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

Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa

Status: Enrolling

Conditions: Diet Interventions

Treatments: Other: MedDiet+ intervention; Other: General dietary recommendations

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06758817

TASTY

Grant No: 101095084 (Other Grant/Funding Number)

Grant No: 2022.07462 (Other Grant/Funding Number)

Grant No: 101093997 (Other Grant/Funding Number)

Contract No: 22.00462 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

MedDiet+ intervention

Experimental group

Description:

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).

Treatment:

Other: MedDiet+ intervention

General dietary recommendations

Active Comparator group

Description:

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

Treatment:

Other: General dietary recommendations