Cerebral PalsyCP-NUTRINCT07644572
Individualized Nutrition Intervention in Children With Cerebral Palsy
A study testing Individualized Nutrition Intervention in people with Cerebral Palsy and Cerebral Palsy (CP), run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if individualized nutrition support can improve nutrition, gastrointestinal symptoms, and quality of life in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy, Cerebral Palsy (CP)
- What is being tested?
- Individualized Nutrition Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 31 Dec 2026
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 to 12 years diagnosed with cerebral palsy
- Children classified as Gross Motor Function Classification System (GMFCS) levels I to III
- Children who are orally fed
- Children whose parent or legal guardian provides written informed consent
- Children who are able to complete baseline and follow-up assessments
Who cannot join
- Children who had an acute illness or serious infection within 10 days before being invited to the study
- Children with a genetic syndrome that may affect nutritional status, such as Silver-Russell syndrome or Down syndrome
- Children who are not orally fed or who receive enteral or parenteral nutrition support
- Children who participated in any dietary intervention during the last 3 months
- Children who received or started any new treatment other than routine physical therapy during the last 3 months, such as botulinum toxin injection, orthopedic surgery, or a new intensive rehabilitation program
- Children whose parent or legal guardian cannot fully understand the study procedures or does not speak Turkish
- Children who used any food supplement or vitamin supplement during the last 3 months
- Children who do not comply with the diet during the intervention or who wish to withdraw from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit
Ankara, Ankara, 06490
About this study
Official title: The Effect of Individualized Nutrition Intervention on Nutritional Status, Gastrointestinal Symptoms, and Quality of Life in Children With Cerebral Palsy: A Randomized Controlled Trial
The goal of this clinical trial is to learn if individualized nutrition support can improve nutrition, gastrointestinal symptoms, and quality of life in children with cerebral palsy.
The main questions it aims to answer are:
Read more
Does individualized nutrition support improve the nutrition status of children with cerebral palsy? Does individualized nutrition support improve gastrointestinal symptoms and quality of life?
Researchers will compare children who receive individualized nutrition support with children who receive routine care.
Participants will:
Be randomly placed into one of two groups Have their nutrition status assessed Have their gastrointestinal symptoms and quality of life assessed Receive individualized nutrition support or continue routine care
- Conditions
- Cerebral Palsy, Cerebral Palsy (CP)
- Being tested
- Individualized Nutrition Intervention
- Keywords
- Diet intervention
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Nutrition InterventionBehavioural
Participants in the intervention group will receive individualized nutrition counseling and dietary recommendations based on nutritional status, dietary intake, anthropometric measurements, gastrointestinal symptoms, and individual needs. The intervention will include assessment of dietary intake, individualized dietary planning, nutrition education, and follow-up during the 8-week study period. No drug, device, or dietary supplement will be administered as part of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | No intervention | Participants in this group will continue to receive routine care during the 8-week study period. Nutritional status, gastrointestinal symptoms, dietary quality, and quality of life will be assessed at baseline and Week 8. No individualized nutrition intervention will be provided to the control group during the study period. After completion of the Week 8 assessments, families in the control group will be provided with feedback and nutrition counseling based on the child's nutritional assessment, if needed. |
| Individualized Nutrition Intervention | Experimental | Participants in the intervention group will receive individualized nutrition counseling and dietary recommendations based on nutritional status, dietary intake, anthropometric measurements, gastrointestinal symptoms, and individual needs. The intervention will include assessment of dietary intake, individualized dietary planning, nutrition education, and follow-up during the 8-week study period. No drug, device, or dietary supplement will be administered as part of the intervention. Receives: Behavioral: Individualized Nutrition Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cerebral Palsy Quality of Life Questionnaire for Children Score
Quality of life will be assessed using the Cerebral Palsy Quality of Life Questionnaire for Children. Scores range from 0 to 100, with higher scores indicating better quality of life. The change in score from baseline to Week 8 will be compared between the individualized nutrition intervention group and the routine care group.
Measured: Baseline and week-8
Secondary outcomes (3)
Change in Body Mass Index-for-Age Z-Score
Body mass index-for-age z-score will be calculated using age- and sex-specific reference standards. The change from baseline to Week 8 will be compared between groups.
Measured: Baseline and Week 8
Change in Gastrointestinal Symptoms
Gastrointestinal symptoms will be assessed using the Gastrointestinal Symptom Rating Scale. The mean score ranges from 1 to 7, with higher scores indicating more severe gastrointestinal symptoms. The change in mean score from baseline to Week 8 will be compared between the individualized nutrition intervention group and the routine care group.
