Physical Fitness in Celiac Disease Patients - the Effect of a Gluten Free Diet

Celiac Disease in Children Clinical Trial

Official title:

Physical Fitness in Celiac Disease Patients - the Effect of a Gluten Free Diet

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04012736
• Other study ID #: MMC059-19CTIL
• Status: Terminated
• Start date: August 13, 2019
• Est. completion date: April 5, 2022

Study information

• Verified date: August 2022
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluating the effect of Celiac disease (CD) and gluten free diet (GFD) on physical fitness parameters among CD subjects. The CD subjects will be compared to healthy controls.

Description:

This is a prospective observational cohort study. The study would take place at Meir Medical Center (Kfar-Saba, Israel), a secondary-level academic hospital. The investigators will enroll 50 newly diagnosed CD subjects. The diagnosis will be in accordance with the European Society for Gastroenterology Hepatology and Nutrition guidelines for the diagnosis of CD from 2012 (6). The investigators will also enroll 50 control subjects. The control subjects are children visiting the pediatric gastroenterology clinic. Before enrollment the investigators will rule out chronic conditions involving the gastrointestinal tract including CD.

All subjects will be enrolled after providing an informed consent and signing the consent form.

The investigators will obtain the following measurements and evaluations at and 6 months after enrollment:

1. Anthropometric measurements: Height, weight, body mass index (BMI) and total body fat will be evaluated using a TANITA scale. The z-score for each parameter will be recorded.

2. A Godin leisure-time exercise questionnaire (7) will be filled by the subjects and their parents

3. Evaluation of physical fitness by the Eurofit fitness testing (8). This series of physical fitness tests was developed to evaluate speed, stamina and strength in school-aged children.

1. Flamingo balance test

2. Seat and reach test

3. Standing broad jump test

4. Handgrip test

5. Sit-ups test

6. Bent arm hang test

7. Twenty meter endurance shuttle run test

8. Wingate anaerobic fitness test

4. Bone speed of sound test will be performed by a bone sonometer - a non-invasive ultrasound based measurement of bone density.

5. CD subjects will be evaluated for adherence to GFD via questioning by a pediatric gastroenterologist and a clinical dietitian and by serum tissue transglutaminase immunoglobulin A (IgA) level (or serum deamidated gliadin peptide immunoglobulin G level in IgA deficient subjects). This is part of the normal follow-up of CD patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 5, 2022
• Est. primary completion date: April 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Children aged 4-18y visiting the pediatric gastroenterology clinic

2. Signing a consent form

Exclusion Criteria:

1. Family history of cardiovascular diseases or sudden death before age 50y

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

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

Related Conditions & MeSH terms

• Celiac Disease
• Celiac Disease in Children

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flamingo balance test	Flamingo balance test recorded in times in 60sec (n).	6 months
Primary	Sit and reach test	Sit and reach test recorded in cm.	6 months
Primary	Standing broad jump test	Standing broad jump test recorded in cm.	6 months
Primary	Handgrip test	Handgrip test recorded kg.	6 months
Primary	Sit-ups test	Sit-ups test is recorded in times in 30sec (n).	6 months
Primary	Bent arm hang test	Bent arm hang test recorded in sec.	6 months
Primary	Twenty meter endurance shuttle run test	Twenty meter endurance shuttle run test recorded in times (n).	6 months
Secondary	Weight	Weight in kilograms. Measured with an electronic scale (model 500KL, Health o meter, McCook, IL, USA). Range 0-220kg, rounded to the nearest 0.1kg.	6 months
Secondary	Height	Height in centimeters. Measured with a wall-mounted stadiometer (model 240, Seca, Hamburg, Germany). Range 0-240cm, rounded to the nearest 0.1cm.	6 months
Secondary	Body mass index	Weight and height will be combined to report BMI in kg/m^2	6 months
Secondary	Total body fat	Total body fat in percents. Measured with a body composition scale (model MC-780U, Tanita, Arlington Heights, IL, USA).	6 months
Secondary	Bone speed of sound	Bone speed of sound in m/s. Measured with a bone sonometer (Sunlight Omnisense, Somerset, NJ, USA).	6 months