance in a clinic sub-cohort (n=603). We will test the following hypotheses: Aim 1: In the overall COSMOS cohort, cocoa flavanol supplementation will reduce risk of: (a) injurious fall(s) resulting in a visit to a healthcare provider or hospital with medical record review and (b) two or more falls per year and (c) injurious fall(s) (not resulting in healthcare utilization) as assessed by annual questionnaires. Aim 2: In the clinic sub-cohort, cocoa flavanol supplementation will benefit physical performance measures at 2-year post randomization, as assessed by grip strength, walking speed, and Short Physical Performance Battery (a composite of standing balance, walking speed, and chair stands). Aim 3: In the overall COSMOS cohort, cocoa flavanol supplementation reduces incident fractures as assessed by annual questionnaires. We will explore whether effects of cocoa flavanols on fracture outcomes are mediated through falls and/or bone density changes. In exploratory aims we will also assess effects of multivitamins on these same outcomes. RCTs testing effects of multivitamins on falls and musculoskeletal outcomes are lacking. This ancillary study maximizes cost-efficiency to fill gaps in knowledge regarding effects of flavanols for the primary prevention of falls. We expect the proposed, rigorous translational study will elucidate whether supplemental flavanols 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.

抽象的 随着年龄的增长，跌倒和身体功能的改善明显增加，并导致受伤，住院和 死亡。需要安全，具有成本效益的初级预防策略来减少这些不利结果 美国老年人口。基本，临床前和临床研究表明，黄酮醇，一类营养物质 在可可中的高浓度中，对肌肉和身体性能产生了有利的影响。黄烷醇 减少了线粒体生物发生和肌肉生长的氧化应激和改善的生物标志物。新兴 研究表明，补充可可黄烷醇对身体表现的潜在好处，包括握把 老年人的力量和步行速度。但是，没有大型的长期随机对照试验 （RCT）补充黄酮醇对瀑布，肌肉表现和/或与跌倒有关的损伤的影响。在 可可补充剂和多种维生素结果研究（COSMOS）的辅助研究，正在测试 补充可可黄烷醇和/或多种维生素的影响预防心血管疾病和 癌症，我们提出了第一个大型，安慰剂对照的前瞻性研究，以确定是否补充 黄烷醇减少跌落并改善≥65岁的女性和≥60岁的男性的肌肉骨骼健康。 拟议的研究，我们将确定可可黄烷醇补充剂的影响[600 mg/d黄烷醇，包括80 mg （ - ） - Epimatechins]和/或多种维生素在以下临床上有意义的结果：落在总体上 cosmos队列（n = 21,444）和诊所亚科岛的身体表现（n = 603）。我们将测试以下 假设：目标1：在整个宇宙队列中，可可黄烷醇补充剂将降低：（a） 造成病历审查的医疗保健提供者或医院的造成伤害跌倒，以及（b）两个或 每年更多的跌倒和（c）受伤的秋季（未导致医疗保健利用），如年度评估 问卷。 AIM 2：在诊所亚科奥特，可可黄烷醇补充剂将使物理受益 通过抓地力，步行速度和短时 身体性能电池（站立平衡，步行速度和椅子支架的综合）。目标3：在 总体宇宙队列的可可黄烷醇补充剂减少了被评估的入射骨折 年度问卷。我们将探讨可可黄烷醇对裂缝结果的影响是否介导 通过跌落和/或骨密度变化。在探索目的中，我们还将评估多种维生素对 这些相同的结果。多种维生素对瀑布和肌肉骨骼结局的RCT测试影响是 缺乏。这项辅助研究最大化成本效益，以填补有关黄酮醇影响的知识的空白 主要预防跌倒。我们预计提出的严格翻译研究将阐明 补充黄酮醇可改善肌肉骨骼健康，防止跌倒并下降 美国老年人的越来越多，具有临床和公共卫生益处的潜力。