Feasibility Nutritional Supplements for Muscle Growth in CP

Spastic Cerebral Palsy Clinical Trial

— Nut-CP  

Official title:

Feasibility Study: Nutritional Supplements to Support Muscle Growth in Children With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06044168
• Other study ID #: S66961
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Ineke Verreydt
• Phone: +3216341016
• Email: ineke.verreydt[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Cerebral palsy (CP) is the largest cause of childhood physical disability, with a prevalence of 2 to 3 per 1000 live births. While the disorder is caused by a non-progressive lesion in the developing brain, musculoskeletal alterations progress with age. The observed neuromuscular symptoms mainly involve spasticity and muscle weakness. Macroscopic lower limb muscle properties in CP, i.e. reduced muscle volume, length, anatomical cross-sectional area (CSA), and fiber CSA, have been reported, providing convincing evidence for impaired muscle growth in children with CP, already at young ages. Nutritional supplements may improve muscle strength and cause muscle hypertrophy. Within the muscle, protein synthesis depends on the availability of the branched chain amino acids (BCAA), and mainly on the presence of leucine. This stimulatory effect is thought to be primarily mediated by the upregulation of mRNA translation via enhanced signaling through the mTOR pathway. BCAA or leucine supplements have been widely used to improve muscle strength and achieve hypertrophy. In paediatric CP groups, such muscular effect of nutritional supplementation on macroscopic intrinsic muscle properties (i.e. muscle volume, anatomical CSA and muscle belly length) has not yet been studied. Therefore, a feasibility study will be carried out 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 five children with cerebral palsy. This feasibility study will provide proof of concept of the administration plan of the leucine supplement and of the study design. Additionally, it will provide data for power analyses, that will be used in a future comprehensive study, investigating the effect of leucine on macroscopic muscle properties in children with cerebral palsy. To cover safety issues blood and urine sampling will be performed to objectify the patient's nutritional state and to exclude underlying disorders that would contraindicate the use of protein supplements.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spastic Cerebral Palsy

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Between the start and the end of the 10-week nutritional plan.
Primary	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.	At the start and the end of the 10-week nutritional plan
Primary	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.	At the start and the end of the 10-week nutritional plan
Primary	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.	At the start and the end of the 10-week nutritional plan
Primary	Overall changes in echo-intensity of the medial gastrocnemius	Estimation of the echo-intensity by 3DfUS	At the start and the end of the 10-week nutritional plan
Secondary	Functional strength test	Number of repetitions of bipodal toe standing possible in 30 seconds	At the start and the end of the 10-week nutritional plan
Secondary	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	Before the start of the 10-week nutritional plan
Secondary	Global body composition	Fat mass, fat-free mass and individual variables (e.g. resistance) will be assessed via bioelectrical impedance analysis	At the start and the end of the 10-week nutritional plan