Different Protein and Derivatives Supplementation Strategies Combined With Resistance Training in Pre-frail and Frail Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- muscle function
研究概览
简要总结
Resistance training combined with protein or amino acids supplementation has been shown to be promising for mitigating age-related disabilities and comorbidities. Randomized controlled trials supporting this possibility are still scarce. These series of clinical trials aim to investigate the chronic effects of different strategies of protein and derivatives supplementation in association with resistance training on selected health-related parameters in pre-frail and frail elderly.This is a 16-month, double-blind, randomized, placebo-controlled, parallel-group clinical trial involving a series of investigations. Participants will be divided into nine groups, allowing the assessement of the effects of (1) isolated leucine supplementation; (2) protein source (whey vs. soy); (3) combination of whey protein and creatine; and (4) sexual dimorphism to the response of protein intake plus resistance training (men vs. women). All participants will undergo a supervised, resistance training program.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elderly people
- •frailty or pre-frailty, according to Fried et al., (2001) criteria.
排除标准
- •on exogenous insulin and steroid-based drugs
- •chronic obstructive pulmonary disease or respiratory failure
- •use of protein and /or amine-based dietary supplements
- •on restrictive diets (e.g. calorie or food group restrictions)
- •on resistance training
- •untreated cardiovascular, metabolic, or other chronic disease
- •any musculoskeletal condition precluding resistance training
结局指标
主要结局
muscle function
时间窗: 4 months
assessed by a battery of physical tests
lean mass
时间窗: 4 months
assessed by Dual-energy X-ray absorptiometry
次要结局
- insulin sensitivity(4 months)
- health related-quality of life(4 months)
- bone mass(4 months)
研究者
Bruno Gualano
Professor
University of Sao Paulo
