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): StMarysUC ( St Mary's University College )

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 40 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: St Mary's University College
• ClinicalTrials.gov Identifier: NCT03668548
• Other Study ID Numbers: REC.18.85.7
• First Posted: September 12, 2018
• Last Update Posted: September 12, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Paralysis; Cerebral Palsy; Neurologic Manifestations; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases