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/40189532Actively Recruiting
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
L
Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
Lead Sponsor
G
Gulbenkian Institute for Molecular Medicine
Collaborating Sponsor
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
The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)
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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
C
Catarina Sousa Guerreiro, PhD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Sofia Charneca, Ana Hernando, Inês Almada-Correia...
https://pubmed.ncbi.nlm.nih.gov/40189532