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

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 Overview

• Status: Unknown
• Conditions: Cerebral Palsy; Cerebral Palsy Ataxic; Cerebral Palsy, Mixed
• Intervention / Treatment: Dietary supplement: Leucine; Dietary supplement: Placebo

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
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, TW1 4SX
    • St Marys Umiversity College
  • Gloucestershire
    • Cheltenham, Gloucestershire, United Kingdom, GL502RH
      • University of Gloucestershire

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle volume	Change in biceps brachii volume	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting metabolic rate	Change in resting energy expenditure and substrate metabolism	10 weeks
Perceptual well-being questionnaire	Change in a composite measure of five different wellbeing sub-components	10 weeks
Systemic inflammation (C-Reactive protein; C-RP)	Change in C-RP	10 weeks
Skeletal muscle strength	Change in the biceps brachii force production	10 weeks

Collaborators and Investigators

• Sponsor: St Mary's University College
• Collaborators: University of Gloucestershire
• Investigators: Principal Investigator: Nicola Theis, PhD, University of Gloucestershire

Publications and helpful links

General 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. 2021 Jan 4;151(1):59-64. doi: 10.1093/jn/nxaa006.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Anticipated): October 22, 2018
• Study Completion (Anticipated): October 22, 2018

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 12, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: REC.18.85.7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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