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Recruiting NCT06758817

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

No phase Interventional Diet Interventions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MedDiet+ intervention, General dietary recommendations.
Who it may be relevant to
Registry conditions: Diet Interventions. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other MedDiet+ intervention
    Study arm will consume a Mediterranean like style diet enriched in fermented foods for 12 weeks
  • Other General dietary recommendations
    Study arm will be given general healthy eating advice at baseline.

Primary outcome measures

  • DAS28-ESR [Time frame: 12 weeks]
Secondary outcome measures (12)
  • EULAR Good or Moderate Response [Time frame: 12 weeks]
  • Ultrasound score [Time frame: 12 weeks]
  • DAS28-CRP [Time frame: 12 weeks]
  • Quality of life [Time frame: 12 weeks]
  • Functional status [Time frame: 12 weeks]
  • α- and β- diversity of the gut and oral microbiota [Time frame: 12 weeks]
  • Changes in key gut microbial species [Time frame: 12 weeks]
  • Intestinal permeability [Time frame: 12 weeks]
  • Endotoxemia [Time frame: 12 weeks]
  • CRP [Time frame: 12 weeks]
  • ESR [Time frame: 12 weeks]
  • Faecal calprotectin [Time frame: 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Portugal · 2 centers
  • Unidade Local de Saude de Santa Maria — Lisbon
  • Faculdade Medicina de Lisboa — Lisbon

Publications

  • Charneca S, Hernando A, Almada-Correia I, Polido-Pereira J, Vieira A, Sousa J, Almeida AS, Motta C, Barreto G, Eklund KK, Alonso-Perez A, Gomez R, Cicci F, Mauro D, Pinho SS, Fonseca JE, Costa-Reis P, Guerreiro CS. TASTY trial: protocol for a study on the triad of nutrition, intestinal microbiota and rheumatoid arthritis. Nutr J. 2025 Apr 7;24(1):52. doi: 10.1186/s12937-025-01089-6. PMID 40189532

Identifiers

NCT: NCT06758817 · TASTY · Grant No: 2022.07462 · Grant No: 101095084 · Contract No: 22.00462 · Grant No: 101093997

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