The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)

Not Applicable

Recruiting

• Conditions: Diet Interventions

• Registration Number: NCT06758817
• Lead Sponsor: Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa

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.

Study Timeline

• Study Start: 2023-01-02
• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-27
• Last Update Submitted: 2024-12-27
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
DAS28-ESR	12 weeks	Disease Activity Score in 28 Joints Calculated with erythrocyte sedimentation rate (DAS28-ESR), higher scores indicate higher disease activity

Secondary Outcome Measures

Name	Time	Method
EULAR Good or Moderate Response	12 weeks	Proportion of patients achieving moderate or good response based on European Alliance of Associations for Rheumatology (EULAR) criteria; measured with Disease Activity Score using Erythrocyte Sedimentation Rate) (DAS28-ESR\<2.6 (%).
Ultrasound score	12 weeks	i. Change in ultrasound score for 32 joints assessed using a 0-3 scale for grey scale and power Doppler, score (0-3) per joint, higher scores indicate worse disease activity.; ii. Proportion of patients achieving a 10% improvement in the ultrasound joint score (%).
DAS28-CRP	12 weeks	Change in Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP), higher scores indicate worse disease activity.
Quality of life	12 weeks	Change in Short Form-36 (SF-36): higher scores indicate better quality of life, score ranging from 0 to 100
Functional status	12 weeks	Change in Health Assessment Questionnaire (HAQ): higher scores indicate greater disability, score ranging from 0 to 3
α- and β- diversity of the gut and oral microbiota	12 weeks	i. Change in α-diversity: changes in alpha diversity between the different groups using the Chao-1 index, Phylogenetic Diversity index, Simpson index, and Shannon index.; ii. Change in β-diversity: we will perform Principal Coordinates Analysis (PCoA) using Bray-Curtis dissimilarity, Weighted UniFrac, and Unweighted
Changes in key gut microbial species	12 weeks	i. Change in the relative abundance of Lactobacillus/ Limosilactobacillus and Bifidobacterium, relative abundance in percentage. ii. Change in butyrate-producing species, relativ abundance in percentage. iii. Change in H₂S-producing species, relative abundance in percentage.
Intestinal permeability	12 weeks	Change in the lactulose/mannitol ratio
Endotoxemia	12 weeks	Change in Endotoxemia measured by TLR4 activation in reporter cells
CRP	12 weeks	Change in C-reactive protein (CRP, mg/L)
ESR	12 weeks	Change in erythrocyte sedimentation rate (ESR, mm/hr)
Faecal calprotectin	12 weeks	Change in faecal calprotectin (μg/g)
CD14s	12 weeks	Change in serum soluble CD14 (CD14s, ng/mL)
LBP	12 weeks	Change in lipopolysaccharide-binding protein (LBP, ng/mL)
IFABP	12 weeks	Change in intestinal fatty acids binding protein levels (IFABP, pg/mL)
Lipid Profile	12 weeks	i.Change in triglycerides (mg/dL) ii.Change in total cholesterol (mg/dL) iii.Change in high-density lipoprotein cholesterol (HDL, mg/dL) iv.Change in low-density lipoprotein cholesterol (LDL, mg/dL)
Body composition	4 th, 8 th and 12 th weeks	Change in body mass index (BMI, kg/m²; weight in kilograms and height in meters will be comined to report BMI in kg/m²)
Anthropometric measurements	4 th, 8 th and 12 th weeks	Change in body mass index and waist circumference
Waist circunference	4 th, 8 th and 12 th weeks	Change in waist circumference (cm)

Trial Locations

Locations (2)

Faculdade Medicina de Lisboa; 🇵🇹 Lisboa, Portugal

Unidade Local de Saude de Santa Maria; 🇵🇹 Lisbon, Portugal