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

ConditionDiet Interventions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLisbon Academic Medical Center - Centro Académico de Medicina de Lisboa

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

RA patients (ACR/EULAR2010 criteria)

Age >18-years

Disease duration >1-year

Active disease (DAS28 > 2.6units)

Disqualifiers

Prednisolone dose ≥ 7.5 mg/day

Antibiotic therapy 4-weeks prior to baseline

Persistent use of NSAID's

Inflammatory or irritable bowel disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • MedDiet+ intervention

    Other intervention

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

  • General dietary recommendations

    Other intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: MedDiet+ interventionExperimental treatment 1 intervention
Group B: General dietary recommendationsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

DAS28-ESR

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

Time frame
12 weeks

Secondary outcomes

1

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 (%).

Time frame
12 weeks
2

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 (%).

Time frame
12 weeks
3

DAS28-CRP

Change in Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP), higher scores indicate worse disease activity.

Time frame
12 weeks
4

Quality of life

Change in Short Form-36 (SF-36): higher scores indicate better quality of life, score ranging from 0 to 100

Time frame
12 weeks

Other outcomes

1

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.

Time frame
12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa

Lead sponsor

Gulbenkian Institute for Molecular Medicine

Collaborator

Source ClinicalTrials.gov
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