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

Celiac Disease Clinical Trial

Official title:

Effects of Gluten-Free Diet on Nutritional Status and Inflammation Parameters in Adult Celiac Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06402734
• Other study ID #: GO 18/760
• Status: Completed
• Start date: October 15, 2018
• Est. completion date: March 15, 2020

Study information

• Verified date: May 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Turkey	Hacettepe University Nutrition and Dietetics Department	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum interferon-gamma level	Serum interferon-gamma level was measured.	6 weeks
Primary	Serum interleukin-15 levels	Serum interleukin-15 level was measured.	6 weeks
Primary	Body weight	Body weight was measured using body composition analyzer device.	6 weeks
Primary	Lean body mass	Lean body mass was measured using body composition analyzer device.	6 weeks
Secondary	Total energy intake	Total energy intake was measured using food records.	6 weeks