NCT06758817

The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The main goal of this trial is to investigate whether a dietary intervention based on a typical Mediterranean Diet enriched with fermented foods (MedDiet+) can impact gut microbiota and RA-related outcomes.

Detailed description

100 RA patients will be recruited at ULS Santa Maria in Lisbon, Portugal, and randomly assigned to either the intervention (MedDiet+) or the control group. The 12-week nutritional intervention will include a personalized dietary plan based on the MedDiet+ pattern, educational resources, food basket deliveries, and clinical culinary workshops, all developed and monitored weekly by registered dietitians. The control group will receive general recommendations for a healthy diet at baseline. The intervention's effects will be assessed by evaluating disease activity, functional status, quality of life, intestinal permeability, endotoxemia, inflammatory biomarkers, intestinal and oral microbiota, serum proteomics, and serum glycome profile characterisation.

Conditions

• Diet Interventions

Interventions

Type	Name	Description
OTHER	MedDiet+ intervention	Study arm will consume a Mediterranean like style diet enriched in fermented foods for 12 weeks
OTHER	General dietary recommendations	Study arm will be given general healthy eating advice at baseline.

Timeline

• Start date: 2023-01-02
• Primary completion: 2025-09-30
• Completion: 2025-12-31
• First posted: 2025-01-06
• Last updated: 2025-01-06

Locations

2 sites across 1 country: Portugal