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临床试验/NCT01900548
NCT01900548已完成不适用

Effect of Intake of Protein High in Ketogenic Amino Acids (e.g. Leucine) in Elderly Osteopenic Patients. Implications for Muscle, Bone , Metabolism, and Physical Function.

University of Aarhus2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
2
主要终点
4 meter gait speed

研究概览

简要总结

The aim of this study is to investigate potential metabolic effects of whey protein high in protein and high in leucine(HPHL) compared to soy protein high in protein and low in leucine(HPLL) in osteopenic patients in a randomized controlled intervention study.

The investigator hypothesize that HPHL will increase physical function and the ratio muscle mass / fat mass in this condition.

详细描述

With an increase in the older population in Denmark and most other countries there is an increase in the rate of patients with age related bone and muscle weakness. Proteins with a high content in ketogenic amino acids e.g. leucine have been investigated in relation to these conditions. Generally acute studies in animals and some in human have been conducted and have demonstrated positive effects in relation to prevention and treatment of bone and muscle weakness. We want to investigate these tendencies with supplementation of proteins in a randomized, blinded, 4 month intervention study with three arms - 1) the control group. 2) soy protein(high protein, low leucine). 3) Whey protein(high protein, high leucine). To increase any possible effect of the supplementation the subjects will complete a resistance training program concurrently. The study will focus on the anabolic properties of the ketogenic amino acids in animal whey protein compared to vegetable soy protein.

The investigator will study changes in:

  • Gait speed related to muscle strength
  • Walk distance in a Six-minute walk test related to sub maximal physical capacity
  • Body composition (LBM/FM ratio) by a DEXA-scanner
  • Biochemical markers on bone metabolism
  • Bone-mineral-density(BMD) and -content(BMC)(DEXA scans)
  • Muscle strength
  • Body balance
  • Protein and amino acid balance
  • Nitrogen balance
  • Gene-expression in muscle tissue
  • Biochemical markers on fat- sugar- and protein-metabolism
  • Biochemical markers on inflammation
  • Blood pressure
  • Insulin sensitivity by HOMA index
  • Estimated maximal physical capacity by a bicycle ergometer test.

The perspective in this study is to develop a nutritional supplement with a high content of ketogenic amino acids (e.g. Leucine) that can be useful and beneficial in treatment and prevention of patients with bone and muscle weakness.

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 (Participant)

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Osteopenia defined as BMD T-score <-1

排除标准

  • Vitamin D deficiency defined as 25-hydroxyvitamin D (25-OH-D) below 30 nmol/l.
  • Liver and kidney disease.
  • Known diabetes or Hgb1c ≥6,5% (≥48mmol/l).
  • Severe heart disease (NYHA-Class >2).
  • Oral corticosteroid treatment within the last 3 month.
  • Anamnestic information of hip fracture or vertebral fracture.
  • Any antiosteoporotic treatment.
  • participation in other intervention studies within the last 4 weeks.

结局指标

主要结局

4 meter gait speed

时间窗: Baseline and 4 months

We will measure changes in 4 meter gait speed.

Walk distance

时间窗: Baseline and 4 months

We will measure changes in walk distance with the Six-Minute Walk Test.

Lean body mass(LBM)/Fat mass (FM) ratio.

时间窗: Baseline and 4 months

We will measure changes in the ratio LBM/FM with a DEXA-scanner.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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