Suspended

Impact of Gluten-Free Diet on Physical Fitness in Celiac Disease Patients

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

From 4 to 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: August 2019
See protocol details

Summary

Principal SponsorMeir Medical Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 13, 2019

Actual date on which the first participant was enrolled.

This study aims to understand the impact of a gluten-free diet on physical fitness in children with Celiac Disease (CD). The research takes place at Meir Medical Center in Kfar-Saba, Israel, and involves 50 newly diagnosed CD patients along with 50 control subjects. The importance of this study lies in its potential to improve care for CD patients by understanding how a gluten-free diet affects their physical fitness, a crucial aspect of overall health. Participants will undergo various measurements and evaluations at enrollment and 6 months later. These include anthropometric measurements like height, weight, and body mass index, a Godin leisure-time exercise questionnaire, and a Eurofit fitness testing to evaluate speed, stamina, and strength. The Eurofit tests include the Flamingo balance test, Seat and reach test, Standing broad jump test, Handgrip test, Sit-ups test, Bent arm hang test, Twenty meter endurance shuttle run test, and Wingate anaerobic fitness test. Additionally, a bone speed of sound test will be performed to measure bone density. CD subjects will also be evaluated for their adherence to a gluten-free diet through questioning by a pediatric gastroenterologist and a clinical dietitian.

Official TitlePhysical Fitness in Celiac Disease Patients - the Effect of a Gluten Free Diet
NCT04012736
Principal SponsorMeir Medical Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Children aged 4-18y visiting the pediatric gastroenterology clinic

Signing a consent form

3 exclusion criteria prevent from participating
Family history of cardiovascular diseases or sudden death before age 50y

Chronic condition limiting the ability to perform the physical fitness tests (e.g. juvenile idiopathic arthritis)

Failure to complete the measurements and evaluations by 2 months from the date of the visit at the clinic

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Meir Medical Center

Kfar Saba, IsraelOpen Meir Medical Center in Google Maps
SuspendedOne Study Center