Clinical trial NCT05336513: The Effect of an Anti-inflammatory Diet in Patients With Rheumatoid Arthritis
Official title: The Effect of an Anti-inflammatory Diet on Disease Activity and Quality of Life in Patients With Rheumatoid Arthritis - Parallel Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Anti-inflammatory diet
Disease activity
Quality of life
Rheumatoid arthritis
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
Collaborators: name: Hospital Particular do Algarve - HPA Saúde
First posted: 2022-04-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in disease activity
timeFrame: 15 weeks
measure: Changes in Quality of Life
timeFrame: 15 weeks
Secondary outcomes:
measure: Changes in C-Reactive Protein (CRP)
timeFrame: 15 weeks
measure: Changes in Erythrocyte Sedimentation Rate (ESR)
timeFrame: 15 weeks
measure: Changes in Rheumatoid Factor (RF)
timeFrame: 15 weeks
measure: Changes in Gut microbiota
timeFrame: 15 weeks
measure: Changes in weight
timeFrame: 15 weeks
measure: Changes in Body Mass Index (BMI)
timeFrame: 15 weeks
measure: Changes in waist circumference perimeter
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Portimão
country: Portugal
facility: Hospital Particular do Algarve - HPA Saúde
Study officials:
affiliation: Universidade Nova de Lisboa
name: Ana Faria, PhD
role: PRINCIPAL_INVESTIGATOR
References: