Actively Recruiting
Feasibility Study: Nutritional Supplements to Support Muscle Growth in Children With Cerebral Palsy
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-05
5
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the feasibility of a 10-week nutritional supplement plan using leucine to support muscle growth in children diagnosed with spastic cerebral palsy. Cerebral palsy is a leading cause of physical disability in childhood, characterized by muscle weakness and spasticity, with muscle growth impairments evident at young ages. The study focuses on how leucine, a key amino acid involved in muscle protein synthesis, may affect macroscopic muscle properties in this population. Participants will take a daily leucine supplement at a dose of 150 mg per kilogram of body weight for 10 weeks. This intervention group will be monitored to assess adherence to the supplementation plan and to observe any changes in muscle characteristics, including muscle volume, length, cross-sectional area, and echo-intensity of the medial gastrocnemius muscle. The study also includes evaluations of functional strength and overall body composition, with nutritional status and safety monitored through blood and urine tests. During the study, children will undergo assessments at the start and end of the 10-week period, including muscle imaging and functional tests. Researchers will collect 3-day food records before starting the supplement plan to understand baseline nutrition. The study will measure participant adherence and muscle changes to evaluate feasibility and gather data for future research. Safety monitoring includes blood and urine sampling to ensure suitability for the supplementation.
CONDITIONS
Brief Title
Feasibility Nutritional Supplements for Muscle Growth in CP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with spastic cerebral palsy by a neuro-pediatrician from the CP Reference Centre of the University Hospital Leuven
- Uni- or bilateral involvement
- Level II or III on the Gross Motor Function Classification System (GMFCS)
- Muscle volume of the medial gastrocnemius is at least 20% compared to expected volume in age-matched typically developing children
- Aged between 4 and 10 years
You will not qualify if you...
- Presence of dyskinesia or ataxia
- Severe co-morbidities
- Botulinum toxin treatment within 10 months prior to assessment
- Previous orthopedic or neurosurgery
- Severe ankle deformities that prevent fitting in test positions
- Ankle range of motion less than 30% of normal values
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants take a daily nutritional supplement (leucine) for 10 weeks to support muscle growth.
Regular visits for assessments before and after the 10-week nutritional plan
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
I
Ineke Verreydt
L
Lauraine Staut
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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