Gluten-Free vs Mediterranean Diet in Rheumatoid Arthritis

Официальное название

Investigation of the Effects of a Gluten-Free Diet and the Mediterranean Diet on the Inflammatory Index, Disease Activity, and Quality of Life in Patients With Rheumatoid Arthritis.

Обзор

This study aims to evaluate the effects of different dietary interventions, including gluten-free, Mediterranean, and control diets, on disease activity, quality of life, and dietary inflammatory index in patients with rheumatoid arthritis. Participants will be followed for 12 weeks, and changes in clinical and nutritional outcomes will be assessed.

Подробное описание

This study is a 12-week dietary intervention trial conducted in patients with rheumatoid arthritis. Participants will be assigned to three different dietary groups: gluten-free diet, Mediterranean diet, and control diet. The aim is to investigate the effects of these dietary patterns on disease activity, quality of life, and dietary inflammatory index.

Disease activity will be assessed using the DAS28 score, while quality of life will be evaluated using the SF-12 questionnaire. Dietary inflammatory index (DII) will be calculated based on dietary intake data collected throughout the study period.

Participants will be followed regularly during the 12-week intervention period, and changes in clinical and nutritional outcomes will be analyzed to determine the impact of dietary patterns on rheumatoid arthritis progression and patient well-being.

Вмешательства

• Поведенческое Gluten-Free Diet Group
  Participants will follow a gluten-free diet in which all wheat, barley, rye, and their derivatives are eliminated for 12 weeks. The diet focuses on naturally gluten-free foods such as fruits, vegetables, legumes, meat, fish, rice, and corn.
• Поведенческое Mediterranean Diet
  Participants will follow a Mediterranean dietary pattern characterized by high intake of fruits, vegetables, whole grains, legumes, olive oil, and fish, with moderate consumption of dairy and low intake of red meat and processed foods for 12 weeks.
• Поведенческое Control Diet
  Participants will continue their habitual diet without any specific dietary restrictions or structured dietary guidance during the 12-week study period.

Первичные конечные точки

• Disease Activity (DAS28) [Срок оценки: 12 weeks]

Вторичные конечные точки (1)

• Quality of Life (SF-12) [Срок оценки: Baseline 12 weeks]

Критерии участия

Критерии включения

Diagnosis of rheumatoid arthritis according to ACR/EULAR criteria Age between 19-65 years Stable medication regimen for at least 3 months prior to enrollment Willingness to comply with dietary interventions and study procedures Ability to provide informed consent

Критерии исключения

Pregnancy or lactation Presence of other autoimmune or inflammatory diseases (e.g., SLE, IBD) Severe comorbidities (e.g., advanced cardiovascular, renal, or hepatic disease) Use of special diets (e.g., gluten-free diet) in the last 3 months Recent change in biologic or corticosteroid therapy (<3 months) Food allergies or intolerances affecting dietary intervention adherence Inability to comply with dietary protocol or follow-up visits

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• NCR International Hospital — Gaziantep

Идентификаторы

NCT: NCT07646262 · HasanKU-NUT-NG-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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