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

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.

Study Overview

• Status: Terminated
• Conditions: Celiac Disease in Children

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 4464402
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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. 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Celiac disease; Celiac disease subjects enrolled after diagnosis and before gluten free diet initiation
Control; Healthy controls with no chronic condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flamingo balance test	Flamingo balance test recorded in times in 60sec (n).	6 months
Sit and reach test	Sit and reach test recorded in cm.	6 months
Standing broad jump test	Standing broad jump test recorded in cm.	6 months
Handgrip test	Handgrip test recorded kg.	6 months
Sit-ups test	Sit-ups test is recorded in times in 30sec (n).	6 months
Bent arm hang test	Bent arm hang test recorded in sec.	6 months
Twenty meter endurance shuttle run test	Twenty meter endurance shuttle run test recorded in times (n).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Body mass index	Weight and height will be combined to report BMI in kg/m^2	6 months
Total body fat	Total body fat in percents. Measured with a body composition scale (model MC-780U, Tanita, Arlington Heights, IL, USA).	6 months
Bone speed of sound	Bone speed of sound in m/s. Measured with a bone sonometer (Sunlight Omnisense, Somerset, NJ, USA).	6 months

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Eyal Zifman, MD, Meur Medical Center, Kfar-Saba, Israel

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 13, 2019
• Primary Completion (ACTUAL): April 5, 2022
• Study Completion (ACTUAL): April 5, 2022

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: July 7, 2019
• First Posted (ACTUAL): July 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: pediatric; fitness; gluten free diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: MMC059-19CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No