Effects of Gluten-Free Diet on Nutritional Status in Celiac Patients

NCT ID: NCT06402734

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-15

Study Completion Date

2020-03-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Celiac Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Celiac Disease

Adult patients who were diagnosed with celiac disease were enrolled in the study.

Adherence to Gluten Free Diet

Intervention Type BEHAVIORAL

Participants with a diagnosed celiac disease were following a gluten-free diet. Study observed the adherence to the gluten-free diet for 6 weeks.

Healthy Subjects

Healthy subjects with matching demographical characteristics to the celiac group were enrolled in the study.

No interventions assigned to this group

Interventions

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Adherence to Gluten Free Diet

Participants with a diagnosed celiac disease were following a gluten-free diet. Study observed the adherence to the gluten-free diet for 6 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Zeynep Goktas

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeynep Goktas, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University Nutrition and Dietetics Department

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GO 18/760

Identifier Type: -

Identifier Source: org_study_id

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