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

RecruitingNAAges 40 Years - 60 YearsAllKasr El Aini Hospital
NCT07438652 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • Mediterranean Diet (MD)
  • Paleolithic Diet (PD)
  • Control (Usual Diet)
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Where

1 site
Kasr Al Ainy Hospital, Faculty of Medicine, Cairo University
Cairo, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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