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临床试验/NCT00874575
NCT00874575已完成1 期

A Double Blind Study on the Efficacy of a Combination of Beta-hydroxy-beta-methylbutyrate and Vitamin D on Muscular Strength and Functionality in Older Adults.

Metabolic Technologies Inc.2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
76
试验地点
2
主要终点
Muscular Strength and functionality

研究概览

简要总结

The purpose of the study is to

  • Test the effect of a dietary supplement beta-hydroxy-beta-methylbutyrate (HMB) with and without Vitamin D to prevent and reverse the losses of muscular strength and functionality in older adults.

The second aim of the study is to determine if HMB and Vitamin D improves markers of bone turnover in adults aged 60 plus years. HMB is a dietary supplement that comes from the amino acid leucine. HMB is found in foods and is made in your body after you eat protein (meat). Subjects will be randomized to one of four dietary supplement groups and will participate in a 3-day per week exercise program for 12 weeks. Each exercise day will be about 60 minutes long consisting of strength training exercises utilizing Theraband® stretch cords and jumping.

Subjects will consume the dietary supplement 2 times per day for 12 weeks. Tests will consist of the following:

  • Measuring the strength of subjects' legs by using a Isokinetic Dynamometer
  • Measuring body composition
  • Measuring hand-grip strength using a hand-grip dynamometer
  • Measuring functional mobility, balance and agility by the time it takes for you to rise from a chair, walk around a cone 8 feet in front of the chair and return to the chair (Up-&-Go Test
  • Filling out questionnaires and having blood drawn for biochemical measurements. Testing will be performed at the beginning and at 4, 8 and 12 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

1

Placebo Comparator

Control

干预措施: Placebo (Dietary Supplement)

2

Experimental

Beta-hydroxy-Beta-methylbutyrate, 3 g/d

干预措施: Beta-hydroxy-Beta-methylbutyrate (Dietary Supplement)

3

Experimental

Vitamin D, 2000 IU/d

干预措施: Vitamin D (Dietary Supplement)

4

Experimental

Beta-hydroxy-Beta-methylbutyrate (3 g/d) + Vitamin D (2000 IU/d)

干预措施: Beta-hydroxy-Beta-methylbutyrate and Vitamin D (Drug)

结局指标

主要结局

Muscular Strength and functionality

时间窗: 12 weeks

次要结局

  • Bone turnover(12 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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