ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-05-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mussels, Inflammation and Rheumatoid Arthritis (MIRA)

NCT02522052

Rheumatoid Arthritis

COMPLETED NA

Anti-Inflammatory Dietary Intervention for Rheumatoid Arthritis

NCT05291299

Rheumatoid Arthritis

UNKNOWN NA

Rheumatism and Dietetic: RHUMADIET Study (Food Practices and Beliefs)

NCT03770884

Rheumatoid Arthritis Axial Spondyloarthritis Hand Osteoarthritis

COMPLETED

Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers

NCT01029613

Rheumatoid Arthritis

COMPLETED

An MRI-guided Treatment Strategy to Prevent Disease Progression in Patients With Rheumatoid Arthritis

NCT01656278

Arthritis Arthritis, Rheumatoid Joint Diseases +4 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fiber diet

50% of daily intake, 5 days a week, a diet rich in fiber, fish and probiotics will be provided to study subjects

Group Type EXPERIMENTAL

Fiber diet

Intervention Type OTHER

Foods will be delivered with a home delivery chain once a week for 10 wks of each diet

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

Group Type ACTIVE_COMPARATOR

Protein diet

Intervention Type OTHER

Foods will be delivered with a home delivery chain once a week for 10 wks of each diet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fiber diet

Foods will be delivered with a home delivery chain once a week for 10 wks of each diet

Intervention Type OTHER

Protein diet

Foods will be delivered with a home delivery chain once a week for 10 wks of each diet

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No