10-week Leucine Supplementation in Cerebral Palsy

S

St Mary's University College

Status

Unknown

Conditions

Cerebral Palsy, Mixed
Cerebral Palsy Ataxic
Cerebral Palsy

Treatments

Dietary Supplement: Leucine
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03668548
REC.18.85.7

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

12 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

25 participants in 2 patient groups, including a placebo group

Leucine group
Experimental group
Description:
To receive leucine on a daily basis for 10 weeks
Treatment:
Dietary Supplement: Leucine
Control group
Placebo Comparator group
Description:
To receive a placebo supplement on a daily basis for 10 weeks
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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