Effects of Low or High Amounts of Dietary Protein and Resistance Training on Community-dwelling Older Adults: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Change from baseline in chair stand test (repetitions)
研究概览
简要总结
The aim of this randomized, observer-blind, controlled intervention study with parallel groups is to study the effect of resistance training (2x/week for 8 weeks) with and without different goals of protein intake on muscle strength, function and mass, oxidative stress parameters and the immune system in community dwelling persons.
Participants (n = 137) will be community-dwelling older adults. After a pre-participation screening participants will be distributed randomly but stratified by sex and age to one of the 3 groups (low protein + strength training, high protein + strength training, low protein and no strength training(=control)). Study participants are eligible if they are male or female with an age between 65 and 85 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate the training sessions, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, a frailty index at or above 3, medication with anticoagulants or cortisone drugs and also regular strength training during the last six months.
Primary outcome measure is the change in the Chair Stand Test. Secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters, microbiota, metabolomics, proteomics and the nutritional status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females between the age of 65 and 85 years of age
- •Adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (Mini-Mental-State >23)
- •Independently mobile
排除标准
- •Chronic diseases, which contraindicate a training participation
- •Serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias)
- •Diabetic retinopathy
- •Manifest osteoporosis
- •Regular use of cortisone-containing drugs
- •Regular strength training (> 1x / week) in the last 6 months before inclusion
研究组 & 干预措施
Strength Training and Protein high
6 weeks of high protein intake (additional 1g/kg bw/d) followed by a 8 weeks resistance training (Progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the protein intake remains.
干预措施: High protein intake (Other)
Strength Training and Protein high
6 weeks of high protein intake (additional 1g/kg bw/d) followed by a 8 weeks resistance training (Progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the protein intake remains.
干预措施: Strength training (Other)
Strength Training and Protein low
6 weeks of low protein intake (1g/kg bw/d) followed by a 8 weeks resistance training (Progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the protein intake remains.
干预措施: Low protein intake (Other)
Strength Training and Protein low
6 weeks of low protein intake (1g/kg bw/d) followed by a 8 weeks resistance training (Progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the protein intake remains.
干预措施: Strength training (Other)
Control
No Intervention.
干预措施: Control, no intervention (Other)
结局指标
主要结局
Change from baseline in chair stand test (repetitions)
时间窗: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
The maximum number of completed cycles of unsupported chair rises (from a seated to a fully erected position (hip and knees straightened)) completed within 30 s is counted.
次要结局
- Change from baseline in isometric quadriceps peak torque (Nm/kg)(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
- Change from baseline in handgrip strength (kg)(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
- Change from baseline in muscle mass with BIA (kg)(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
- Change from baseline in stool short-chain fatty acids (SCFAs)(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
- Change from baseline in inflammatory marker (i.g. IL-6, TNF-alpha)(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
- Change from baseline in 6min walking test (distance in meter)(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
- Change from baseline in the composition of gut-microbiota(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
- Change from baseline in oxidative stress marker such as malondialdehyd(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
- Change from baseline in the metabolomics response(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
- Change from baseline in the amino acid pattern(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
研究者
Karl-Heinz Wagner
Professor of Human Nutrition
University of Vienna