Spastic Cerebral PalsyNut-CPNCT06044168
Feasibility Nutritional Supplements for Muscle Growth in CP
A study testing Dietary Supplement: Leucine in people with Spastic Cerebral Palsy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- Dietary Supplement: Leucine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jul 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lauraine Staut contact
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Kaat Desloovere, Prof. dr., +3216338009, kaat.desloovere@uzleuven.be
About this study
Official title: Feasibility Study: Nutritional Supplements to Support Muscle Growth in Children With Cerebral Palsy
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.
Read the 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.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- Dietary Supplement: Leucine
- Keywords
- Spastic Cerebral Palsy, 3D freehand ultrasound, Muscle morphology, Nutritional supplements, Leucine, Feasibility
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: LeucineDietary supplement
Also called Amino Acid
150mg/kg body mass/day
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Receive leucine on a daily basis for 10 weeks. Receives: Dietary Supplement: Dietary Supplement: Leucine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At the start and the end of the 10-week nutritional plan
Secondary outcomes (3)
Functional strength test
Number of repetitions of bipodal toe standing possible in 30 seconds
Measured: At the start and the end of the 10-week nutritional plan
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
Measured: Before the start of the 10-week nutritional plan
Global body composition
Fat mass, fat-free mass and individual variables (e.g. resistance) will be assessed via bioelectrical impedance analysis
Measured: At the start and the end of the 10-week nutritional plan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start31 Jul 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There will be only one group in this feasibility study. There will be no control group.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaat Desloovere, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Kaat Desloovere, Prof. dr., Principal investigator, Department of Rehabilitation Sciences, KU Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044168
- Sponsor's protocol ID
- S66961
- Acronym
- Nut-CP
- Status last verified
- Apr 2026
- First submitted
- 14 Jul 2023
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study: Nutritional Supplements to Support Muscle Growth in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06044168
- Acronym / sponsor ID
- Nut-CP / S66961
- Conditions
- Spastic Cerebral Palsy
- Keywords
- Spastic Cerebral Palsy, 3D freehand ultrasound, Muscle morphology, Nutritional supplements, Leucine, Feasibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There will be only one group in this feasibility study. There will be no control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Dietary Supplement: LeucineReceive leucine on a daily basis for 10 weeks. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Supplement: LeucineAlso: Amino Acid150mg/kg body mass/day | Dietary supplement | Intervention group |
Primary outcome
Patient adherence to the nutritional supplements
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the start and the end of the 10-week nutritional plan
Estimation of the echo-intensity by 3DfUS
3 secondary outcomes
Functional strength test
Time frame: At the start and the end of the 10-week nutritional plan
3-day food record
Time frame: Before the start of the 10-week nutritional plan
Global body composition
Time frame: At the start and the end of the 10-week nutritional plan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
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Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauraine Staut contact
Kaat Desloovere, Prof. dr. principal investigator
Department of Rehabilitation Sciences, KU Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: Leucine in people with Spastic Cerebral Palsy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ineke Verreydt (+3216341016, ineke.verreydt@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient adherence to the nutritional supplements (time frame: Between the start and the end of the 10-week nutritional plan.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.