- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06402734
Effects of Gluten-Free Diet on Nutritional Status in Celiac Patients
May 3, 2024 updated by: Zeynep Goktas, Hacettepe University
Effects of Gluten-Free Diet on Nutritional Status and Inflammation Parameters in Adult Celiac Patients
This study examined the impact of a gluten-free diet on nutritional status and inflammation markers in adult celiac patients compared to a control group.
Twenty-six celiac patients and 26 healthy individuals participated.
Interviews, dietary records, anthropometric measurements, and blood samples were collected.
After six weeks, celiac patients showed improved adherence to the gluten-free diet and increased quality of life scores.
While initial micronutrient intake was lower in celiac patients, it improved over the study period.
However, there were no significant changes in inflammation markers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study aimed to examine the effects of a gluten-free diet on the nutritional status, anthropometric measurements, and serum levels of interferon-gamma (IFN-γ) and interleukin-15 (IL-15) in adult celiac patients, comparing them with a control group.
A total of 26 celiac patients aged 18-64 years and 26 healthy individuals as the control group were included.
Face-to-face interviews were conducted to determine participants' general characteristics, dietary habits, and physical activity status.
Additionally, a retrospective 24-hour dietary recall and food frequency questionnaire were administered to assess dietary intake.
Anthropometric measurements and blood samples were collected during the interviews.
Celiac patients received education about the gluten-free diet, and follow-up assessments were conducted six weeks later.
At the beginning, 53.8% of celiac patients reported always/mostly adhering to the gluten-free diet, which increased to 100.0% after six weeks.
The total quality of life scores significantly increased in celiac patients after six weeks.
Initial serum IL-15 levels were similar between celiac and control groups, whereas serum IFN-γ levels were significantly higher in celiac patients compared to the control group.
Study Type
Observational
Enrollment (Actual)
52
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
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Ankara, Turkey, 06100
- Hacettepe University Nutrition and Dietetics Department
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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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
The study population consisted of 26 individuals diagnosed with celiac disease, comprising 21 females and 5 males, aged between 18 and 64 years.
Additionally, a healthy control group of 26 individuals, including 20 females and 6 males, without any known diseases, was included in the study.
Description
Inclusion Criteria:
- Adults aged between 19 and 64 years old.
- Diagnosis of celiac disease.
- Willingness to participate in the study.
- Ability to adhere to the study protocol, including dietary restrictions and follow-up assessments.
- For the control group, individuals without celiac disease or any other significant health conditions.
Exclusion Criteria:
- Individuals following diets other than a gluten-free diet.
- Individuals adhering to a gluten-free diet for reasons other than celiac disease.
- Individuals with gastrointestinal diseases other than celiac disease.
- Individuals who have undergone gastrointestinal surgery.
- Individuals with mental illnesses.
- Cancer patients.
- Individuals positive for hepatitis B surface antigen or anti-hepatitis C virus antibody.
- Individuals using interferon and/or insulin.
- Pregnant or lactating women.
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 |
Intervention / Treatment |
|---|---|
|
Celiac Disease
Adult patients who were diagnosed with celiac disease were enrolled in the study.
|
Participants with a diagnosed celiac disease were following a gluten-free diet.
Study observed the adherence to the gluten-free diet for 6 weeks.
|
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Healthy Subjects
Healthy subjects with matching demographical characteristics to the celiac group were enrolled in the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum interferon-gamma level
Time Frame: 6 weeks
|
Serum interferon-gamma level was measured.
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6 weeks
|
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Serum interleukin-15 levels
Time Frame: 6 weeks
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Serum interleukin-15 level was measured.
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6 weeks
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Body weight
Time Frame: 6 weeks
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Body weight was measured using body composition analyzer device.
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6 weeks
|
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Lean body mass
Time Frame: 6 weeks
|
Lean body mass was measured using body composition analyzer device.
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6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total energy intake
Time Frame: 6 weeks
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Total energy intake was measured using food records.
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6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zeynep Goktas, PhD, Hacettepe University
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)
October 15, 2018
Primary Completion (Actual)
January 15, 2020
Study Completion (Actual)
March 15, 2020
Study Registration Dates
First Submitted
May 3, 2024
First Submitted That Met QC Criteria
May 3, 2024
First Posted (Actual)
May 7, 2024
Study Record Updates
Last Update Posted (Actual)
May 7, 2024
Last Update Submitted That Met QC Criteria
May 3, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 18/760
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to the ethical reasons participant data will not be shared.
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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