Clinical trial NCT06758817: The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)
Official title: The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diet Interventions
Keywords: Diet Interventions
rheumatoid arthritis
Lead sponsor: Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
Sponsor class: NETWORK
Collaborators: name: Gulbenkian Institute for Molecular Medicine
First posted: 2025-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Primary outcomes:
measure: DAS28-ESR
timeFrame: 12 weeks
Secondary outcomes:
measure: EULAR Good or Moderate Response
timeFrame: 12 weeks
measure: Ultrasound score
timeFrame: 12 weeks
measure: DAS28-CRP
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
measure: Functional status
timeFrame: 12 weeks
measure: α- and β- diversity of the gut and oral microbiota
timeFrame: 12 weeks
measure: Changes in key gut microbial species
timeFrame: 12 weeks
measure: Intestinal permeability
timeFrame: 12 weeks
measure: Endotoxemia
timeFrame: 12 weeks
measure: CRP
timeFrame: 12 weeks
measure: ESR
timeFrame: 12 weeks
measure: Faecal calprotectin
timeFrame: 12 weeks
measure: CD14s
timeFrame: 12 weeks
measure: LBP
timeFrame: 12 weeks
measure: IFABP
timeFrame: 12 weeks
measure: Lipid Profile
timeFrame: 12 weeks
measure: Body composition
timeFrame: 4 th, 8 th and 12 th weeks
measure: Anthropometric measurements
timeFrame: 4 th, 8 th and 12 th weeks
measure: Waist circunference
timeFrame: 4 th, 8 th and 12 th weeks
Other outcomes:
measure: zonulin levels, serum proteomics, and serum glycomics
timeFrame: 12 weeks
Locations:
city: Lisboa
country: Portugal
facility: Faculdade Medicina de Lisboa
city: Lisbon
country: Portugal
facility: Unidade Local de Saude de Santa Maria
Study officials:
affiliation: Nutrition Lab, Faculty of Medicine, University of Lisbon
name: Catarina Sousa Guerreiro, RD PhD
role: PRINCIPAL_INVESTIGATOR
References: