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AzTrials

Diet InterventionsTASTYNCT06758817

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

A study testing MedDiet+ intervention and General dietary recommendations in people with Diet Interventions, run by Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa at 2 sites in Portugal.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diet Interventions
What is being tested?
MedDiet+ intervention and General dietary recommendations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesPortugal
Study dates
2 Jan 2023to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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 locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Catarina Sousa Guerreiro, PhD contact

+351 217 999 474

cfguerreiro@medicina.ulisboa.pt

Portugal2 sites, 2 recruiting

  • Unidade Local de Saude de Santa Maria

    Lisbon, Portugal, 1649-035

    Ana Lopes, McS, +351210405814, cic@ulssm.min-saude.pt

    Patrícia Costa-Reis, MD PhD

    Recruiting

  • Faculdade Medicina de Lisboa

    Lisbon, Portugal, 1800-268

    Catarina Sousa Guerreiro, +351 217 999 474, cfguerreiro@medicina.ulisboa.pt

    Recruiting

Other trials in Portugal

About this study

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.

Read the 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.

Being tested
MedDiet+ intervention, General dietary recommendations
Keywords
Diet Interventions, rheumatoid arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MedDiet+ interventionOther

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

  • General dietary recommendationsOther

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

Study groups in NCT06758817
Study groupRoleWhat they receive
MedDiet+ interventionExperimentalThe 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).
Receives: Other: MedDiet+ intervention
General dietary recommendationsActive comparatorThis 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
Receives: Other: General dietary recommendations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DAS28-ESR

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

    Measured: 12 weeks

Secondary outcomes (19)

  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 (%).

    Measured: 12 weeks

  2. Ultrasound score

    1. 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 (%).

    Measured: 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.

    Measured: 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

    Measured: 12 weeks

  5. Functional status

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

    Measured: 12 weeks

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

    1. 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

    Measured: 12 weeks

  7. Changes in key gut microbial species

    1. 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.

    Measured: 12 weeks

  8. Intestinal permeability

    Change in the lactulose/mannitol ratio

    Measured: 12 weeks

  9. Endotoxemia

    Change in Endotoxemia measured by TLR4 activation in reporter cells

    Measured: 12 weeks

  10. CRP

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

    Measured: 12 weeks

  11. ESR

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

    Measured: 12 weeks

  12. Faecal calprotectin

    Change in faecal calprotectin (μg/g)

    Measured: 12 weeks

  13. CD14s

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

    Measured: 12 weeks

  14. LBP

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

    Measured: 12 weeks

  15. IFABP

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

    Measured: 12 weeks

  16. Lipid Profile

    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)

    Measured: 12 weeks

  17. Body composition

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

    Measured: 4 th, 8 th and 12 th weeks

  18. Anthropometric measurements

    Change in body mass index and waist circumference

    Measured: 4 th, 8 th and 12 th weeks

  19. Waist circunference

    Change in waist circumference (cm)

    Measured: 4 th, 8 th and 12 th weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study start2 Jan 2023
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06758817
Sponsor's protocol ID
TASTY
Other IDs
Grant No: 2022.07462, Grant No: 101095084, Contract No: 22.00462, Grant No: 101093997
Acronym
TASTY
Status last verified
Dec 2024
First submitted
12 Dec 2024
Last updated
6 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 40189532

Questions about this trial

What is this clinical trial studying?

A study testing MedDiet+ intervention and General dietary recommendations in people with Diet Interventions, run by Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa at 2 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Catarina Sousa Guerreiro, PhD (+351 217 999 474, cfguerreiro@medicina.ulisboa.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DAS28-ESR (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06758817, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.

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