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ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis) (ADIRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02941055
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Göteborg University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Fiber diet Other: Protein diet Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : May 9, 2018
Actual Study Completion Date : May 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fiber diet
50% of daily intake, 5 days a week, a diet rich in fiber, fish and probiotics will be provided to study subjects
Other: Fiber diet
Foods will be delivered with a home delivery chain once a week for 10 wks of each diet

Active Comparator: Protein diet
50% of daily intake, 5 days a week, a diet rich in protein, red meat and saturated fat will be provided to study subjects
Other: Protein diet
Foods will be delivered with a home delivery chain once a week for 10 wks of each diet




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941055


Locations
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Sweden
The University of Gothenburg
Göteborg, Sweden, 40530
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Anna Winkvist, PhD Göteborg University
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02941055    
Other Study ID Numbers: ADIRA2016
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not approved by the Ethical Review board

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Göteborg University:
Diet
Inflammation
Metabolomics
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases