The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diet Interventions
- Sponsor
- Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- DAS28-ESR
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Ana Lopes
Centro Académico de Medicina de Lisboa
Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
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
- •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)
Outcomes
Primary Outcomes
DAS28-ESR
Time Frame: 12 weeks
Disease Activity Score in 28 Joints Calculated with erythrocyte sedimentation rate (DAS28-ESR), higher scores indicate higher disease activity
Secondary Outcomes
- EULAR Good or Moderate Response(12 weeks)
- Ultrasound score(12 weeks)
- DAS28-CRP(12 weeks)
- Quality of life(12 weeks)
- Functional status(12 weeks)
- α- and β- diversity of the gut and oral microbiota(12 weeks)
- Changes in key gut microbial species(12 weeks)
- Intestinal permeability(12 weeks)
- Endotoxemia(12 weeks)
- CRP(12 weeks)
- ESR(12 weeks)
- Faecal calprotectin(12 weeks)
- CD14s(12 weeks)
- LBP(12 weeks)
- IFABP(12 weeks)
- Lipid Profile(12 weeks)
- Body composition(4 th, 8 th and 12 th weeks)
- Anthropometric measurements(4 th, 8 th and 12 th weeks)
- Waist circunference(4 th, 8 th and 12 th weeks)