About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
The study will include adolescents aged 8-18 years with a diagnosis of celiac disease, as well as healthy control participants from the same age group. The celiac disease group will comprise individuals who are both adherent and non-adherent to a gluten-free diet. Healthy controls will be selected from volunteers with no history of chronic neurological, psychiatric, or gastroenterological diseases.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Dual-task 10-Meter Walk Test
Following the administration of the 10-Meter Walk Test (10MWT), participants aged 6-11 years will be instructed to verbally name as many animals as they know until they are asked to stop during the test. For participants aged 12-18 years, the serial sevens task (counting backward by sevens starting from 100) will be administered concurrently with the 10MWT.
Secondary outcomes
10-meter walk test
A straight 10-meter walkway is used in the study; however, a 2-meter acceleration zone at the beginning and a 2-meter deceleration zone at the end of the walkway are provided. The stopwatch is started after the participant has walked the initial 2 meters and stopped before the final 2 meters. Participants are instructed to walk at their self-selected, natural, and comfortable walking speed. Walking time is recorded in seconds.
Timed Up And Go
Participants are instructed to stand up from a seated position, walk a distance of 3 meters, turn around a cone, return to the chair, and sit down again. The test performance is timed using a stopwatch and recorded in seconds.
Digit Span Test
The Digit Span Test (DST) will be administered via a mobile application, with the forward test performed by progressively increasing the sequence length. The score generated by the application will be recorded.
Trail Making Test
The mobile application version of the Trail Making Test (TMT) will be used. In Part A, numbers displayed within circles are arranged in ascending order. In Part B, both numbers and letters are presented, and participants are required to connect them in an alternating ascending sequence. Task completion time will be recorded as the outcome measure.
Sponsors and contacts
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