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

NCT06402734 | Completed

• 1 other identifier: GO 18/760
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Celiac Disease

Keywords

celiac disease; inflammation; interferon-gamma; interleukin-15

Outcome Measures

Primary Outcomes (4)

• Serum interferon-gamma level

  Serum interferon-gamma level was measured.

  6 weeks

• Serum interleukin-15 levels

  Serum interleukin-15 level was measured.

  6 weeks

• Body weight

  Body weight was measured using body composition analyzer device.

  6 weeks

• Lean body mass

  Lean body mass was measured using body composition analyzer device.

  6 weeks

Secondary Outcomes (1)

• Total energy intake

  6 weeks

Study Arms (2)

Celiac Disease

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

Behavioral: Adherence to Gluten Free Diet

Healthy Subjects

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

Interventions

Adherence to Gluten Free Diet 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.

Celiac Disease

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Nutrition and Dietetics Department

Ankara, 06100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples were collected from all subjects.

MeSH Terms

Conditions

Celiac Disease; Inflammation

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zeynep Goktas, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: October 15, 2018
• Primary Completion: January 15, 2020
• Study Completion: March 15, 2020
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)