ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)

Rheumatoid Arthritis Clinical Trial

— ADIRA  

Official title:

ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941055
• Other study ID #: ADIRA2016
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: May 9, 2018

Study information

• Verified date: March 2019
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 9, 2018
• Est. primary completion date: May 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Fiber diet
Foods will be delivered with a home delivery chain once a week for 10 wks of each diet
• Protein diet
Foods will be delivered with a home delivery chain once a week for 10 wks of each diet

Locations

Country	Name	City	State
Sweden	The University of Gothenburg	Göteborg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Bärebring 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). pii: E1535. doi: 10.3390/nu10101535. — View Citation

Winkvist A, Bärebring L, Gjertsson I, Ellegård 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost effectiveness of study intervention by Health-related quality of life	Health-related quality of life	10 weeks on each diet
Other	Cost effectiveness of study intervention by QALYs	Quality-adjusted life years (QALYs)	10 weeks on each diet
Other	Changes in blood lipids between the two diet interventions, within each person	TAG, LDL, HDL etc	10 weeks on each diet
Other	Effects of genetic polymorphisms in dietary response	Genetic analyses	10 weeks on each diet
Primary	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	Difference in SF-36 between the two diet interventions, within each person	Measured by validated instruments	10 weeks on each diet
Secondary	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
Secondary	Differences in inflammatory markers between the two diet interventions, within each person	hs-CRP, cytokines in blood	10 weeks on each diet
Secondary	Difference in EQ5D between the two diet interventions, within each person	Measured by validated instruments	10 weeks on each diet
Secondary	Difference in HAQ between the two diet interventions, within each person	Measured by validated instruments	10 weeks on each diet