10-week Leucine Supplementation in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03668548
• Other study ID #: REC.18.85.7
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: October 22, 2018

Study information

• Verified date: August 2018
• Source: St Mary's University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: October 22, 2018
• Est. primary completion date: October 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy Ataxic
• Cerebral Palsy, Mixed
• Paralysis

Intervention

Dietary Supplement:
• Leucine
192 mg/kg body mass/day
• Placebo
A taste and calorie-matched placebo

Locations

Country	Name	City	State
United Kingdom	University of Gloucestershire	Cheltenham	Gloucestershire
United Kingdom	St Marys Umiversity College	London

Sponsors (2)

Lead Sponsor	Collaborator
St Mary's University College	University of Gloucestershire

Country where clinical trial is conducted

United Kingdom, 

Outcome

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