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临床试验/NCT01890382
NCT01890382已完成不适用

Different Protein and Derivatives Supplementation Strategies Combined With Resistance Training in Pre-frail and Frail Elderly

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年10月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruno Gualano

Professor

University of Sao Paulo

研究点 (2)

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