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RECRUITINGINTERVENTIONAL

Effect of Mediterranean vs Paleolithic Diet on RA Activity, Sarcopenia and QOL: 12-Week RCT

Effect of Mediterranean and Paleolithic Dietary Interventions on Nutritional Status, Disease Activity, Sarcopenia, and Quality of Life in Adults With Rheumatoid Arthritis: A 12-Week Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study aims to evaluate the effects of Mediterranean and Paleolithic dietary interventions on nutritional status, disease activity, fatigue, sleep, and quality of life in adults with rheumatoid arthritis (RA). Participants aged 40-60 years will be randomly assigned to follow either a Mediterranean diet, a Paleolithic diet, or continue their usual diet for 12 weeks. The study will assess anthropometric measurements, disease activity score (DAS28), laboratory biomarkers (CBC, CRP, ESR, lipid profile, fasting glucose, HbA1c), and patient-reported outcomes. The trial will determine whether these diets improve RA management and overall well-being.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients classified as having rheumatoid arthritis according to the 2010 rheumatoid arthritis ACR/ EULAR classification criteria with a selected age group of 40 to 60 years old. Who Should NOT Join This Trial: - Patients with comorbidities (e.g., diabetes mellitus, hypertension, gout, thyroid dysfunction). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patients classified as having rheumatoid arthritis according to the 2010 rheumatoid arthritis ACR/ EULAR classification criteria with a selected age group of 40 to 60 years old. Exclusion Criteria: * Patients with comorbidities (e.g., diabetes mellitus, hypertension, gout, thyroid dysfunction).

Treatments Being Tested

OTHER

Mediterranean Diet (MD)

Participants will follow a Mediterranean diet for 12 weeks, emphasizing fruits, vegetables, whole grains, legumes, fish, and olive oil, with limited red meat and processed foods. Nutritional counseling and meal plans will be provided.

OTHER

Paleolithic Diet (PD)

Participants will follow a Paleolithic diet for 12 weeks, focusing on lean meats, fish, fruits, vegetables, eggs, nuts, and seeds, while excluding grains, legumes, dairy, processed foods, refined sugars, and added salt. Nutritional counseling and meal plans will be provided.

OTHER

Control (Usual Diet)

Participants will continue their habitual diet without specific dietary modifications. General healthy eating advice may be provided.

Locations (1)

Kasr Al Ainy Hospital, Faculty of Medicine, Cairo University
Cairo, Al-Manial, Egypt