10-week Leucine Supplementation in Cerebral Palsy

Not Applicable

• Conditions: Cerebral Palsy; Cerebral Palsy, Mixed; Cerebral Palsy Ataxic
• Interventions: Dietary Supplement: Leucine; Dietary Supplement: Placebo

• Registration Number: NCT03668548
• Lead Sponsor: St Mary's University College

Brief Summary

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

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.

Study Timeline

• Status Verified: 2018-08
• Study Start: 2018-08-20
• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-09-11
• Last Update Submitted: 2018-09-11
• Study First Posted: 2018-09-12
• Last Update Posted: 2018-09-12
• Primary Completion: 2018-10-22
• Study Completion: 2018-10-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leucine group	Leucine	To receive leucine on a daily basis for 10 weeks
Control group	Placebo	To receive a placebo supplement on a daily basis for 10 weeks

Primary Outcome Measures

Name	Time	Method
Skeletal muscle volume	10 weeks	Change in biceps brachii volume

Secondary Outcome Measures

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

Trial Locations

Locations (2)

St Marys Umiversity College; 🇬🇧 London, United Kingdom

University of Gloucestershire; 🇬🇧 Cheltenham, Gloucestershire, United Kingdom