Cerebral Palsy, Cerebral Palsy Ataxic, Cerebral Palsy, Mixed
Conditions
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.
Interventions
DIETARY_SUPPLEMENTLeucine
192 mg/kg body mass/day
DIETARY_SUPPLEMENTPlacebo
A taste and calorie-matched placebo
Sponsors
University of Gloucestershire
St Mary's University College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All parties will be masked from the intervention.
Intervention model description
The study will be a randomised controlled pilot trial. Participants will complete testing at baseline and after 10 weeks.
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal muscle volume | 10 weeks | Change in biceps brachii volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting metabolic rate | 10 weeks | Change in resting energy expenditure and substrate metabolism |
| Perceptual well-being questionnaire | 10 weeks | Change in a composite measure of five different wellbeing sub-components |
| 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 |
Countries
United Kingdom
Outcome results
None listed