Nutritional Intervention for Age-Related Muscular Function and Strength Losses

针对与年龄相关的肌肉功能和力量损失的营养干预

基本信息

批准号：
8775460
负责人：
John A Rathmacher
金额：
$ 37.5万
依托单位：
METABOLIC TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-07-01 至 2017-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8775460
关键词：
Adult Affect Age Aging American Amino Acids Arthritis Back Biochemical Biopsy Body Composition Bone Density Bone callus Bone remodeling Bunion Calcium Caliber Censuses Centers for Disease Control and Prevention (U.S.)Cholecalciferol Climate Communicable Diseases Data Data Analyses Deformity Diet Dietary Intervention Disease Economics Effectiveness Elderly Elderly man Elderly woman Equilibrium Exercise Experimental Designs Fall prevention Fast-Twitch Muscle Fibers Fiber Flexor Fracture Functional disorder Future Gait General Population Health Incidence Individual Injury Investigation Joint Instability Knee Knowledge Laboratories Labyrinth Lead Legal patent Life Literature Longitudinal Studies Marketing Measurement Measures Metabolic Morbidity - disease rate Muscle Muscle Fibers Muscle function Musculoskeletal Nutrient Older Population Pharmaceutical Preparations Phase Phase I Clinical Trials Plasma Pneumonia Population Probability Prospective Studies Proteomics Public Health Publishing Quality of life Recruitment Activity Relative (related person)Reporting Research Risk Risk Factors Sodium Chloride Somatotype Structure of nail of toe Sum Supplementation Techniques Testing Time Time Study Toes Training Translating United States Vision Vitamin D Vitamin D Deficiency Vitamin D2 Woman age related aging population arginyllysine arm base bone bone turnover clinically significant combat disorder prevention economic cost fall risk falls foot grasp improved men metabolic abnormality assessment muscle aging muscle form muscle metabolism muscle strength phase 1 study phase 2 study prevent programs prospective protein degradation sarcopenia screening sports related nutrition wasting

项目摘要

DESCRIPTION (provided by applicant): Sarcopenia, defined as age related loss of muscle mass and muscle function and strength, is very prevalent among the elderly. Sarcopenia is one of the largest public health problems facing a rapidly increasing, aging population in the United States and leads to increased incidence of falls, fractures and associated morbidities. Previous observations from our laboratory, as well as from many other laboratories, have demonstrated the efficacy of 2-hydroxy-2-methylbutyrate (HMB) alone or in combination with other amino acids in enhancing muscle strength and function in young athletes. We have recently demonstrated that the combination of HMB with two other amino acids, arginine and lysine, was effective in increasing muscle mass in elderly men and women during a year-long prospective study. When analyzing the data (Preliminary Results), we demonstrated a close correlation between the levels of 25-OH Vitamin D3 in this population and the level of improvement in muscle strength. We noted that individuals with plasma 25-OH Vitamin D3 levels >30 ng/ml manifested muscle strength gains supplemented with HMB and two amino acids, while those with plasma 25- OH Vitamin D3 of <30 ng/ml did not. These data form the basis of our current hypothesis that the combination of HMB and Vitamin D supplementation will be synergistic and will result in significant enhancements in overall muscle strength, function and muscle mass. We propose these Phase I and Phase II studies to prove our hypothesis. The Phase I study will test the short-term (12-wk) efficacy of a combination of HMB and Vitamin D to prevent and reverse muscle sarcopenia and the associated losses of muscular strength and functionality in older adults. We plan to recruit 100 men and women who will be assigned to one of four dietary treatments: (1) Control; (2) HMB (calcium salt), 3.0 g/day; (3) 2,000 IU Vitamin D; and (4) HMB, 3.0 g/d + 2,000 IU Vitamin D. The subjects will undergo a 3-day per week exercise program, and body composition and strength will be measured at four week intervals. We expect to demonstrate the synergy between HMB and Vitamin D in this short study. Phase II will test the long-term (12-mos) efficacy of this synergistic combination of HMB and Vitamin D on the enhancement of muscle strength and functionality in the elderly, thus leading to improved quality of life. Phase II will include an exercise arm just like Phase I, but will also include a non-exercise arm because many elderly adults do not participate in an exercise program. In addition to body composition and function and strength data, muscle biopsies will be obtained and muscle fiber and proteomic analysis will be performed. We anticipate that the data generated will lead to further research looking at mechanism(s) involved in loss of muscle and muscle function in the elderly. Improvement in muscle strength and muscle function as well as improvements in body composition over the year-long study will be used to market a product containing HMB and Vitamin D.

描述（由申请人提供）：肌肉减少症，被定义为年龄相关的肌肉质量和肌肉功能和力量，在老年中非常普遍。肌肉减少症是美国面临的最大公共卫生问题之一，在美国迅速增加，人口老龄化，导致跌倒，裂缝和相关病态的发病率增加。我们实验室以及许多其他实验室的先前观察结果表明，仅2-羟基-2-甲基丁酸（HMB）或与其他氨基酸联合起来增强年轻运动员的肌肉力量和功能的功效。我们最近证明，在为期一年的前瞻性研究中，HMB与其他两种氨基酸（精氨酸和赖氨酸）的组合有效地增加了老年男性和女性的肌肉质量。在分析数据（初步结果）时，我们证明了该人群中25-OH维生素D3的水平与肌肉强度改善水平之间的相关性。我们注意到，血浆25-OH维生素D3水平> 30 ng/ml表现出补充了HMB和两个氨基酸的肌肉强度增长，而血浆25- OH维生素D3的肌肉力量<30 ng/ml。这些数据构成了我们目前假设的基础，即补充HMB和维生素D的组合将是协同作用，并将导致整体肌肉强度，功能和肌肉质量的显着增强。我们提出了这些第I期和II期研究，以证明我们的假设。第一阶段的研究将测试HMB和维生素D组合的短期（12周）功效，以预防和逆转肌肉肌肉减少症以及老年人肌肉力量和功能的相关损失。我们计划招募100名男女，他们将被分配到四种饮食疗法之一：（1）控制；（2）HMB（钙盐），3.0 g/天；（3）2,000 IU维生素D；（4）HMB，3.0 g/d + 2,000 IU维生素D。受试者将进行每周3天的运动计划，身体成分和强度将以四周的间隔进行测量。我们希望在这项简短的研究中证明HMB和维生素D之间的协同作用。第二阶段将测试HMB和维生素D这种协同组合对增强老年人肌肉强度和功能的长期（12-MOS）功效，从而导致生活质量的改善。第二阶段将包括像第一阶段一样的运动臂，但还将包括一个非运动臂，因为许多老年人不参加运动计划。除了身体组成，功能和力量数据外，还将获得肌肉活检，并将进行肌肉纤维和蛋白质组学分析。我们预计产生的数据将导致进一步研究，研究老年人肌肉和肌肉功能涉及的机制。在为期一年的研究中，肌肉力量和肌肉功能的改善以及身体成分的改善将用于销售含有HMB和维生素D的产品。