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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiber diet | Experimental | 50% of daily intake, 5 days a week, a diet rich in fiber, fish and probiotics will be provided to study subjects |
|
| Protein diet | Active Comparator | 50% of daily intake, 5 days a week, a diet rich in protein, red meat and saturated fat will be provided to study subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiber diet | Other | Foods will be delivered with a home delivery chain once a week for 10 wks of each diet |
|
| 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 |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Winkvist, PhD | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Gothenburg | Gothenburg | 40530 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29678183 | Background | 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. | |
| 30340316 |
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Not approved by the Ethical Review board
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Protein diet | Other | Foods will be delivered with a home delivery chain once a week for 10 wks of each diet |
|
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 |
| 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 |
| 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. |
| 37426179 | Derived | Wadell AT, Barebring L, Hulander E, Gjertsson I, Landberg R, Lindqvist H, Winkvist A. Dietary biomarkers and food records indicate compliance to study diets in the ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis) trial. Front Nutr. 2023 Jun 22;10:1209787. doi: 10.3389/fnut.2023.1209787. eCollection 2023. |
| 35799579 | Derived | 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. |
| 33485336 | Derived | 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. |
| 32055820 | Derived | 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. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |