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

NCT06758817 | Recruiting

• 5 other identifiers: TASTYGrant No: 2022.07462Grant No: 101095084Contract No: 22.00462Grant No: 101093997
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Diet Interventions

Keywords

Diet Interventions; rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• DAS28-ESR

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

  12 weeks

Secondary Outcomes (19)

• EULAR Good or Moderate Response

  12 weeks

• Ultrasound score

  12 weeks

• DAS28-CRP

  12 weeks

• Quality of life

  12 weeks

• Functional status

  12 weeks

Other Outcomes (1)

• zonulin levels, serum proteomics, and serum glycomics

  12 weeks

Study Arms (2)

MedDiet+ intervention

EXPERIMENTAL

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

General dietary recommendations

ACTIVE COMPARATOR

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

Interventions

MedDiet+ intervention OTHER

Study arm will consume a Mediterranean like style diet enriched in fermented foods for 12 weeks

MedDiet+ intervention

General dietary recommendations OTHER

Study arm will be given general healthy eating advice at baseline.

General dietary recommendations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa: lead
• Gulbenkian Institute for Molecular Medicine: collaborator

Study Sites (2)

Unidade Local de Saude de Santa Maria

Lisbon, Portugal, 1649-035, Portugal

RECRUITING

Faculdade Medicina de Lisboa

Lisbon, Portugal, 1800-268, Portugal

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Catarina Sousa Guerreiro, RD PhD

  Nutrition Lab, Faculty of Medicine, University of Lisbon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catarina Sousa Guerreiro, PhD

CONTACT

+351 217 999 474; cfguerreiro@medicina.ulisboa.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Block randomization was performed through an online software, and patients are being allocated into the intervention (MedDiet+) or control groups. Due to the nature of the trial, the participants and the dietitians responsible for implementing the study are not blinded. However, the clinicians evaluating the clinical outcome measures (disease activity score in 28 joints and the doppler ultrasound score in 32 joints) and the researchers performing the laboratory tests are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Centro Académico de Medicina de Lisboa

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 6, 2025
• Study Start: January 2, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 6, 2025

Record last verified: 2024-12

Locations

PT (2)