ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)

NCT02941055 | Completed

• 1 other identifier: ADIRA2016
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Diet; Inflammation; Metabolomics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Difference in SF-36 between the two diet interventions, within each person

  10 weeks on each diet

• Difference and changes in metabolites between the two diet interventions, within each person

  10 weeks on each diet

• Differences in inflammatory markers between the two diet interventions, within each person

  10 weeks on each diet

• Difference in EQ5D between the two diet interventions, within each person

  10 weeks on each diet

• Difference in HAQ between the two diet interventions, within each person

  10 weeks on each diet

Other Outcomes (4)

• Cost effectiveness of study intervention by Health-related quality of life

  10 weeks on each diet

• Cost effectiveness of study intervention by QALYs

  10 weeks on each diet

• Changes in blood lipids between the two diet interventions, within each person

  10 weeks on each diet

Study Arms (2)

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

Other: Fiber diet

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

Other: Protein diet

Interventions

Fiber diet OTHER

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

Fiber diet

Protein diet OTHER

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

Protein diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Other life threatening diseases, pregnancy, lactation, food intolerance or allergy to food included in the trial, ability to understand information in Swedish

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

The University of Gothenburg

Gothenburg, 40530, Sweden

Location

Related Publications (6)

• 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.

  PMID: 29678183 BACKGROUND

• 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.

  PMID: 30340316 RESULT

• 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.

  PMID: 37426179 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.

  PMID: 35799579 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.

  PMID: 33485336 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.

  PMID: 32055820 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Inflammation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna Winkvist, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 21, 2016
• Study Start: February 1, 2017
• Primary Completion: May 9, 2018
• Study Completion: May 9, 2018
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)