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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Fiber diet
Protein diet
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Diet, Inflammation, Metabolomics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Gothenburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fiber diet

Protein diet

Arm Description

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

50% of daily intake, 5 days a week, a diet rich in protein, red meat and saturated fat will be provided to study subjects

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2016
Last Updated
March 1, 2019
Sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02941055
Brief Title
ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)
Acronym
ADIRA
Official Title
ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
May 9, 2018 (Actual)
Study Completion Date
May 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Diet, Inflammation, Metabolomics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fiber diet
Arm Type
Experimental
Arm Description
50% of daily intake, 5 days a week, a diet rich in fiber, fish and probiotics will be provided to study subjects
Arm Title
Protein diet
Arm Type
Active Comparator
Arm Description
50% of daily intake, 5 days a week, a diet rich in protein, red meat and saturated fat will be provided to study subjects
Intervention Type
Other
Intervention Name(s)
Fiber diet
Intervention Description
Foods will be delivered with a home delivery chain once a week for 10 wks of each diet
Intervention Type
Other
Intervention Name(s)
Protein diet
Intervention Description
Foods will be delivered with a home delivery chain once a week for 10 wks of each diet
Primary Outcome Measure Information:
Title
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
Description
Measured clinically
Time Frame
10 weeks of each diet
Secondary Outcome Measure Information:
Title
Difference in SF-36 between the two diet interventions, within each person
Description
Measured by validated instruments
Time Frame
10 weeks on each diet
Title
Difference and changes in metabolites between the two diet interventions, within each person
Description
Metabolomics with NMR and MS analyses of serum and urine samples
Time Frame
10 weeks on each diet
Title
Differences in inflammatory markers between the two diet interventions, within each person
Description
hs-CRP, cytokines in blood
Time Frame
10 weeks on each diet
Title
Difference in EQ5D between the two diet interventions, within each person
Description
Measured by validated instruments
Time Frame
10 weeks on each diet
Title
Difference in HAQ between the two diet interventions, within each person
Description
Measured by validated instruments
Time Frame
10 weeks on each diet
Other Pre-specified Outcome Measures:
Title
Cost effectiveness of study intervention by Health-related quality of life
Description
Health-related quality of life
Time Frame
10 weeks on each diet
Title
Cost effectiveness of study intervention by QALYs
Description
Quality-adjusted life years (QALYs)
Time Frame
10 weeks on each diet
Title
Changes in blood lipids between the two diet interventions, within each person
Description
TAG, LDL, HDL etc
Time Frame
10 weeks on each diet
Title
Effects of genetic polymorphisms in dietary response
Description
Genetic analyses
Time Frame
10 weeks on each diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Winkvist, PhD
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Gothenburg
City
Göteborg
ZIP/Postal Code
40530
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not approved by the Ethical Review board
Citations:
PubMed Identifier
29678183
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.
Results Reference
background
PubMed Identifier
30340316
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.
Results Reference
result
PubMed Identifier
35799579
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.
Results Reference
derived
PubMed Identifier
33485336
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.
Results Reference
derived
PubMed Identifier
32055820
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.
Results Reference
derived

Learn more about this trial

ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)

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