Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease

NCT07382999 | Not Yet Recruiting

• 1 other identifier: 1002
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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

Conditions

Celiac Disease in Adolescents; Celiac Disease in Children

Keywords

Celiac; Cognitive function; 10 MWT; TMT A-B

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline one assestmeant

Secondary Outcomes (9)

• 10-meter walk test

  Baseline one assestmeant

• Timed Up And Go

  Baseline one assestmeant

• Digit Span Test

  Baseline one assestmeant

• Trail Making Test

  Baseline one assestmeant

• Tap Fast

  Baseline one assestmeant

Study Arms (3)

Celiac patients who adhere to a gluten-free diet

Patients with celiac disease who comply with the currently recognized sole treatment option-a strict gluten-free diet-will be included.

Celiac patients who are non-compliant with a gluten-free diet

Patients with a confirmed diagnosis of celiac disease who are non-compliant with a gluten-free diet will be included.

Healthy children without a diagnosis of celiac disease

Healthy children who have not been diagnosed with celiac disease will be included.

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

İnönü Üniversitesi Turgut Özal Tıp Merkezi

Malatya, Turkey (Türkiye)

Location

Related Publications (14)

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  BACKGROUND

• JANZ KF, LUTUCHY EM, WENTHE P, LEVY SM. Measuring Activity in Children and Adolescents Using Self-Report: PAQ-C and PAQ-A. Medicine & Science in Sports & Exercise. 2008;40(4):767-72.

  BACKGROUND

• Varni JW, Burwinkle TM, Szer IS. The PedsQL Multidimensional Fatigue Scale in pediatric rheumatology: reliability and validity. The Journal of rheumatology. 2004;31(12):2494-500.

  BACKGROUND

• Varni JW, Seid M, Kurtin PS. PedsQL™ 4.0: Reliability and Validity of the Pediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales in Healthy and Patient Populations. Medical Care. 2001;39(8):800-12.

  BACKGROUND

• Benton MJ, Spicher JM, Silva-Smith AL. Validity and reliability of handgrip dynamometry in older adults: A comparison of two widely used dynamometers. PLoS One. 2022;17(6):e0270132.

  BACKGROUND

• Candiri B, Ramazanoglu E, Talu B, Tecellioglu M. The relationship between cognitive function and functional capacity, and cognitive reserve and reaction time in patients with multiple sclerosis. Arq Neuropsiquiatr. 2024;82(9):1-9.

  BACKGROUND

• Şanlı AF, Ersöz Hüseyinsinoğlu B, Bilgiç B, Hanağası HA. Parkinson Hastalarında Algılanan ve Gerçek-Zamanlı Çift-Görev Performansının Farklı Motor-Kognitif Çift-Görev Eşleşmeleri Altında İncelenmesi. Hacettepe University Faculty of Health Sciences Journal. 2025;12(2):516-28.

  BACKGROUND

• Hosoi Y, Kamimoto T, Sakai K, Yamada M, Kawakami M. Estimation of minimal detectable change in the 10-meter walking test for patients with stroke: a study stratified by gait speed. Front Neurol. 2023;14:1219505.

  BACKGROUND

• Tendolkar P, Ibironke O, Marchesi G, De Luca A, Squeri V, Nolan KJ, et al. Relationship between Timed Up and Go performance and quantitative biomechanical measures of balance. Frontiers in Rehabilitation Sciences. 2024;Volume 5 - 2024.

  BACKGROUND

• Ding Q, Ou Z, Yao S, Wu C, Chen J, Shen J, et al. Cortical activation and brain network efficiency during dual tasks: An fNIRS study. Neuroimage. 2024;289:120545.

  BACKGROUND

• Croall ID, Tooth C, Venneri A, Poyser C, Sanders DS, Hoggard N, et al. Cognitive Impairment in Coeliac Disease with Respect to Disease Duration and Gluten-Free Diet Adherence: A Pilot Study. Nutrients. 2020;12(7).

  BACKGROUND

• Caio G, Volta U, Sapone A, Leffler DA, De Giorgio R, Catassi C, et al. Celiac disease: a comprehensive current review. BMC Med. 2019;17(1):142.

  BACKGROUND

• De Re V, Magris R, Cannizzaro R. New Insights into the Pathogenesis of Celiac Disease. Frontiers in Medicine. 2017;Volume 4 - 2017.

  BACKGROUND

• Meyer S, Rosenblum S. Examining core self-management skills among adolescents with celiac disease. J Health Psychol. 2021;26(13):2592-602

  BACKGROUND

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Zeynal YASACI

  İnönü Üniversitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melisa İLHAN

CONTACT

+905539712295; melisailhan09@gmail.com

Zeynal YASACI

CONTACT

+905075409791; zeynal.yasaci@inonu.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Lecturer

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 3, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)