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NCT Number: NCT06758817

The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (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.

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Key information

Conditions

Diet Interventions Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculdade Medicina de Lisboa, Lisbon, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MedDiet+ intervention

Other

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

General dietary recommendations

Other

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

Primary outcomes

  1. DAS28-ESR

    Time frame: 12 weeks

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

Secondary outcomes

  1. EULAR Good or Moderate Response

    Time frame: 12 weeks

    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 (%).

  2. Ultrasound score

    Time frame: 12 weeks

    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 (%).

  3. DAS28-CRP

    Time frame: 12 weeks

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

  4. Quality of life

    Time frame: 12 weeks

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

  5. Functional status

    Time frame: 12 weeks

    Change in Health Assessment Questionnaire (HAQ): higher scores indicate greater disability, score ranging from 0 to 3

  6. α- and β- diversity of the gut and oral microbiota

    Time frame: 12 weeks

    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

  7. Changes in key gut microbial species

    Time frame: 12 weeks

    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.

  8. Intestinal permeability

    Time frame: 12 weeks

    Change in the lactulose/mannitol ratio

  9. Endotoxemia

    Time frame: 12 weeks

    Change in Endotoxemia measured by TLR4 activation in reporter cells

  10. CRP

    Time frame: 12 weeks

    Change in C-reactive protein (CRP, mg/L)

  11. ESR

    Time frame: 12 weeks

    Change in erythrocyte sedimentation rate (ESR, mm/hr)

  12. Faecal calprotectin

    Time frame: 12 weeks

    Change in faecal calprotectin (μg/g)

  13. CD14s

    Time frame: 12 weeks

    Change in serum soluble CD14 (CD14s, ng/mL)

  14. LBP

    Time frame: 12 weeks

    Change in lipopolysaccharide-binding protein (LBP, ng/mL)

  15. IFABP

    Time frame: 12 weeks

    Change in intestinal fatty acids binding protein levels (IFABP, pg/mL)

  16. Lipid Profile

    Time frame: 12 weeks

    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)

  17. Body composition

    Time frame: 4 th, 8 th and 12 th weeks

    Change in body mass index (BMI, kg/m²; weight in kilograms and height in meters will be comined to report BMI in kg/m²)

  18. Anthropometric measurements

    Time frame: 4 th, 8 th and 12 th weeks

    Change in body mass index and waist circumference

  19. Waist circunference

    Time frame: 4 th, 8 th and 12 th weeks

    Change in waist circumference (cm)

Other outcomes

  1. zonulin levels, serum proteomics, and serum glycomics

    Time frame: 12 weeks

    We will also analyse:

    i. Change in zonulin levels (ng/mL). ii. Change in serum proteomics. iii. Change in serum glycomics.

Study contacts

Contact information is provided by the study sponsor or research team.

Catarina Sousa Guerreiro, PhD

CONTACT

[email protected]

+351 217 999 474

Sponsors and collaborators

Lead sponsor

Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa

Network

Collaborators

  • Gulbenkian Institute for Molecular Medicine

Registry information

Acronym: TASTY

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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