Feasibility Nutritional Supplements for Muscle Growth in CP
ConditionSpastic Cerebral Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Presence of dyskinesia or ataxia
Severe co-morbidities
Botulinum toxin treatment ten months prior to assessment
Previous orthopedic or neurosurgery
Trial design
Design model
Single group
Treatments tested in this trial
Dietary Supplement: Leucine
Dietary supplement150mg/kg body mass/day
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient adherence to the nutritional supplements
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.
Time frame
Between the start and the end of the 10-week nutritional plan.2
Overall changes in muscle volume of the medial gastrocnemius
Estimation of the muscle belly volume by 3DfUS. Muscle volume will be normalized to anthropometric growth.
Time frame
At the start and the end of the 10-week nutritional plan3
Overall changes in muscle length of the medial gastrocnemius
Estimation of the muscle belly length, tendon length and muscle tendon unit complex length by 3DfUS. Muscle lengths will be normalized to anthropometric growth.
Time frame
At the start and the end of the 10-week nutritional plan4
Overall changes in muscle cross-sectional area at 50% of muscle belly length
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.
Time frame
At the start and the end of the 10-week nutritional planSecondary outcomes
1
Functional strength test
Number of repetitions of bipodal toe standing possible in 30 seconds
Time frame
At the start and the end of the 10-week nutritional plan2
3-day food record
Evaluation of the child's nutritional status, to define the amount of daily energy (kcal/kg/d) and protein (g/kg/d) intake and to estimate at which timepoint of the day the largest protein amount is consumed
Time frame
Before the start of the 10-week nutritional plan3
Global body composition
Fat mass, fat-free mass and individual variables (e.g. resistance) will be assessed via bioelectrical impedance analysis
Time frame
At the start and the end of the 10-week nutritional planSponsors and contacts
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Source ClinicalTrials.gov