10-week Leucine Supplementation in Cerebral Palsy

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

Tracking Information

• First Submitted Date: August 20, 2018
• First Posted Date: September 12, 2018
• Last Update Posted Date: September 12, 2018
• Actual Study Start Date: August 20, 2018
• Estimated Primary Completion Date: October 22, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 11, 2018)

Skeletal muscle volume [ Time Frame: 10 weeks ]

Change in biceps brachii volume

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable

Study Design

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

• Cerebral Palsy
• Cerebral Palsy, Mixed
• Cerebral Palsy Ataxic

Intervention

• Dietary Supplement: Leucine
  192 mg/kg body mass/day
  Other Name: Amino Acid
• Dietary Supplement: Placebo
  A taste and calorie-matched placebo

Study Arms

• 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]

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: September 11, 2018): 25
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: October 22, 2018
• Estimated Primary Completion Date: October 22, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 40 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03668548
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: St Mary's University College
• Study Sponsor: St Mary's University College
• Collaborators: University of Gloucestershire

Investigators

• Principal Investigator: Nicola Theis, PhD; University of Gloucestershire

• PRS Account: St Mary's University College
• Verification Date: August 2018