The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)
Recruiting · NCT06758817 · Interventional (participants receive a specific treatment) · Lead sponsor: Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
View the official record on ClinicalTrials.gov →Interventions studied
General dietary recommendationsMedDiet+ intervention
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 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 (cognitive impairment/psychiatric disease)
- Pregnant or lactating individuals
Where it is running
2 locations listed.
- Unidade Local de Saude de Santa Maria - Lisbon, Portugal, Portugal
- Faculdade Medicina de Lisboa - Lisbon, Portugal, Portugal