Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06758817

The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY) Study Evaluating a Mediterranean Diet Enriched With Fermented Foods for Rheumatoid Arthritis A 12-Week Randomized Nutritional Intervention Trial

Led by Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa · Updated on 2025-01-06

100

Participants Needed

2

Research Sites

156 weeks

Total Duration

On this page

Sponsors

L

Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa

Lead Sponsor

G

Gulbenkian Institute for Molecular Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether a Mediterranean Diet enriched with fermented foods (MedDiet+) can affect gut bacteria and outcomes related to rheumatoid arthritis (RA). This trial involves 100 RA patients meeting specific criteria, aiming to explore the connections between nutrition, intestinal microbiota, and disease activity. Participants will be randomly assigned to one of two groups for 12 weeks. The intervention group will follow a personalized MedDiet+ plan supported by educational materials, food basket deliveries, and weekly culinary workshops led by dietitians. The control group will receive general healthy diet advice only at the start. The study will assess disease activity, functional status, quality of life, gut and oral microbiota changes, intestinal permeability, endotoxemia, inflammatory markers, serum proteins, and glycome profiles. Throughout the study, patients' clinical status and biological markers will be regularly monitored. Key measurements include the Disease Activity Score 28 using ESR (DAS28-ESR) after 12 weeks. Researchers will also evaluate inflammation, intestinal health, and quality of life. Participants must follow study procedures and maintain stable medication during this period to help determine the diet's impact on RA-related health.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with rheumatoid arthritis by ACR/EULAR 2010 criteria
  • Age over 18 years
  • Disease lasting more than 1 year
  • Active rheumatoid arthritis with a DAS28 score above 2.6 units
  • Stable medication for at least 12 weeks prior to study
  • Low to medium adherence to Mediterranean Diet (PREDIMED score below 10)
  • Willingness to follow the study protocol
Not Eligible

You will not qualify if you...

  • Taking prednisolone at doses of 7.5 mg/day or higher
  • Use of antibiotics within 4 weeks before starting the study
  • Regular use of NSAIDs
  • Having inflammatory or irritable bowel diseases
  • Diagnosis of celiac disease
  • Experiencing chronic diarrhea
  • Diagnosis of diabetes
  • Other immune-mediated inflammatory diseases besides rheumatoid arthritis
  • Major organ dysfunction
  • Cancer diagnosed within the last five years
  • Health conditions interfering with participation, such as cognitive impairment or psychiatric illness
  • Being pregnant or breastfeeding

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Unidade Local de Saude de Santa Maria

Lisbon, Portugal, Portugal, 1649-035

Actively Recruiting

2

Faculdade Medicina de Lisboa

Lisbon, Portugal, Portugal, 1800-268

Actively Recruiting

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Research Team

C

Catarina Sousa Guerreiro, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

TASTY trial: protocol for a study on the triad of nutrition, intestinal microbiota and rheumatoid arthritis.

Sofia Charneca, Ana Hernando, Inês Almada-Correia...

https://pubmed.ncbi.nlm.nih.gov/40189532