NCT06044168

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Jul 2023Dec 2027

First Submitted

Initial submission to the registry

July 14, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

July 31, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

July 14, 2023

Last Update Submit

May 4, 2026

Conditions

Spastic Cerebral Palsy

Keywords

Spastic Cerebral Palsy3D freehand ultrasoundMuscle morphologyNutritional supplementsLeucineFeasibility

Outcome Measures

Primary Outcomes (5)

  • 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.

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Functional strength test

    At the start and the end of the 10-week nutritional plan

  • 3-day food record

    Before the start of the 10-week nutritional plan

  • Global body composition

    At the start and the end of the 10-week nutritional plan

Study Arms (1)

Intervention group

EXPERIMENTAL

Receive leucine on a daily basis for 10 weeks.

Dietary Supplement: Dietary Supplement: Leucine

Interventions

Dietary Supplement: LeucineDIETARY_SUPPLEMENT

150mg/kg body mass/day

Also known as: Amino Acid
Intervention group

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • Kaat Desloovere, Prof. dr.

    Department of Rehabilitation Sciences, KU Leuven, Belgium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ineke Verreydt

CONTACT

+3216341016ineke.verreydt@kuleuven.be

Lauraine Staut

CONTACT

lauraine.staut@kuleuven.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: There will be only one group in this feasibility study. There will be no control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

July 14, 2023

First Posted

September 21, 2023

Study Start

July 31, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

BE(1)