Clinical trial NCT06402734: Effects of Gluten-Free Diet on Nutritional Status in Celiac Patients
Official title: Effects of Gluten-Free Diet on Nutritional Status and Inflammation Parameters in Adult Celiac Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Keywords: celiac disease
inflammation
interferon-gamma
interleukin-15
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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\&#39; 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum interferon-gamma level
timeFrame: 6 weeks
measure: Serum interleukin-15 levels
timeFrame: 6 weeks
measure: Body weight
timeFrame: 6 weeks
measure: Lean body mass
timeFrame: 6 weeks
Secondary outcomes:
measure: Total energy intake
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Nutrition and Dietetics Department
Study officials:
affiliation: Hacettepe University
name: Zeynep Goktas, PhD
role: PRINCIPAL_INVESTIGATOR
References: