Nut-CP: Feasibility Nutritional Supplements for Muscle Growth in CP

Sponsor

Universitaire Ziekenhuizen KU Leuven (Other)

Overall Status

Recruiting

CT.gov ID

NCT06044168

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Spastic Cerebral Palsy	Dietary Supplement: Dietary Supplement: Leucine	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

There will be only one group in this feasibility study. There will be no control group.There will be only one group in this feasibility study. There will be no control group.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 31, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Receive leucine on a daily basis for 10 weeks.	Dietary Supplement: Dietary Supplement: Leucine 150mg/kg body mass/day Other Names: Amino Acid

Arm

Intervention/Treatment

Experimental: Intervention group

Receive leucine on a daily basis for 10 weeks.

Dietary Supplement: Dietary Supplement: Leucine

150mg/kg body mass/day

Other Names:

Amino Acid

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Functional strength test [At the start and the end of the 10-week nutritional plan]
Number of repetitions of bipodal toe standing possible in 30 seconds
3-day food record [Before the start of the 10-week nutritional plan]
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
Global body composition [At the start and the end of the 10-week nutritional plan]
Fat mass, fat-free mass and individual variables (e.g. resistance) will be assessed via bioelectrical impedance analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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