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10-week Leucine Supplementation in Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03668548
Recruitment Status : Unknown
Verified August 2018 by St Mary's University College.
Recruitment status was:  Enrolling by invitation
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
University of Gloucestershire
Information provided by (Responsible Party):
St Mary's University College

Tracking Information
First Submitted Date  ICMJE August 20, 2018
First Posted Date  ICMJE September 12, 2018
Last Update Posted Date September 12, 2018
Actual Study Start Date  ICMJE August 20, 2018
Estimated Primary Completion Date October 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
Skeletal muscle volume [ Time Frame: 10 weeks ]
Change in biceps brachii volume
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
  • Resting metabolic rate [ Time Frame: 10 weeks ]
    Change in resting energy expenditure and substrate metabolism
  • Perceptual well-being questionnaire [ Time Frame: 10 weeks ]
    Change in a composite measure of five different wellbeing sub-components
  • Systemic inflammation (C-Reactive protein; C-RP) [ Time Frame: 10 weeks ]
    Change in C-RP
  • Skeletal muscle strength [ Time Frame: 10 weeks ]
    Change in the biceps brachii force production
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 10-week Leucine Supplementation in Cerebral Palsy
Official Title  ICMJE The Effects of 10-week Leucine Supplementation on Muscle Growth, Body Composition, Metabolism, Inflammation and Wellbeing of Adolescents and Young Adults With Cerebral Palsy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Cerebral Palsy
  • Cerebral Palsy, Mixed
  • Cerebral Palsy Ataxic
Intervention  ICMJE
  • Dietary Supplement: Leucine
    192 mg/kg body mass/day
    Other Name: Amino Acid
  • Dietary Supplement: Placebo
    A taste and calorie-matched placebo
Study Arms  ICMJE
  • Experimental: Leucine group
    To receive leucine on a daily basis for 10 weeks
    Intervention: Dietary Supplement: Leucine
  • Placebo Comparator: Control group
    To receive a placebo supplement on a daily basis for 10 weeks
    Intervention: Dietary Supplement: Placebo
Publications * 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. 2020 Jan 21. pii: nxaa006. doi: 10.1093/jn/nxaa006. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 11, 2018)
25
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 22, 2018
Estimated Primary Completion Date October 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03668548
Other Study ID Numbers  ICMJE REC.18.85.7
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party St Mary's University College
Study Sponsor  ICMJE St Mary's University College
Collaborators  ICMJE University of Gloucestershire
Investigators  ICMJE
Principal Investigator: Nicola Theis, PhD University of Gloucestershire
PRS Account St Mary's University College
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP