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

August 23, 2022 updated by: eyal zifman, Meir Medical Center
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Flamingo balance test
Time Frame: 6 months
Flamingo balance test recorded in times in 60sec (n).
6 months
Sit and reach test
Time Frame: 6 months
Sit and reach test recorded in cm.
6 months
Standing broad jump test
Time Frame: 6 months
Standing broad jump test recorded in cm.
6 months
Handgrip test
Time Frame: 6 months
Handgrip test recorded kg.
6 months
Sit-ups test
Time Frame: 6 months
Sit-ups test is recorded in times in 30sec (n).
6 months
Bent arm hang test
Time Frame: 6 months
Bent arm hang test recorded in sec.
6 months
Twenty meter endurance shuttle run test
Time Frame: 6 months
Twenty meter endurance shuttle run test recorded in times (n).
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
Weight and height will be combined to report BMI in kg/m^2
6 months
Total body fat
Time Frame: 6 months
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
Time Frame: 6 months
Bone speed of sound in m/s. Measured with a bone sonometer (Sunlight Omnisense, Somerset, NJ, USA).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meir Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eyal Zifman, MD, Meur Medical Center, Kfar-Saba, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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