RecruitingNot ApplicableNCT07438652

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

Sponsor

Kasr El Aini Hospital

Enrollment

75 participants

Start Date

Jan 17, 2026

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis (RA)

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.

Eligibility

Min Age: 40 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two popular diets — the Mediterranean diet and the Paleolithic (Paleo) diet — to see which one better reduces inflammation, muscle loss, and improves quality of life in people with rheumatoid arthritis (RA), a condition where the immune system attacks the joints. **You may be eligible if...** - You have been diagnosed with rheumatoid arthritis according to standard classification guidelines - You are between 40 and 60 years old **You may NOT be eligible if...** - You have other significant health conditions such as diabetes, high blood pressure (hypertension), gout, or thyroid problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMediterranean 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.

OTHERPaleolithic 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.

OTHERControl (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

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NCT07438652

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