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
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06758817
The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)
Led by Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa · Updated on 2025-01-06
100
Participants Needed
2
Research Sites
13 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 studying the effects of a Mediterranean Diet enriched with fermented foods (MedDiet+) on gut microbiota and outcomes related to rheumatoid arthritis (RA). This trial aims to understand how this specific diet may influence disease activity, functional status, quality of life, and various biological markers in RA patients. In this randomized trial, 100 RA patients will be assigned to either the MedDiet+ intervention group or a control group. The MedDiet+ group will follow a 12-week personalized dietary plan that includes fermented foods like kefir and kombucha, supported by educational materials, food basket deliveries, and weekly culinary workshops led by dietitians. The control group will receive general healthy eating advice at the start of the study. Participants will undergo assessments throughout the 12 weeks to measure disease activity, ultrasound scores, inflammation markers, gut and oral microbiota diversity, intestinal permeability, and body composition. Researchers will monitor quality of life and functional status as well. The study includes blood tests, stool and oral samples, and various clinical evaluations to track changes. The total participation lasts 12 weeks, with multiple evaluations during this period.
CONDITIONS
Brief Title
The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Diagnosed with rheumatoid arthritis according to ACR/EULAR2010 criteria
- Age over 18 years
- Disease duration longer than 1 year
- Active disease with DAS28 score greater than 2.6 units
- On stable medication for at least 12 weeks
- Low or medium adherence to Mediterranean Diet (PREDIMED score less than 10)
- Willing to follow the study protocol
You will not qualify if you...
- Taking prednisolone at doses equal to or higher than 7.5 mg/day
- Received antibiotic therapy within 4 weeks before baseline
- Persistent use of non-steroidal anti-inflammatory drugs (NSAIDs)
- Having inflammatory or irritable bowel disease
- Diagnosed with celiac disease
- Experiencing chronic diarrhea
- Having diabetes
- Diagnosed with other immune-mediated inflammatory diseases besides rheumatoid arthritis
- Major organ dysfunction
- Cancer diagnosed within the last five years
- Health conditions that may make participation difficult (such as cognitive impairment or psychiatric disease)
- Pregnant or breastfeeding individuals
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants follow a 12-week nutritional intervention or general dietary recommendations to assess effects on rheumatoid arthritis and related health markers.
Weekly visits for up to 12 weeks
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
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