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| ID | Type | Description | Link |
|---|---|---|---|
| Grant No: 2022.07462 | Other Grant/Funding Number | Fundação para a Ciência e a Tecnologia, FCT | |
| Grant No: 101095084 | Other Grant/Funding Number | European Union (ENDOTARGET © Project) | |
| Contract No: 22.00462 | Other Grant/Funding Number | Swiss Secretariat - Education, Research, Innovation (SERI) | |
| Grant No: 101093997 | Other Grant/Funding Number | European Union (GlycanTrigger © Project) |
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| Name | Class |
|---|---|
| Gulbenkian Institute for Molecular Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MedDiet+ intervention | Other | Study arm will consume a Mediterranean like style diet enriched in fermented foods for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| DAS28-ESR | Disease Activity Score in 28 Joints Calculated with erythrocyte sedimentation rate (DAS28-ESR), higher scores indicate higher disease activity | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (%). | 12 weeks |
| Ultrasound score |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catarina Sousa Guerreiro, PhD | Contact | +351 217 999 474 | cfguerreiro@medicina.ulisboa.pt |
| Name | Affiliation | Role |
|---|---|---|
| Catarina Sousa Guerreiro, RD PhD | Nutrition Lab, Faculty of Medicine, University of Lisbon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade Local de Saude de Santa Maria | Recruiting | Lisbon | Portugal | 1649-035 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40189532 | Derived | 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. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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.
| General dietary recommendations | Other | Study arm will be given general healthy eating advice at baseline. |
|
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 (%). |
| 12 weeks |
| DAS28-CRP | Change in Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP), higher scores indicate worse disease activity. | 12 weeks |
| Quality of life | Change in Short Form-36 (SF-36): higher scores indicate better quality of life, score ranging from 0 to 100 | 12 weeks |
| Functional status | Change in Health Assessment Questionnaire (HAQ): higher scores indicate greater disability, score ranging from 0 to 3 | 12 weeks |
| α- and β- diversity of the gut and oral microbiota | 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 | 12 weeks |
| Changes in key gut microbial species | 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. | 12 weeks |
| Intestinal permeability | Change in the lactulose/mannitol ratio | 12 weeks |
| Endotoxemia | Change in Endotoxemia measured by TLR4 activation in reporter cells | 12 weeks |
| CRP | Change in C-reactive protein (CRP, mg/L) | 12 weeks |
| ESR | Change in erythrocyte sedimentation rate (ESR, mm/hr) | 12 weeks |
| Faecal calprotectin | Change in faecal calprotectin (μg/g) | 12 weeks |
| CD14s | Change in serum soluble CD14 (CD14s, ng/mL) | 12 weeks |
| LBP | Change in lipopolysaccharide-binding protein (LBP, ng/mL) | 12 weeks |
| IFABP | Change in intestinal fatty acids binding protein levels (IFABP, pg/mL) | 12 weeks |
| 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) | 12 weeks |
| 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) | 4 th, 8 th and 12 th weeks |
| Anthropometric measurements | Change in body mass index and waist circumference | 4 th, 8 th and 12 th weeks |
| Waist circunference | Change in waist circumference (cm) | 4 th, 8 th and 12 th weeks |
| Faculdade Medicina de Lisboa | Recruiting | Lisbon | Portugal | 1800-268 | Portugal |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |