10-week Leucine Supplementation in Cerebral Palsy
Primary Purpose
Cerebral Palsy, Cerebral Palsy, Mixed, Cerebral Palsy Ataxic
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Leucine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
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
Sites / Locations
- University of Gloucestershire
- St Marys Umiversity College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Leucine group
Control group
Arm Description
To receive leucine on a daily basis for 10 weeks
To receive a placebo supplement on a daily basis for 10 weeks
Outcomes
Primary Outcome Measures
Skeletal muscle volume
Change in biceps brachii volume
Secondary Outcome Measures
Resting metabolic rate
Change in resting energy expenditure and substrate metabolism
Perceptual well-being questionnaire
Change in a composite measure of five different wellbeing sub-components
Systemic inflammation (C-Reactive protein; C-RP)
Change in C-RP
Skeletal muscle strength
Change in the biceps brachii force production
Full Information
NCT ID
NCT03668548
First Posted
August 20, 2018
Last Updated
September 11, 2018
Sponsor
St Mary's University College
Collaborators
University of Gloucestershire
1. Study Identification
Unique Protocol Identification Number
NCT03668548
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
October 22, 2018 (Anticipated)
Study Completion Date
October 22, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St Mary's University College
Collaborators
University of Gloucestershire
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Cerebral Palsy, Mixed, Cerebral Palsy Ataxic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be a randomised controlled pilot trial. Participants will complete testing at baseline and after 10 weeks.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All parties will be masked from the intervention.
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Leucine group
Arm Type
Experimental
Arm Description
To receive leucine on a daily basis for 10 weeks
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
To receive a placebo supplement on a daily basis for 10 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Leucine
Other Intervention Name(s)
Amino Acid
Intervention Description
192 mg/kg body mass/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
A taste and calorie-matched placebo
Primary Outcome Measure Information:
Title
Skeletal muscle volume
Description
Change in biceps brachii volume
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Resting metabolic rate
Description
Change in resting energy expenditure and substrate metabolism
Time Frame
10 weeks
Title
Perceptual well-being questionnaire
Description
Change in a composite measure of five different wellbeing sub-components
Time Frame
10 weeks
Title
Systemic inflammation (C-Reactive protein; C-RP)
Description
Change in C-RP
Time Frame
10 weeks
Title
Skeletal muscle strength
Description
Change in the biceps brachii force production
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Theis, PhD
Organizational Affiliation
University of Gloucestershire
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Gloucestershire
City
Cheltenham
State/Province
Gloucestershire
ZIP/Postal Code
GL502RH
Country
United Kingdom
Facility Name
St Marys Umiversity College
City
London
ZIP/Postal Code
TW1 4SX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31965179
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.
Results Reference
derived
Learn more about this trial
10-week Leucine Supplementation in Cerebral Palsy
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