NCT07438652

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by progressive erosive polyarthritis, impaired physical function, and reduced quality of life. Patients with RA are at increased risk of comorbidities such as cardiovascular disease, osteoporosis, infections, and mortality due to ongoing inflammation and long-term immunosuppressive therapy. Diet and nutrition have gained attention as potential modulators of RA activity, partly due to their effects on systemic inflammation, gut microbiota, and antioxidant status. The Mediterranean diet (MD), rich in fruits, vegetables, olive oil, and limited meat, has shown beneficial effects on cardiovascular health, RA symptoms, and quality of life, although evidence is still of moderate certainty. The Paleolithic diet (PD), emphasizing lean meats, fish, fruits, vegetables, nuts, and seeds while excluding grains, dairy, and processed foods, has shown promising anti-inflammatory effects in autoimmune conditions, metabolic improvements, and reduction of RA-related symptoms in preliminary studies. This randomized controlled trial will recruit adults aged 40-60 years with RA from the Kasr Al-Ainy Internal Medicine Inpatient and Outpatient Rheumatology Clinics. Participants will be randomly assigned to one of three groups: Mediterranean diet, Paleolithic diet, or control (usual diet) for 12 weeks. Baseline and post-intervention assessments will include: Nutritional assessment via Food Frequency Questionnaire and Nutrition Awareness Questionnaire Anthropometric measurements: weight, height, BMI, waist, and hip circumference RA disease activity using DAS28 Laboratory investigations: CBC, CRP, ESR, lipid profile, fasting glucose, HbA1c Patient-reported outcomes: fatigue, sleep quality, stress, and quality of life The primary objective is to evaluate whether dietary interventions improve nutritional status and RA disease activity. Secondary objectives include comparing the effects of MD and PD on fatigue, sleep, stress, and overall quality of life. The study seeks to provide evidence for dietary strategies as adjunctive management for RA, improving both clinical and metabolic outcomes.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-17
• Primary completion: 2026-06-15
• Completion: 2026-07-15
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Egypt