Measured: Baseline and Week 8
Change in Youth Healthy Eating Index Score
Dietary quality will be assessed using the Youth Healthy Eating Index. The total score ranges from 0 to 100, with higher scores indicating better dietary quality. The change in total score from baseline to Week 8 will be compared between the individualized nutrition intervention group and the routine care group.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 May 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beda Büşra ÖZALP ÇOLAK, Gazi University
- Investigators
- Nilüfer ACAR TEK, Prof. Dr., Study director, Gazi UniversityBülent ELBASAN, Prof. Dr., Study chair, Gazi UniversityBeda Büşra ÖZALP ÇOLAK, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644572
- Sponsor's protocol ID
- CPGAZIBDB
- Acronym
- CP-NUTRI
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves children and sensitive health-related data. Study results may be shared in aggregate form through publications or academic presentations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individualized Nutrition Intervention on Nutritional Status, Gastrointestinal Symptoms, and Quality of Life in Children With Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07644572
- Acronym / sponsor ID
- CP-NUTRI / CPGAZIBDB
- Conditions
- Cerebral Palsy, Cerebral Palsy (CP)
- Keywords
- Diet intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jun 2026 (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 goal of this clinical trial is to learn if individualized nutrition support can improve nutrition, gastrointestinal symptoms, and quality of life in children with cerebral palsy.
The main questions it aims to answer are:
Does individualized nutrition support improve the nutrition status of children with cerebral palsy? Does individualized nutrition support improve gastrointestinal symptoms and quality of life?
Researchers will compare children who receive individualized nutrition support with children who receive routine care.
Participants will:
Be randomly placed into one of two groups Have their nutrition status assessed Have their gastrointestinal symptoms and quality of life assessed Receive individualized nutrition support or continue routine care
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care | No intervention | –Participants in this group will continue to receive routine care during the 8-week study period. Nutritional status, gastrointestinal symptoms, dietary quality, and quality of life will be assessed at baseline and Week 8. No individualized nutrition intervention will be provided to the control group during the study period. After completion of the Week 8 assessments, families in the control group will be provided with feedback and nutrition counseling based on the child's nutritional assessment, if needed. |
| Individualized Nutrition Intervention | Experimental | Behavioral: Individualized Nutrition InterventionParticipants in the intervention group will receive individualized nutrition counseling and dietary recommendations based on nutritional status, dietary intake, anthropometric measurements, gastrointestinal symptoms, and individual needs. The intervention will include assessment of dietary intake, individualized dietary planning, nutrition education, and follow-up during the 8-week study period. No drug, device, or dietary supplement will be administered as part of the intervention. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6 to 12 years diagnosed with cerebral palsy
- Children classified as Gross Motor Function Classification System (GMFCS) levels I to III
- Children who are orally fed
- Children whose parent or legal guardian provides written informed consent
- Children who are able to complete baseline and follow-up assessments
Key exclusion criteria (8 listed)
- Children who had an acute illness or serious infection within 10 days before being invited to the study
- Children with a genetic syndrome that may affect nutritional status, such as Silver-Russell syndrome or Down syndrome
- Children who are not orally fed or who receive enteral or parenteral nutrition support
- Children who participated in any dietary intervention during the last 3 months
- Children who received or started any new treatment other than routine physical therapy during the last 3 months, such as botulinum toxin injection, orthopedic surgery, or a new intensive rehabilitation program
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 |
|---|---|---|
| Individualized Nutrition InterventionParticipants in the intervention group will receive individualized nutrition counseling and dietary recommendations based on nutritional status, dietary intake, anthropometric measurements, gastrointestinal symptoms, and individual needs. The intervention will include assessment of dietary intake, individualized dietary planning, nutrition education, and follow-up during the 8-week study period. No drug, device, or dietary supplement will be administered as part of the intervention. | Behavioural | Individualized Nutrition Intervention |
Primary outcome
Change in Cerebral Palsy Quality of Life Questionnaire for Children Score
Time frame: Baseline and week-8
Quality of life will be assessed using the Cerebral Palsy Quality of Life Questionnaire for Children. Scores range from 0 to 100, with higher scores indicating better quality of life. The change in score from baseline to Week 8 will be compared between the individualized nutrition intervention group and the routine care group.
3 secondary outcomes
Change in Body Mass Index-for-Age Z-Score
Time frame: Baseline and Week 8
Change in Gastrointestinal Symptoms
Time frame: Baseline and Week 8
Change in Youth Healthy Eating Index Score
Time frame: Baseline and Week 8
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 22 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves children and sensitive health-related data. Study results may be shared in aggregate form through publications or academic presentations.
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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.
Nilüfer ACAR TEK, Prof. Dr. study director
Gazi University
Bülent ELBASAN, Prof. Dr. study chair
Gazi University
Beda Büşra ÖZALP ÇOLAK principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Nutrition Intervention in people with Cerebral Palsy and Cerebral Palsy (CP), run by Gazi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 22 Jun 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cerebral Palsy Quality of Life Questionnaire for Children Score (time frame: Baseline and week-8). 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 22 Jun 2026.