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

基本信息

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
项目类别：
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

项目摘要

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.

抽象的跌倒和身体机能随着年龄的增长而显着增加，并导致受伤、住院和需要安全、具有成本效益的一级预防策略来减少这些不良后果。基础、临床前和临床研究表明，美国人口老龄化中存在黄烷醇（一类营养素）。可可中高浓度的黄烷醇对肌肉和身体机能有良好的影响。减少氧化应激并改善线粒体生物发生和肌肉生长的生物标志物。研究表明补充可可黄烷醇对身体表现（包括握力）的潜在益处然而，目前还没有大型、长期的随机对照试验。（随机对照试验）补充黄烷醇对跌倒、肌肉性能和/或跌倒相关损伤的影响。可可补充剂和多种维生素结果研究 (COSMOS) 的辅助研究，该研究正在测试补充可可黄烷醇和/或多种维生素对预防心血管疾病和癌症，我们提出了第一项大型、安慰剂对照、前瞻性研究，以确定补充疗法是否有效黄烷醇可减少 65 岁以上女性和 60 岁以上男性的跌倒并改善肌肉骨骼健康。在拟议的研究中，我们将确定可可黄烷醇补充剂的效果 [600 毫克/天黄烷醇，包括 80 毫克 (-)-表儿茶素]和/或多种维生素对以下有临床意义的结果的影响：总体下降 COSMOS 队列 (n=21,444) 和诊所子队列 (n=603) 的身体表现我们将测试以下内容。假设：目标 1：在整个 COSMOS 队列中，补充可可黄烷醇将降低以下风险：(a) 受伤性跌倒导致前往医疗保健提供者或医院检查病历，并且 (b) 两次或每年更多的跌倒和 (c) 按年度评估的伤害性跌倒（未导致医疗保健利用）目标 2：在临床子队列中，补充可可黄烷醇将有益于身体健康。随机化后 2 年的表现测量，通过握力、步行速度和短距离进行评估身体表现电池（包括站立平衡、行走速度和椅子站立）。在整个 COSMOS 队列中，补充可可黄烷醇可减少骨折，评估结果如下：我们将探讨可可黄烷醇对骨折结果的影响是否是中介的。在探索性目标中，我们还将评估多种维生素对跌倒和/或骨密度变化的影响。这些相同的结果测试了多种维生素对跌倒和肌肉骨骼结果的影响。这项辅助研究最大限度地提高了成本效率，以填补有关黄烷醇影响的知识空白。我们希望拟议的严格转化研究能够阐明是否可以预防跌倒。补充黄烷醇可改善肌肉骨骼健康，防止跌倒和身体机能下降美国越来越多的老年人具有潜在的临床和公共卫生益处。