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Clinical Trial Summary

Rheumatoid arthritis (RA) is an autoimmune disease that affects 0.5-1% of the population and in which his remission is not always achieved, affecting physical and mental well-being and quality of life (QL). As a complement to pharmacotherapy, dietary intervention should be evaluated as a treatment option. The main objective of this parallel controlled randomized clinical trial is to check the effect of an anti-inflammatory dietary intervention, compared to a diet based on the principles of the Mediterranean diet (control), on disease activity (AD) and improving QL. Patients will be instructed to follow an anti-inflammatory diet (DAI) or a control diet (DC) for 6 months. The AD and QL will be evaluated at the end of the intervention. As there are no dietary guidelines for RA, this study aims to provide scientific evidence about the impact of diet therapy on reducing AD and improving QL.


Clinical Trial Description

The main objective of this trial is to check the effect of an DAI, compared to a DC, on reducing AD and improving QL. As secondary objectives, it is intended to investigate the relationship of DAI with inflammatory markers and with the modulation of the composition / diversity of the intestinal microbiota, in comparison with a DC. This study combines all dietary components with an anti-inflammatory effect, thus allowing the possibility of evaluating the full potential of dietary treatment in the disease, including intestinal microbiota modulation. These results are intended to further contribute to clinical decision making and better evidence-based treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05336513
Study type Interventional
Source Universidade Nova de Lisboa
Contact
Status Completed
Phase N/A
Start date April 1, 2021
Completion date December 20, 2021

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