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

Last updated: December 27, 2024
Sponsor: Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Rheumatoid Arthritis

Treatment

MedDiet+ intervention

General dietary recommendations

Clinical Study ID

NCT06758817
TASTY
Grant No: 2022.07462
Grant No: 101093997
Contract No: 22.00462
Grant No: 101095084
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 (cognitiveimpairment/psychiatric disease)

  • Pregnant or lactating individuals

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: MedDiet+ intervention
Phase:
Study Start date:
January 02, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Faculdade Medicina de Lisboa

    Lisboa, 1800-268
    Portugal

    Active - Recruiting

  • Unidade Local de Saude de Santa Maria

    Lisbon, 1649-035
    Portugal

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.