RecruitingNot ApplicableNCT06758817
The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)
Sponsor
Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
Enrollment
100 participants
Start Date
Jan 2, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria12
- 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
Interventions
OTHERMedDiet+ intervention
Study arm will consume a Mediterranean like style diet enriched in fermented foods for 12 weeks
OTHERGeneral dietary recommendations
Study arm will be given general healthy eating advice at baseline.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06758817