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10-week Leucine Supplementation in Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03668548
Recruitment Status : Unknown
Verified August 2018 by StMarysUC ( St Mary's University College ).
Recruitment status was:  Enrolling by invitation
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
University of Gloucestershire
Information provided by (Responsible Party):
StMarysUC ( St Mary's University College )

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Cerebral Palsy, Mixed Cerebral Palsy Ataxic Dietary Supplement: Leucine Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will be a randomised controlled pilot trial. Participants will complete testing at baseline and after 10 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All parties will be masked from the intervention.
Primary Purpose: Treatment
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
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : October 22, 2018
Estimated Study Completion Date : October 22, 2018

Arm Intervention/treatment
Experimental: Leucine group
To receive leucine on a daily basis for 10 weeks
Dietary Supplement: Leucine
192 mg/kg body mass/day
Other Name: Amino Acid

Placebo Comparator: Control group
To receive a placebo supplement on a daily basis for 10 weeks
Dietary Supplement: Placebo
A taste and calorie-matched placebo

Primary Outcome Measures :
  1. Skeletal muscle volume [ Time Frame: 10 weeks ]
    Change in biceps brachii volume

Secondary Outcome Measures :
  1. Resting metabolic rate [ Time Frame: 10 weeks ]
    Change in resting energy expenditure and substrate metabolism

  2. Perceptual well-being questionnaire [ Time Frame: 10 weeks ]
    Change in a composite measure of five different wellbeing sub-components

  3. Systemic inflammation (C-Reactive protein; C-RP) [ Time Frame: 10 weeks ]
    Change in C-RP

  4. Skeletal muscle strength [ Time Frame: 10 weeks ]
    Change in the biceps brachii force production

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668548

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United Kingdom
University of Gloucestershire
Cheltenham, Gloucestershire, United Kingdom, GL502RH
St Marys Umiversity College
London, United Kingdom, TW1 4SX
Sponsors and Collaborators
St Mary's University College
University of Gloucestershire
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Principal Investigator: Nicola Theis, PhD University of Gloucestershire
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: St Mary's University College
ClinicalTrials.gov Identifier: NCT03668548    
Other Study ID Numbers: REC.18.85.7
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases