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NCT Number: NCT02941055

ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)

Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects 0.5-1% of the population, and where many patients in spite of modern pharmacological treatment fail to reach remission. The main goal of the randomized cross-over trial ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis) is to test the hypothesis that a diet intervention will decrease disease activity and improve quality of life in patients with established RA.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Gothenburg

Gothenburg, 40530, Sweden

About this study

Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects 0.5-1% of the population, and where many patients in spite of modern pharmacological treatment fail to reach remission. This affects physical as well as mental wellbeing and leads to severely reduced quality of life and reduced work capacity, thus yielding high individual as well as societal costs. To optimize treatment, alternatives such as diet should be evaluated as complement to pharmacological treatment. The main goal of the randomized cross-over trial ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis) is to test the hypothesis that a diet intervention will decrease disease activity and costs and improve quality of life in patients with established RA. In total, 60 RA patients with moderate disease activity will be randomized to receive initially either a portfolio diet based on several food items with suggested anti-inflammatory effects or a control diet (western type), during 2 x 10 wks with a 3 months wash-out between diets. Both groups continue with regular pharmacological treatment. Known food biomarkers will be analyzed to measure intervention compliance. Impact on disease activity (measured by DAS28, a composite score which predicts disability and progression of RA) and quality of life is evaluated after each diet regimen. Metabolomics will be used to evaluate the potential to predict responders to dietary treatment. ADIRA will provide evidence whether dietary treatment of RA leads to more patients reaching remission and improved quality of life and work capacity as well as reduce individual and societal costs. Scientific evidence exists for anti-inflammatory effect by single foods on RA, but no study exists where these foods have been combined to obtain maximum effect and thus have the potential to offer a substantial improvement in patient life quality. Such evidence has been asked for by RA patents as well as by treating physicians.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with established RA, disease duration >2 years, disease activity DAS28 >= 2.6 and a disease that is clinically stable and under adequate control and medication, will be invited to participate.

Exclusion criteria

  • Other life threatening diseases, pregnancy, lactation, food intolerance or allergy to food included in the trial, ability to understand information in Swedish

Treatment and study plan

Fiber diet

Other

Foods will be delivered with a home delivery chain once a week for 10 wks of each diet

Protein Diet

Other

Foods will be delivered with a home delivery chain once a week for 10 wks of each diet

Primary outcomes

  1. Difference in disease activity score DAS28 (ie a composite score including tender and swollen joints count, ESR or CRP, VAS scale global health) between the two diet interventions, within each person

    Time frame: 10 weeks of each diet

    Measured clinically

Secondary outcomes

  1. Difference in SF-36 between the two diet interventions, within each person

    Time frame: 10 weeks on each diet

    Measured by validated instruments

  2. Difference and changes in metabolites between the two diet interventions, within each person

    Time frame: 10 weeks on each diet

    Metabolomics with NMR and MS analyses of serum and urine samples

  3. Differences in inflammatory markers between the two diet interventions, within each person

    Time frame: 10 weeks on each diet

    hs-CRP, cytokines in blood

  4. Difference in EQ5D between the two diet interventions, within each person

    Time frame: 10 weeks on each diet

    Measured by validated instruments

  5. Difference in HAQ between the two diet interventions, within each person

    Time frame: 10 weeks on each diet

    Measured by validated instruments

Other outcomes

  1. Cost effectiveness of study intervention by Health-related quality of life

    Time frame: 10 weeks on each diet

    Health-related quality of life

  2. Cost effectiveness of study intervention by QALYs

    Time frame: 10 weeks on each diet

    Quality-adjusted life years (QALYs)

  3. Changes in blood lipids between the two diet interventions, within each person

    Time frame: 10 weeks on each diet

    TAG, LDL, HDL etc

  4. Effects of genetic polymorphisms in dietary response

    Time frame: 10 weeks on each diet

    Genetic analyses

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Sahlgrenska University Hospital

Registry information

Acronym: ADIRA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 21, 2016
Registry last updated
Oct 15, 2024

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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