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Clinical Trials in Belgium / NCT06044168
Recruiting Not applicable

Feasibility Nutritional Supplements for Muscle Growth in CP

NCT06044168 · tracked via the Priya Life Science Belgium tracker
Sponsor
Universitaire Ziekenhuizen KU Leuven
Phase
Not applicable
Started
2023-07-31
Last updated
2026-05-05

Condition(s) studied

Spastic Cerebral Palsy

Investigational drug(s) / intervention(s)

Dietary Supplement: Leucine

Dietary Supplement: Leucine: 150mg/kg body mass/day

Study summary

The purpose of this study is to investigate the feasibility of a 10-week plan with a nutritional supplement (leucine) and to perform pilot analyses on the effect of leucine on macroscopic muscle morphology in children with cerebral palsy.

Eligibility

Sex
ALL
Min age
4 Years
Max age
10 Years
Healthy volunteers
No
Inclusion Criteria: Spastic Cerebral Palsy (diagnosed by a neuro-pediatrician from the CP Reference Centre of the University Hospital Leuven) * Uni- of bilateral involvement * Level II or III on the Gross Motor Function Classification System (GMFCS) * Muscle volume for the medial gastrocnemius (target muscle) of at least 20% compared to the expected muscle volume in age-matched typically developing children Exclusion Criteria: * Presence of dyskinesia or ataxia * Severe co-morbidities * Botulinum toxin treatment ten months prior to assessment * Previous orthopedic or neurosurgery * Severe ankle deformities preventing fitting in test positions * Ankle range of motion (ROM) \<30% of normal values

Primary outcome measure(s)

  • Patient adherence to the nutritional supplements — Between the start and the end of the 10-week nutritional plan.
    The patients adherence to the nutritional supplements will be based on data of the log book that will be used by the parents to record the time of consumption of the supplements. These data will be summarized per patient to define the number of successful nutritional supplements per week and describe the nutrition status during the period with nutritional supplements.
  • Overall changes in muscle volume of the medial gastrocnemius — At the start and the end of the 10-week nutritional plan
    Estimation of the muscle belly volume by 3DfUS. Muscle volume will be normalized to anthropometric growth.
  • Overall changes in muscle length of the medial gastrocnemius — At the start and the end of the 10-week nutritional plan
    Estimation of the muscle belly length, tendon length and muscle tendon unit complex length by 3DfUS. Muscle lengths will be normalized to anthropometric growth.
  • Overall changes in muscle cross-sectional area at 50% of muscle belly length — At the start and the end of the 10-week nutritional plan
    Estimation of the muscle belly cross-sectional area at 50% of the muscle belly length. Muscle cross-sectional area will be normalized to anthropometric growth.
  • Overall changes in echo-intensity of the medial gastrocnemius — At the start and the end of the 10-week nutritional plan
    Estimation of the echo-intensity by 3DfUS

Trial sites (1)

FacilityCityRegionStatus
UZ Leuven Leuven Vlaams-Brabant Recruiting

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Other trials for the same condition

The Effect of AFOs on the EMG of Children With CP Recruiting
Evaluation of Macroscopic Muscle Growth in Infants and Young Children With Spastic Cerebral Palsy Recruiting
3D-Microscopic Muscle Architecture in Cerebral Palsy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06044168 on ClinicalTrials.gov ↗ ← All trials in Belgium