Mediterranean versus Paleolithic diet for adults with rheumatoid arthritis
Official title: 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
Run by Kasr El Aini Hospital · NCT07438652 · Data updated 2026-11-12
This 12-week trial will see if following a Mediterranean or Paleolithic eating plan helps adults aged 40–60 with rheumatoid arthritis compared with continuing their usual diet.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 60 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Cairo, Al-Manial) |
| Status | Recruiting |
| Started | January 17, 2026 |
| Main results expected | June 15, 2026 |
| Study ends | July 15, 2026 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07438652 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 40–60 with rheumatoid arthritis by the 2010 ACR/EULAR criteria who do not have major comorbidities and can adhere to a prescribed diet for 12 weeks.
✕Probably not a fit
Patients with excluded comorbid conditions (for example diabetes, hypertension, gout, or thyroid dysfunction), those outside the 40–60 age range, or those unable to follow dietary changes are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with rheumatoid arthritis will be randomly assigned to follow a Mediterranean diet, a Paleolithic diet, or continue their usual diet for 12 weeks at Kasr Al-Ainy Hospital in Cairo. The trial will collect anthropometric measurements, disease activity scores (DAS28), laboratory markers (CBC, CRP, ESR, lipid profile, fasting glucose, HbA1c), and patient-reported outcomes including fatigue, sleep, and quality of life. Dietary intake will be monitored using questionnaires and nutritional assessments at baseline and after the intervention. The goal is to determine whether specific dietary patterns reduce inflammation, improve sarcopenia-related measures, and enhance overall well-being in this patient group.
Why it matters
Potential benefit: If successful, one or both diets could reduce RA activity, improve muscle health, and enhance quality of life without adding drug therapy.
How similar studies have gone: Prior studies report modest benefits of the Mediterranean diet for RA and preliminary anti-inflammatory signals for Paleolithic-style diets, but evidence is limited and not definitive.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Kasr Al Ainy Hospital, Faculty of Medicine, Cairo University
Cairo, Al-Manial, Egypt Recruiting
Study contacts
- Study coordinator: Gehad Maghraby, MD
- Email: gehad.maghraby@kasralainy.edu.eg
- Phone: +201027491363
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.