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. 2025 Apr 7;24(1):52.
doi: 10.1186/s12937-025-01089-6.

TASTY trial: protocol for a study on the triad of nutrition, intestinal microbiota and rheumatoid arthritis

Sofia Charneca  1 , Ana Hernando  1 , Inês Almada-Correia  2   3 , Joaquim Polido-Pereira  2   3   4 , Adriana Vieira  3 , Joana Sousa  1   5 , Ana Santos Almeida  2   3 , Carla Motta  6 , Gonçalo Barreto  7 , Kari K Eklund  8   9 , Ana Alonso-Pérez  10 , Rodolfo Gómez  10 , Francesco Cicci  11 , Daniele Mauro  11 , Salomé S Pinho  12   13   14 , João Eurico Fonseca  2   3   4 , Patrícia Costa-Reis  2   3   15 , Catarina Sousa Guerreiro  1   5
Affiliations

TASTY trial: protocol for a study on the triad of nutrition, intestinal microbiota and rheumatoid arthritis

Sofia Charneca et al. Nutr J. .

Abstract

Background: The gut microbiota has been implicated in the onset and progression of Rheumatoid Arthritis (RA). It has been proposed that gut dysbiosis impairs gut barrier function, leading to alterations in mucosal integrity and immunity. This disruption allows bacterial translocation, contributing to the perpetuation of the inflammatory process. Since diet is recognised as a key environmental factor influencing the gut microbiota, nutritional interventions targeting RA activity are currently being explored. This study aims to investigate whether a dietary intervention based on a typical Mediterranean Diet enriched with fermented foods (MedDiet +) can impact the gut microbiota, intestinal permeability, and RA-related outcomes.

Methods: One hundred RA patients are being recruited at Unidade Local de Saúde (ULS) Santa Maria in Lisbon, Portugal, and randomly assigned to either the intervention (MedDiet +) or the control group. The 12-week nutritional intervention includes a personalised dietary plan following the MedDiet + pattern, along with educational resources, food basket deliveries, and clinical culinary workshops, all developed and monitored weekly by registered dietitians. The control group receives standardised general healthy diet recommendations 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.

Discussion: We anticipate obtaining integrative insights into the interplay between diet, the gut, and RA, while also exploring the underlying mechanisms driving these changes. This study, conducted by a multidisciplinary research team of registered dietitians, rheumatologists, biologists, and immunologists, aims to bridge the current gap between nutrition-related knowledge and RA.

Trial registration: Registered in ClinicalTrials.gov (NCT06758817; date of registry: January 6th 2025).

Keywords: Endotoxemia; Intestinal permeability; Mediterranean diet; Microbiota; Rheumatoid arthritis.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This trial was approved by the ethics committee of Lisbon Academic Medical Centre, CAML (Ref. Nº114/22). The ethical norms and standard conduct rules specified in the Helsinki Declaration as modified and its later amendments, or comparable ethical standards, will be followed and respected. Participants sign a written informed consent form before any study procedures. All biologic samples will be coded and stored at the Biobank-GIMM, ensuring their safety and protection. Biobank-GIMM was approved by the ethics committee of CAML and by the National Data Protection Board [79]. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
SPIRIT figure with standard protocol items of the TASTY trial. The SPRIT figure illustrates key components of the TASTY trial protocol and data collection time points from enrolment to the end of the 12 weeks. Abbreviations: Lipopolysaccharides (LPS). *Only in the MedDiet + Group
Fig. 2
Fig. 2
– Overview of the data collection throughout the trial. Visual representation of the specific variables to be collected in each phase of the study, which are identical at baseline and at the end of the trial (12th week) for both groups. Only the intervention group (MedDiet +) has in-person follow-up consultations with nutritional assessment at 4th and 8th weeks. *Sociodemographic and lifestyle data are also collected at baseline. Abbreviations: CRP: C-reactive protein; DAS28: Disease Activity Score using 28 joint counts; ESR: Erythrocyte sedimentation rate; HAQ: Health Assessment Questionnaire; I-FABP: Intestinal-fatty acid binding protein; LPS: Lipopolysaccharides; PREDIMED: Prevención con Dieta Mediterránea; SF36: 36-Item Short Form Health Survey
See this image and copyright information in PMC

References

    1. Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis. The Lancet. 2016;388(10055):2023–38. - PubMed
    1. Smolen JS, Aletaha D, Barton A, Burmester GR, Emery P, Firestein GS, et al. Rheumatoid arthritis. Nat Rev Dis Primers. 2018;4(18001). - PubMed
    1. Philippou E, Nikiphorou E. Are we really what we eat? Nutrition and its role in the onset of rheumatoid arthritis. Autoimmun Rev. 2018;17(11):1074–7. - PubMed
    1. Sadeghpour Heravi F. Gut Microbiota and Autoimmune Diseases: Mechanisms, Treatment, Challenges, and Future Recommendations. Curr Clin Microbiol Reports. 2024;11:18–33 Springer Science and Business Media Deutschland GmbH.
    1. Mousa WK, Chehadeh F, Husband S. Microbial dysbiosis in the gut drives systemic autoimmune diseases. Frontiers in Immunology. Frontiers Media S.A. 2022;13: 906258 - PMC - PubMed

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