Clinical trial NCT03668548: 10-week Leucine Supplementation in Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Cerebral Palsy, Mixed
Cerebral Palsy Ataxic
Lead sponsor: St Mary's University College
Sponsor class: OTHER
Collaborators: name: University of Gloucestershire
First posted: 2018-09-12
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a randomised controlled pilot trial. Participants will complete testing at baseline and after 10 weeks.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Skeletal muscle volume
timeFrame: 10 weeks
Secondary outcomes:
measure: Resting metabolic rate
timeFrame: 10 weeks
measure: Perceptual well-being questionnaire
timeFrame: 10 weeks
measure: Systemic inflammation (C-Reactive protein; C-RP)
timeFrame: 10 weeks
measure: Skeletal muscle strength
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Cheltenham
country: United Kingdom
facility: University of Gloucestershire
state: Gloucestershire
city: London
country: United Kingdom
facility: St Marys Umiversity College
Study officials:
affiliation: University of Gloucestershire
name: Nicola Theis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Theis N, Brown MA, Wood P, Waldron M. Leucine Supplementation Increases Muscle Strength and Volume, Reduces Inflammation, and Affects Wellbeing in Adults and Adolescents with Cerebral Palsy. J Nutr. 2021 Jan 4;151(1):59-64. doi: 10.1093/jn/nxaa006.