10-week Leucine Supplementation in Cerebral Palsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cerebral Palsy, Cerebral Palsy, Mixed, Cerebral Palsy Ataxic

Intervention / Treatment
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* Dietary Supplement: Leucine
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of spastic cerebral palsy Aged 12-22 years Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be a randomised controlled pilot trial. Participants will complete testing at baseline and after 10 weeks.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leucine group<br>To receive leucine on a daily basis for 10 weeks | Dietary Supplement: Leucine<br>* 192 mg/kg body mass/day<br>* Other names: Amino Acid;|
| Placebo Comparator: Control group<br>To receive a placebo supplement on a daily basis for 10 weeks | Dietary Supplement: Placebo<br>* A taste and calorie-matched placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle volume | Change in biceps brachii volume | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting metabolic rate | Change in resting energy expenditure and substrate metabolism | 10 weeks | 
| Perceptual well-being questionnaire | Change in a composite measure of five different wellbeing sub-components | 10 weeks | 
| Systemic inflammation (C-Reactive protein; C-RP) | Change in C-RP | 10 weeks | 
| Skeletal muscle strength | Change in the biceps brachii force production | 10 weeks |