Investigating the impact of a Mediterranean diet on rheumatoid arthritis
The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)
This study tests if following a Mediterranean diet with fermented foods can help people with rheumatoid arthritis feel better and improve their gut health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa Research network |
| Locations | 2 sites (Lisbon, Portugal and 1 other locations) |
| Trial ID | NCT06758817 on ClinicalTrials.gov |
What this trial studies
This trial aims to explore the effects of a Mediterranean Diet enriched with fermented foods (MedDiet+) on gut microbiota and outcomes related to rheumatoid arthritis (RA). A total of 100 RA patients will be recruited and randomly assigned to either the MedDiet+ intervention group or a control group receiving general dietary recommendations. Over a 12-week period, participants in the intervention group will follow a personalized dietary plan, receive educational resources, and participate in culinary workshops, all supervised by registered dietitians. The study will assess various health outcomes, including disease activity, quality of life, and microbiota changes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with active rheumatoid arthritis and low to medium adherence to the Mediterranean diet.
Not a fit: Patients with certain conditions such as diabetes, inflammatory bowel disease, or those on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve disease management and quality of life for patients with rheumatoid arthritis.
How similar studies have performed: While dietary interventions in RA have been explored, this specific approach combining the Mediterranean diet with fermented foods is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * RA patients (ACR/EULAR2010 criteria) * Age \>18-years * Disease duration \>1-year * Active disease (DAS28 \> 2.6units) * On stable medication for 12 weeks * Low/medium MedDiet adherence (PREDIMED\<10) * Willing to comply with study protocol Exclusion Criteria: * Prednisolone dose ≥ 7.5 mg/day * Antibiotic therapy 4-weeks prior to baseline * Persistent use of NSAID's * Inflammatory or irritable bowel disease * Celiac disease * Chronic diarrhea * Diabetes * Other immune-mediated inflammatory diseases besides RA * Major organ dysfunction * Cancer diagnosed in the last five years * Health conditions which may difficult participation (cognitive impairment/psychiatric disease) * Pregnant or lactating individuals
Where this trial is running
Lisbon, Portugal and 1 other locations
- Unidade Local de Saude de Santa Maria — Lisbon, Portugal, Portugal (Recruiting)
- Faculdade Medicina de Lisboa — Lisbon, Portugal, Portugal (Recruiting)
Study contacts
- Principal investigator: Catarina Sousa Guerreiro, RD PhD — Nutrition Lab, Faculty of Medicine, University of Lisbon
- Study coordinator: Catarina Sousa Guerreiro, PhD
- Email: cfguerreiro@medicina.ulisboa.pt
- Phone: +351 217 999 474
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.