Centre for Active and Healthy Ageing, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark.
Department of Nutrition and Health, University College Copenhagen, Sigurdsgade 26, DK-2200, Copenhagen N, Denmark.
Trials. 2020 Jul 11;21(1):637. doi: 10.1186/s13063-020-04572-z.
The proportion of older citizens is increasing worldwide. A well-known syndrome in old age is physical frailty which is associated with a greater risk of disabilities in activities of daily living, greater reliance on in-home services, hospitalization, institutionalization, and premature mortality. The purpose of this study is to determine the effects of an intervention with high-protein diet alone or in combination with power training in pre-frail and frail old adults.
The study is a community-based assessor-blinded parallel randomized controlled trial (RCT), consisting of two phases. Phase 1 is a 1-month stabilization phase, where self-reliant community-dwelling adults + 80 years old will receive individual guidance regarding protein intake, to prevent the risk of negative protein balance prior to phase 2 and to only include participants who have reached the minimum recommended level of protein intake (1.0 g/kg/day) in the randomized controlled trial. Phase 2 is a 4-month RCT where 150 participants will be randomized into the following three arms: protein-only where participants will be provided with dairy products to increase their protein intake to 1.5 g/kg/day, protein + exercise where participants will be provided with the protein intervention in combination with power training two times a week, and recommendation group where participants will continue as in phase 1. Primary outcome is lower leg muscle power. Secondary outcomes include physical function and mobility, frailty status, muscle mechanical function, body composition, nutritional status, and health-related quality of life. The statistical analysis will include an intention-to-treat analysis of all randomized participant and per-protocol analysis of all compliant participants. The study hypothesis will be tested with mixed linear models to assess changes in the main outcomes over time and between study arms.
The finding of this study may add to the knowledge about the beneficial effects of high-protein diet from dairy products combined with power training to counteract frailty in community-dwelling older adults. This may ultimately have an impact on the ability to live well and independent for longer.
ClinicalTrials.gov NCT03842579 . Registered on 15 February 2019, version 1.
全球老年人口比例不断增加。老年人中一个众所周知的综合征是身体虚弱，这与日常生活活动能力残疾的风险增加、对家庭内服务、住院、机构化和过早死亡的更大依赖有关。本研究的目的是确定单独或联合进行高蛋白饮食和力量训练对虚弱和脆弱老年人的影响。
本研究是一项基于社区的评估者盲法平行随机对照试验（RCT），包括两个阶段。第一阶段是为期 1 个月的稳定阶段，在此期间，独立的社区居住的 80 岁以上成年人将接受关于蛋白质摄入的个体指导，以防止第二阶段前出现负蛋白质平衡的风险，并仅包括在随机对照试验中达到最低推荐蛋白质摄入量（1.0g/kg/天）的参与者。第二阶段是为期 4 个月的 RCT，将有 150 名参与者随机分为以下三个组：仅蛋白质组，为参与者提供乳制品以增加蛋白质摄入量至 1.5g/kg/天；蛋白质+运动组，为参与者提供蛋白质干预和每周两次的力量训练；推荐组，参与者继续在第一阶段。主要结局是小腿肌肉力量。次要结局包括身体功能和活动能力、虚弱状态、肌肉机械功能、身体成分、营养状况和健康相关生活质量。统计分析将包括对所有随机参与者的意向治疗分析和对所有符合条件的参与者的方案分析。研究假设将通过混合线性模型进行检验，以评估主要结局随时间和研究组的变化。
本研究的结果可能会增加关于从乳制品中获取高蛋白饮食联合力量训练对社区居住的老年人虚弱状态的有益效果的知识。这最终可能会对更长时间独立生活的能力产生影响。
ClinicalTrials.gov NCT03842579。于 2019 年 2 月 15 日注册，版本 1。
