10-week Leucine Supplementation in Cerebral Palsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-20

Study Completion Date

2018-10-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cerebral Palsy Cerebral Palsy, Mixed Cerebral Palsy Ataxic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be a randomised controlled pilot trial. Participants will complete testing at baseline and after 10 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

All parties will be masked from the intervention.

Study Groups

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Leucine group

To receive leucine on a daily basis for 10 weeks

Group Type EXPERIMENTAL

Leucine

Intervention Type DIETARY_SUPPLEMENT

192 mg/kg body mass/day

Control group

To receive a placebo supplement on a daily basis for 10 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

A taste and calorie-matched placebo

Interventions

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Leucine

192 mg/kg body mass/day

Intervention Type DIETARY_SUPPLEMENT

Placebo

A taste and calorie-matched placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Amino Acid

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No