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临床试验/NCT03668548
NCT03668548Unknown不适用

The Effects of 10-week Leucine Supplementation on Muscle Growth, Body Composition, Metabolism, Inflammation and Wellbeing of Adolescents and Young Adults With Cerebral Palsy

St Mary's University College4 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年8月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
25
试验地点
4
主要终点
Skeletal muscle volume

研究概览

简要总结

The purpose of this study is to assess the effects of 10-weeks leucine supplementation on muscle growth, metabolism, body composition, inflammation and wellbeing in adolescents and young adults with CP.

详细描述

Cerebral palsy (CP) is caused by damage to the developing brain and descending pathways, leading to altered patterns of growth and development. Those with CP may encounter early symptoms of paresis and spasticity, leading to progressive secondary musculoskeletal complications, including increased muscle atrophy and abnormal growth of contractile and non-contractile tissue. This causes significant weakness of the muscle and compromises daily motor function, leading to substantial declines in activities of daily living and independence. As such, interventions aimed at increasing muscle mass or preventing muscle atrophy for those with CP must be established. It is well established that dietary protein ingestion stimulates protein synthesis and inhibits proteolytic pathways, resulting in a positive protein balance and net muscle mass gain. In particular, leucine (a branched chain amino acid; BCAA), has been used to facilitate protein synthesis and muscle growth. Leucine also has anti-inflammatory roles, some of which are central in origin and have been shown to effect mood and features of wellbeing. However, there has been no investigation of the effects of leucine supplementation on any of these parameters in CP. Therefore, the purpose of this study is to assess the effects of 10-weeks leucine supplementation on muscle growth, metabolism, body composition, inflammation and wellbeing in adolescents and young adults with CP.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

All parties will be masked from the intervention.

入排标准

年龄范围
12 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • A diagnosis of spastic cerebral palsy
  • Aged 12-22 years

排除标准

  • Orthopaedic surgery of the upper-limbs in the past 12 months
  • Botulinum toxin type A injections in the past 6 months
  • Serial casting in the past 6 months
  • Insufficient cognitive understanding to comply with the assessment procedures and intervention
  • Liver and/or kidney dysfunction

研究组 & 干预措施

Leucine group

Experimental

To receive leucine on a daily basis for 10 weeks

干预措施: Leucine (Dietary Supplement)

Control group

Placebo Comparator

To receive a placebo supplement on a daily basis for 10 weeks

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Skeletal muscle volume

时间窗: 10 weeks

Change in biceps brachii volume

次要结局

  • Resting metabolic rate(10 weeks)
  • Systemic inflammation (C-Reactive protein; C-RP)(10 weeks)
  • Skeletal muscle strength(10 weeks)
  • Perceptual well-being questionnaire(10 weeks)

研究者

发起方
St Mary's University College
申办方类型
Other
责任方
Sponsor

研究点 (4)

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10-week Leucine Supplementation in Cerebral Palsy | 临床试验