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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: Fiber diet; Other: Protein diet

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Göteborg, Sweden, 40530
    • The University of Gothenburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measured clinically	10 weeks of each diet

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in SF-36 between the two diet interventions, within each person	Measured by validated instruments	10 weeks on each diet
Difference and changes in metabolites between the two diet interventions, within each person	Metabolomics with NMR and MS analyses of serum and urine samples	10 weeks on each diet
Differences in inflammatory markers between the two diet interventions, within each person	hs-CRP, cytokines in blood	10 weeks on each diet
Difference in EQ5D between the two diet interventions, within each person	Measured by validated instruments	10 weeks on each diet
Difference in HAQ between the two diet interventions, within each person	Measured by validated instruments	10 weeks on each diet

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost effectiveness of study intervention by Health-related quality of life	Health-related quality of life	10 weeks on each diet
Cost effectiveness of study intervention by QALYs	Quality-adjusted life years (QALYs)	10 weeks on each diet
Changes in blood lipids between the two diet interventions, within each person	TAG, LDL, HDL etc	10 weeks on each diet
Effects of genetic polymorphisms in dietary response	Genetic analyses	10 weeks on each diet

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Anna Winkvist, PhD, Göteborg University

Publications and helpful links

General Publications

• Winkvist A, Barebring L, Gjertsson I, Ellegard L, Lindqvist HM. A randomized controlled cross-over trial investigating the effect of anti-inflammatory diet on disease activity and quality of life in rheumatoid arthritis: the Anti-inflammatory Diet In Rheumatoid Arthritis (ADIRA) study protocol. Nutr J. 2018 Apr 20;17(1):44. doi: 10.1186/s12937-018-0354-x.
• Barebring L, Winkvist A, Gjertsson I, Lindqvist HM. Poor Dietary Quality Is Associated with Increased Inflammation in Swedish Patients with Rheumatoid Arthritis. Nutrients. 2018 Oct 18;10(10):1535. doi: 10.3390/nu10101535.
• Turesson Wadell A, Barebring L, Hulander E, Gjertsson I, Lindqvist HM, Winkvist A. Inadequate Dietary Nutrient Intake in Patients With Rheumatoid Arthritis in Southwestern Sweden: A Cross-Sectional Study. Front Nutr. 2022 Jun 21;9:915064. doi: 10.3389/fnut.2022.915064. eCollection 2022.
• Hulander E, Barebring L, Turesson Wadell A, Gjertsson I, Calder PC, Winkvist A, Lindqvist HM. Diet intervention improves cardiovascular profile in patients with rheumatoid arthritis: results from the randomized controlled cross-over trial ADIRA. Nutr J. 2021 Jan 23;20(1):9. doi: 10.1186/s12937-021-00663-y.
• Vadell AKE, Barebring L, Hulander E, Gjertsson I, Lindqvist HM, Winkvist A. Anti-inflammatory Diet In Rheumatoid Arthritis (ADIRA)-a randomized, controlled crossover trial indicating effects on disease activity. Am J Clin Nutr. 2020 Jun 1;111(6):1203-1213. doi: 10.1093/ajcn/nqaa019.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): May 9, 2018
• Study Completion (Actual): May 9, 2018

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (Estimated): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Inflammation; Metabolomics; Diet
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ADIRA2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not approved by the Ethical Review board

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No