RECRUITINGINTERVENTIONAL
The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
OTHER
MedDiet+ intervention
Study arm will consume a Mediterranean like style diet enriched in fermented foods for 12 weeks
OTHER
General dietary recommendations
Study arm will be given general healthy eating advice at baseline.
Locations (2)
Unidade Local de Saude de Santa Maria
Lisbon, Portugal, Portugal
Faculdade Medicina de Lisboa
Lisbon, Portugal, Portugal