10-week Leucine Supplementation in Cerebral Palsy
The Effects of 10-week Leucine Supplementation on Muscle Growth, Body Composition, Metabolism, Inflammation and Wellbeing of Adolescents and Young Adults With Cerebral Palsy
1 other identifier
interventional
25
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2018
CompletedStudy Start
First participant enrolled
August 20, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2018
CompletedSeptember 12, 2018
August 1, 2018
2 months
August 20, 2018
September 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Skeletal muscle volume
Change in biceps brachii volume
10 weeks
Secondary Outcomes (4)
Resting metabolic rate
10 weeks
Perceptual well-being questionnaire
10 weeks
Systemic inflammation (C-Reactive protein; C-RP)
10 weeks
Skeletal muscle strength
10 weeks
Study Arms (2)
Leucine group
EXPERIMENTALTo receive leucine on a daily basis for 10 weeks
Control group
PLACEBO COMPARATORTo receive a placebo supplement on a daily basis for 10 weeks
Interventions
Eligibility Criteria
You may qualify if:
- A diagnosis of spastic cerebral palsy
- Aged 12-22 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St Mary's University Collegelead
- University of Gloucestershirecollaborator
Study Sites (2)
University of Gloucestershire
Cheltenham, Gloucestershire, GL502RH, United Kingdom
St Marys Umiversity College
London, TW1 4SX, United Kingdom
Related Publications (1)
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.
PMID: 31965179DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicola Theis, PhD
University of Gloucestershire
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- All parties will be masked from the intervention.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2018
First Posted
September 12, 2018
Study Start
August 20, 2018
Primary Completion
October 22, 2018
Study Completion
October 22, 2018
Last Updated
September 12, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share