The Effect of an Anti-inflammatory Diet in Patients With Rheumatoid Arthritis (DAIAR)

New University of Lisbon

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: Diet anti-inflammatory; Other: Diet Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05336513

DAIAR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18 years;
• Presence of active disease, (DAS28≥ 2.6), under adequate control and medication.
• Able to sign informed consent

Exclusion criteria

• Any type of psychological deficiency, dementia or eating disorder;
• Presence of food allergies and / or intolerances;
• Be vegetarian or use Phytotherapy or other supplements (namely, pre and probiotics);
• Use of antibiotics im the last 6 months;
• Have had previous nutritional monitoring or change in eating habits in the last 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Diet Control

Other group

Description:

Diet Control (DC): nutritional education and adherence monitoring. DC will be based on the Portuguese "Nova Roda dos Alimentos" following the principles of the Mediterranean diet.

Treatment:

Other: Diet Control

Diet Anti-inflammatory

Experimental group

Description:

Diet Anti-inflammatory (DAI): nutritional education and adherence monitoring. The DAI dietary intervention will be based on combining individual food items described as potential anti-inflammatory mitigators.

Treatment:

Other: Diet anti-inflammatory