Effect of Mediterranean vs Paleolithic Diet on RA Activity, Sarcopenia and QOL: 12-Week RCT
Recruiting · NCT07438652 · Interventional (participants receive a specific treatment) · Lead sponsor: Kasr El Aini Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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).
Where it is running
1 location listed.
- Kasr Al Ainy Hospital, Faculty of Medicine, Cairo University - Cairo, Al-Manial, Egypt