Clinical trial Recruiting at 1 site Interventional Ages 40 to 60

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 typeInterventional
Ages40 Years to 60 Years
SexAll
Enrollment75 (estimated)
SponsorKasr El Aini Hospital
Academic / other
Locations1 site (Cairo, Al-Manial)
StatusRecruiting
StartedJanuary 17, 2026
Main results expectedJune 15, 2026
Study endsJuly 15, 2026
Registry record updatedFebruary 27, 2026
Trial IDNCT07438652 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.