Omega-3 and Exercise in Rheumatoid Arthritis People
NCT05945693 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2023-07-14
Summary
Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by autoantibody production and synovial membrane damage. It significantly impairs overall function and quality of life. Consumption of omega-3 (n-3) polyunsaturated fatty acids (PUFAs) and regular aerobic exercise (AEx) training are reported to have positive effects on the progression of RA. However, the mechanisms behind these benefits are still inconclusive. This study aims to investigate the effects of n-3 PUFA supplementation and AEx training on disease progression, cardiometabolic health, and quality of life, and their association with the plasma and synovial fluid levels of specialized pro-resolving mediators (SPMs) in subjects with RA. The study consists of a 16-week intervention period, during which participants will be randomly assigned in a double-blinded manner to one of four groups: placebo control (PLA), PLA+AEx, n-3, or n-3+AEx. The PLA groups will be given a gelatin-filled capsule, while the n-3 groups will be given n-3 PUFAs equivalent to 2.5 g/d of docosahexaenoic acid and 0.5 g/d of eicosapentaenoic acid. The AEx groups will exercise thrice per week on a stationary electronically braked cycle ergometer at 60-70% of their VO2peak for 50-60 minutes. Before and after the intervention, participants will undergo RA-specific and functional measurements, peak aerobic capacity test, and a dietary and physical activity assessment. Venous blood and synovial fluid from the knee joint will be collected. Changes in disease progression, cardiometabolic health, quality of life, and erythrocyte membrane composition to assess n-3 incorporation, SPM levels, inflammatory markers, and gene expression from blood and synovial fluid will be analyzed. The study aims to elucidate the SPMs that regulate the inflammatory gene expression pathways and associate them with improvements in disease progression, cardiometabolic health, and quality of life after n-3 PUFA supplementation and AEx training.
Conditions
- Arthritis, Rheumatoid
Interventions
- DIETARY_SUPPLEMENT
-
Placebo
The participants will be supplemented with 5 capsules per day of a placebo-filled gelatin capsule for 16 weeks.
- DIETARY_SUPPLEMENT
-
Omega-3
The participants will be supplemented with 5 capsules per day of Omega UP (Newscience, Chile) equivalent to 2.5 g/d of DHA and 0.5 g/d of EPA for 16 weeks.
- DIETARY_SUPPLEMENT
-
Aerobic exercise
The participants will perform aerobic-type exercise training three times per week, on non-consecutive days, with a total time of 20-60 minutes per day for 16 weeks.
Sponsors & Collaborators
-
Universidad Nacional Andres Bello
collaborator OTHER -
University of Manitoba
collaborator OTHER -
University of Guelph
collaborator OTHER -
University of Chile
collaborator OTHER -
Instituto de Ciencias de la Salud, Universidad de O'Higgins
lead OTHER
Principal Investigators
-
Sebastian Jannas-Vela, PhD · Universidad de O'Higgins
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-15
- Primary Completion
- 2024-12-31
- Completion
- 2025-03-31
Countries
- Chile
Study Locations
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