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

NCT ID: NCT05336513

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-12-20

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Diet Control

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.

Group Type: OTHER

Diet Control

Intervention Type: OTHER

Diet following mediterranean principles, for 15 weeks

Diet Anti-inflammatory

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.

Group Type: EXPERIMENTAL

Diet anti-inflammatory

Intervention Type: OTHER

Diet combining food items with anti-inflammatory potential, following the principles described in Rondanelli, Clinical Nutrition, 2021 Mar;40(3):661-689. doi: 10.1016/j.clnu.2020.08.020.

Interventions

Diet Control

Diet following mediterranean principles, for 15 weeks

Intervention Type: OTHER

Diet anti-inflammatory

Diet combining food items with anti-inflammatory potential, following the principles described in Rondanelli, Clinical Nutrition, 2021 Mar;40(3):661-689. doi: 10.1016/j.clnu.2020.08.020.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Particular do Algarve - HPA Saúde

UNKNOWN

Sponsor Role: collaborator

Universidade Nova de Lisboa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Faria, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Nova de Lisboa

Locations

Hospital Particular do Algarve - HPA Saúde

Portimão, , Portugal

Countries

Portugal

Other Identifiers

DAIAR

Identifier Type: -

Identifier Source: org_study_id