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NCT Number: NCT05336513

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Particular do Algarve - HPA Saúde

Portimão, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet Control

Other

Diet following mediterranean principles, for 15 weeks

Diet anti-inflammatory

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.

Primary outcomes

  1. Changes in disease activity

    Time frame: 15 weeks

    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

  2. Changes in Quality of Life

    Time frame: 15 weeks

    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

Secondary outcomes

  1. Changes in C-Reactive Protein (CRP)

    Time frame: 15 weeks

    Difference between the intervention and control group in changes in C-Reactive Protein (CRP) measured in mg/L, from baseline to the end of follow-up

  2. Changes in Erythrocyte Sedimentation Rate (ESR)

    Time frame: 15 weeks

    Difference between the intervention and control group in changes in Erythrocyte Sedimentation Rate (ESR) measured in mm/h, from baseline to the end of follow-up

  3. Changes in Rheumatoid Factor (RF)

    Time frame: 15 weeks

    Difference between the intervention and control group changes in Rheumatoid Factor (RF) measured in IU/mL, from baseline to the end of follow-up

  4. Changes in Gut microbiota

    Time frame: 15 weeks

    Difference between the intervention and control group in the change of gut microbiota from baseline to the end of follow-up.

    Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage.

  5. Changes in weight

    Time frame: 15 weeks

    Difference between the intervention and control group changes in weight, measured in Kg, from baseline to the end of follow-up

  6. Changes in Body Mass Index (BMI)

    Time frame: 15 weeks

    Difference between the intervention and control group changes in BMI, calculated using weight and height, presented in kg/m2: underweight < 18,5; normoweight 18,6-24,9; overweight 25-29,9; obese >30, from baseline to the end of follow-up

  7. Changes in waist circumference perimeter

    Time frame: 15 weeks

    Difference between the intervention and control group changes in waist circumference perimeter, measured in cm, from baseline to the end of follow-up

Sponsors and collaborators

Lead sponsor

Universidade Nova de Lisboa

Other

Collaborators

  • Hospital Particular do Algarve - HPA Saúde

Registry information

Official study 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

Acronym: DAIAR

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2022
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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