The Effects of 10-week Leucine Supplementation on Muscle Growth, Body Composition, Metabolism, Inflammation and Wellbeing of Adolescents and Young Adults With Cerebral Palsy
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
- 否
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
To receive leucine on a daily basis for 10 weeks
干预措施: Leucine (Dietary Supplement)
Control group
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)
