RecruitingRecruiting
The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)
NCT06758817 · Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
100 RA patients will be recruited at ULS Santa Maria in Lisbon, Portugal, and randomly assigned to either the intervention (MedDiet+) or the control group. The 12-week nutritional intervention will include a personalized dietary plan based on the MedDiet+ pattern, educational resources, food basket deliveries, and clinical culinary workshops, all developed and monitored weekly by registered dietitians. The control group will receive general recommendations for a healthy diet at baseline. The intervention's effects will be assessed by evaluating disease activity, functional status, quality of life, intestinal permeability, endotoxemia, inflammatory biomarkers, intestinal and oral microbiota, serum proteomics, and serum glycome profile characterisation.
Eligibility criteria
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
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2023-01-02
Estimated completion: 2025-12-31
Last updated: 2025-01-06
Interventions
Other: MedDiet+ interventionOther: General dietary recommendations
Primary outcomes
- • DAS28-ESR (12 weeks)
Sponsor
Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa · network
With: Gulbenkian Institute for Molecular Medicine
Contacts & investigators
ContactCatarina Sousa Guerreiro, PhD · contact · cfguerreiro@medicina.ulisboa.pt · +351 217 999 474
InvestigatorCatarina Sousa Guerreiro, RD PhD · principal_investigator, Nutrition Lab, Faculty of Medicine, University of Lisbon
All locations (2)
Unidade Local de Saude de Santa MariaRecruiting
Lisbon, Portugal, Portugal
Faculdade Medicina de LisboaRecruiting
Lisbon, Portugal, Portugal