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NCT Number: NCT06402734

Effects of Gluten-Free Diet on Nutritional Status in 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.

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Key information

Conditions

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

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University Nutrition and Dietetics Department

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Serum interferon-gamma level

    Time frame: 6 weeks

    Serum interferon-gamma level was measured.

  2. Serum interleukin-15 levels

    Time frame: 6 weeks

    Serum interleukin-15 level was measured.

  3. Body weight

    Time frame: 6 weeks

    Body weight was measured using body composition analyzer device.

  4. Lean body mass

    Time frame: 6 weeks

    Lean body mass was measured using body composition analyzer device.

Secondary outcomes

  1. Total energy intake

    Time frame: 6 weeks

    Total energy intake was measured using food records.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 7, 2024
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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