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

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.

Study Overview

• Status: Recruiting
• Conditions: Diet Interventions
• Intervention / Treatment: Other: MedDiet+ intervention; Other: General dietary recommendations

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catarina Sousa Guerreiro, PhD; Phone Number: +351 217 999 474; Email: cfguerreiro@medicina.ulisboa.pt

Study Locations

• Portugal
  • Lisboa, Portugal, 1800-268
    • Recruiting
    • Faculdade Medicina de Lisboa
    • Contact: Catarina Sousa Guerreiro; Phone Number: +351 217 999 474; Email: cfguerreiro@medicina.ulisboa.pt
  • Lisbon, Portugal, 1649-035
    • Recruiting
    • Unidade Local de Saúde de Santa Maria
    • Contact: Ana Lopes, McS; Phone Number: +351210405814; Email: cic@ulssm.min-saude.pt
    • Contact: Patrícia Costa-Reis, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MedDiet+ intervention; The 12-week nutritional intervention includes 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 nutritional plan includes the food portions of each food group in agreement with the MedDiet recommendations for the adult population, complemented with fermented foods including kefir (provided for daily consumption) and kombucha (provided for consumption 2x/week).	Other: MedDiet+ intervention; Study arm will consume a Mediterranean like style diet enriched in fermented foods for 12 weeks
Active Comparator: General dietary recommendations; This group receives a flyer with general recommendations on a healthy diet based on the Portuguese brief guidance for healthy eating in primary health care at baseline	Other: General dietary recommendations; Study arm will be given general healthy eating advice at baseline.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EULAR Good or Moderate Response	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 (%).	12 weeks
Ultrasound score	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 (%).	12 weeks
DAS28-CRP	Change in Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP), higher scores indicate worse disease activity.	12 weeks
Quality of life	Change in Short Form-36 (SF-36): higher scores indicate better quality of life, score ranging from 0 to 100	12 weeks
Functional status	Change in Health Assessment Questionnaire (HAQ): higher scores indicate greater disability, score ranging from 0 to 3	12 weeks
α- and β- diversity of the gut and oral microbiota	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	12 weeks
Changes in key gut microbial species	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.	12 weeks
Intestinal permeability	Change in the lactulose/mannitol ratio	12 weeks
Endotoxemia	Change in Endotoxemia measured by TLR4 activation in reporter cells	12 weeks
CRP	Change in C-reactive protein (CRP, mg/L)	12 weeks
ESR	Change in erythrocyte sedimentation rate (ESR, mm/hr)	12 weeks
Faecal calprotectin	Change in faecal calprotectin (μg/g)	12 weeks
CD14s	Change in serum soluble CD14 (CD14s, ng/mL)	12 weeks
LBP	Change in lipopolysaccharide-binding protein (LBP, ng/mL)	12 weeks
IFABP	Change in intestinal fatty acids binding protein levels (IFABP, pg/mL)	12 weeks
Lipid Profile	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)	12 weeks
Body composition	Change in body mass index (BMI, kg/m²; weight in kilograms and height in meters will be comined to report BMI in kg/m²)	4 th, 8 th and 12 th weeks
Anthropometric measurements	Change in body mass index and waist circumference	4 th, 8 th and 12 th weeks
Waist circunference	Change in waist circumference (cm)	4 th, 8 th and 12 th weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
zonulin levels, serum proteomics, and serum glycomics	We will also analyse: i. Change in zonulin levels (ng/mL). ii. Change in serum proteomics. iii. Change in serum glycomics.	12 weeks

Collaborators and Investigators

• Sponsor: Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
• Collaborators: Gulbenkian Institute for Molecular Medicine
• Investigators: Principal Investigator: Catarina Sousa Guerreiro, RD PhD, Nutrition Lab, Faculty of Medicine, University of Lisbon

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 27, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; Diet Interventions
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: TASTY; Grant No: 2022.07462 (Other Grant/Funding Number: Fundação para a Ciência e a Tecnologia, FCT); Grant No: 101095084 (Other Grant/Funding Number: European Union (ENDOTARGET © Project)); Contract No: 22.00462 (Other Grant/Funding Number: Swiss Secretariat - Education, Research, Innovation (SERI)); Grant No: 101093997 (Other Grant/Funding Number: European Union (GlycanTrigger © Project))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No