Omega-3 and Exercise in Rheumatoid Arthritis People

NCT05945693 | Unknown DMC

• 1 other identifier: 11220333
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

omega-3; exercise; oxylipins; specialized pro-resolving mediators; inflammation; gene expression

Outcome Measures

Primary Outcomes (1)

• Early morning stiffness

  Duration of morning stiffness in minutes

  Pre and post intervention (16 weeks)

Secondary Outcomes (19)

• Disease activity score-28

  Pre and post intervention (16 weeks)

• Health assessment questionnaire disability index

  Pre and post intervention (16 weeks)

• Quality of life RA

  Pre and post intervention (16 weeks)

• Analgesic use

  Pre and post intervention (16 weeks)

• Timed Up and Go test

  Pre and post intervention (16 weeks)

Study Arms (4)

Placebo control

PLACEBO COMPARATOR

The participants will be supplemented with 5 capsules per day of a placebo-filled gelatin capsule.

Dietary Supplement: Placebo

Placebo and aerobic exercise

ACTIVE COMPARATOR

The participants will be supplemented with 5 capsules per day of a placebo-filled gelatin capsule and will perform aerobic type exercise training three times per week, on non-consecutive days, with a total time of 20-60 minutes per day.

Dietary Supplement: Placebo; Dietary Supplement: Aerobic exercise

Omega-3

EXPERIMENTAL

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.

Dietary Supplement: Omega-3

Omega-3 and aerobic exercise

EXPERIMENTAL

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 and will perform aerobic type exercise training three times per week, on non-consecutive days, with a total time of 20-60 minutes per day.

Dietary Supplement: Omega-3; Dietary Supplement: Aerobic exercise

Interventions

Placebo DIETARY_SUPPLEMENT

The participants will be supplemented with 5 capsules per day of a placebo-filled gelatin capsule for 16 weeks.

Placebo and aerobic exercise; Placebo control

Omega-3 DIETARY_SUPPLEMENT

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.

Omega-3; Omega-3 and aerobic exercise

Aerobic exercise DIETARY_SUPPLEMENT

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.

Omega-3 and aerobic exercise; Placebo and aerobic exercise

Eligibility Criteria

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

You may qualify if:

• Patients with rheumatoid arthritis with moderate disease activity as defined by the Disease Activity Score 28 (DAS28) \> 2.6 and \< 5.1.
• Participants taking nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, or disease-modifying anti-rheumatic drugs (DMARDs) will be eligible; however, the dosages of these agents must be constant at least four weeks before, must remain within this limit throughout the study, and prednisone dose should not be higher than 7.5 mg/d

You may not qualify if:

• Individuals diagnosed with gastrointestinal or metabolic diseases, regular alcohol abuse, smokers, and dietary supplement intake (e.g., fish oil capsules) or consumption of fish \> 2 times per week.
• Individuals that perform regular aerobic exercise (\> 150 min moderate intensity per week) or have any physical or biomechanical limitations to complete the exercise program
• Individuals that present blood levels of aspartate aminotransferase, alanine transaminase, or creatinine higher than 1.5 times the maximum normal limit and total bilirubin levels of more than 1.8 mg/dL

Sponsors & Collaborators

• Instituto de Ciencias de la Salud, Universidad de O'Higgins: lead
• Universidad Nacional Andres Bello: collaborator
• University of Manitoba: collaborator
• University of Guelph: collaborator
• University of Chile: collaborator

Study Sites (1)

Universidad de O'Higgins

Rancagua, Libertador Bernardo O'Higgins, 2820000, Chile

Location

Related Publications (1)

• Jannas-Vela S, Candia AA, Penailillo L, Barrios-Troncoso P, Zapata-Urzua J, Rey-Puente J, Aukema HM, Mutch DM, Valenzuela R, Valladares-Ide D. Role of specialized pro-resolving mediators on inflammation, cardiometabolic health, disease progression, and quality of life after omega-3 PUFA supplementation and aerobic exercise training in individuals with rheumatoid arthritis: a randomized 16-week, placebo-controlled interventional trial. F1000Res. 2023 Aug 7;12:942. doi: 10.12688/f1000research.138392.1. eCollection 2023.

  PMID: 38778807 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Motor Activity; Inflammation

Interventions

Docosahexaenoic Acids; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sebastian Jannas-Vela, PhD

  Universidad de O'Higgins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The masking process will ensure that both the participants and the investigators involved in the study remain unaware of the treatment assignments throughout the entire duration of the study. A unique identification code will be assigned to each participant upon enrollment, which conceals their treatment allocation. The allocation sequence will be generated by a person not directly involved in the study. The capsules in the experimental intervention and the control treatment, will be packaged identically to maintain visual similarity. The packaging materials and labeling will be designed to be indistinguishable between the two groups. In addition, all outcome assessments and data collection procedures will be performed by personnel who are blinded to the treatments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study consists of a 16-week intervention with omega-3 polyunsaturated fatty acids (n-3 PUFAs) and/or aerobic exercise (AEx) training. The subjects 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 training sessions will be conducted at the Laboratorio de Ciencias del Ejercicio en el Ciclo Vital (Lab-CERVITAL), Universidad de O'Higgins. The week before intervention the participants will perform RA-specific tests (e.g., Disease Activity Score-28) and functional measurements (e.g., handgrip strength), peak aerobic capacity test, a dietary and physical activity assessment, and blood samples will be collected. Subsequently, participants will start their 16-week intervention (PLA, PLA+AEx, n-3, or n-3+AEx). At the end of the intervention the same initial measurements, questionnaires, and assessments will be collected.

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 14, 2023
• Study Start: March 15, 2022
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)