NCT07382999 Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease
| NCT ID | NCT07382999 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Inonu University |
| Condition | Celiac Disease in Children |
| Study Type | OBSERVATIONAL |
| Enrollment | 82 participants |
| Start Date | 2026-02-12 |
| Primary Completion | 2027-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 82 participants in total. It began in 2026-02-12 with a primary completion date of 2027-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this cross-sectional observational study is to comprehensively examine the effects of adherence to a gluten-free diet on cognitive, motor, and psychosocial functions in adolescents aged 8-18 years diagnosed with celiac disease. In this context, dual-task gait performance, cognitive processing speed and attention, working memory and executive functions, muscle strength, quality of life, and fatigue levels of individuals with celiac disease who are adherent or non-adherent to a gluten-free diet will be compared with those of healthy peers. In addition, sleep patterns, pubertal development, socioeconomic indicators, and serological markers will be taken into account to evaluate the unique effects of diet adherence on neurocognitive and functional outcomes. All assessments will be conducted in accordance with a predefined standardized protocol. The order of measurement instruments will be randomized to minimize potential bias. Inclusion criteria will consist of being between 8 and 18 years of age, having a celiac disease diagnosis confirmed by serology, being followed with this diagnosis for at least six months, and obtaining written informed consent from both the participant and their parent/guardian. For the healthy control group, participants must be within the same age range and have no history of chronic neurological, psychiatric, or gastroenterological conditions. Data analysis will be performed using SPSS
Eligibility Criteria
Inclusion Criteria: * Participants aged between 8 and 18 years with a serologically confirmed diagnosis of celiac disease * Who have been followed for at least six months after diagnosisn * For whom written informed consent has been obtained from both the participant and their parent/legal guardian, will be included in the study. * The healthy control group will consist of individuals in the same age range with no history of chronic neurological, psychiatric, or gastroenterological diseases. Exclusion Criteria: * Will include the presence of an acute infection or systemic disease * Diagnosed neurological disorders (such as epilepsy or cerebral palsy); * A history of severe psychiatric disorders; conditions that may interfere with test administration, including visual, hearing, or ambulatory impairments * Initiation of psychotropic medication or changes in the current dosage within the past four weeks; the presence of unstable metabolic or endocrine disorders * Failure to obtain the required informed consent for participation.
Contact & Investigator
Zeynal YASACI
PRINCIPAL INVESTIGATOR
Inonu University
Frequently Asked Questions
Who can join the NCT07382999 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 18 Years, studying Celiac Disease in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07382999 currently recruiting?
Yes, NCT07382999 is actively recruiting participants. Contact the research team at melisailhan09@gmail.com for enrollment information.
Where is the NCT07382999 trial being conducted?
This trial is being conducted at Malatya, Turkey (Türkiye).
Who is sponsoring the NCT07382999 clinical trial?
NCT07382999 is sponsored by Inonu University. The principal investigator is Zeynal YASACI at Inonu University. The trial plans to enroll 82 participants.