Clinical trial NCT02941055: ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)
Official title: ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Diet
Inflammation
Metabolomics
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2016-10-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 10 weeks of each diet
Secondary outcomes:
measure: Difference in SF-36 between the two diet interventions, within each person
timeFrame: 10 weeks on each diet
measure: Difference and changes in metabolites between the two diet interventions, within each person
timeFrame: 10 weeks on each diet
measure: Differences in inflammatory markers between the two diet interventions, within each person
timeFrame: 10 weeks on each diet
measure: Difference in EQ5D between the two diet interventions, within each person
timeFrame: 10 weeks on each diet
measure: Difference in HAQ between the two diet interventions, within each person
timeFrame: 10 weeks on each diet
Other outcomes:
measure: Cost effectiveness of study intervention by Health-related quality of life
timeFrame: 10 weeks on each diet
measure: Cost effectiveness of study intervention by QALYs
timeFrame: 10 weeks on each diet
measure: Changes in blood lipids between the two diet interventions, within each person
timeFrame: 10 weeks on each diet
measure: Effects of genetic polymorphisms in dietary response
timeFrame: 10 weeks on each diet
Locations:
city: Göteborg
country: Sweden
facility: The University of Gothenburg
Study officials:
affiliation: Göteborg University
name: Anna Winkvist, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.