NCT05336513

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

March 25, 2022

Last Update Submit

April 19, 2022

Conditions

Rheumatoid Arthritis

Keywords

Anti-inflammatory dietDisease activityQuality of lifeRheumatoid arthritis

Outcome Measures

Primary Outcomes (2)

  • Changes in disease activity

    Difference between the intervention and control group in the changes in Disease Activity (using DAS28 score: greater than 2,6 implies active disease), from baseline to the end of follow-up

    15 weeks

  • Changes in Quality of Life

    Difference between the intervention and control group in changes in Quality of Life (Health Assessment Questionnaire (HAQ): scores of 0 to 1 are generally considered to represent mild to moderate difficulty, 1 to 2 moderate to severe disability, and 2 to 3 severe to very severe disability), from baseline to the end of follow-up

    15 weeks

Secondary Outcomes (7)

  • Changes in C-Reactive Protein (CRP)

    15 weeks

  • Changes in Erythrocyte Sedimentation Rate (ESR)

    15 weeks

  • Changes in Rheumatoid Factor (RF)

    15 weeks

  • Changes in Gut microbiota

    15 weeks

  • Changes in weight

    15 weeks

  • +2 more secondary outcomes

Study Arms (2)

Diet Control

OTHER

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.

Other: Diet Control

Diet Anti-inflammatory

EXPERIMENTAL

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.

Other: Diet anti-inflammatory

Interventions

Diet ControlOTHER

Diet following mediterranean principles, for 15 weeks

Diet Control
Diet anti-inflammatoryOTHER

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.

Diet Anti-inflammatory

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Particular do Algarve - HPA Saúde

Portimão, Portugal

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ana Faria, PhD

    Universidade Nova de Lisboa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 20, 2022

Study Start

April 1, 2021

Primary Completion

December 20, 2021

Study Completion

December 20, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations

PT(1)