Mediterranean versus Paleolithic diet for adults with rheumatoid arthritis
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | All |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Cairo, Al-Manial) |
| Trial ID | NCT07438652 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cairo, Al-Manial
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.