Omega-3 and Exercise in Rheumatoid Arthritis People
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ClinicalTrials.gov Identifier: NCT05945693 |
Recruitment Status :
Active, not recruiting
First Posted : July 14, 2023
Last Update Posted : July 14, 2023
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Condition or disease | Intervention/treatment | Phase |
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Arthritis, Rheumatoid | Dietary Supplement: Placebo Dietary Supplement: Omega-3 Dietary Supplement: Aerobic exercise | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 88 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Supportive Care |
Official Title: | Role of Specialized Pro-resolving Mediators on Inflammation, Cardiometabolic Health, Disease Progression, and Quality of Life in Patients With Rheumatoid Arthritis After Omega-3 PUFA Supplementation and Aerobic Exercise Training. |
Actual Study Start Date : | March 15, 2022 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | March 2025 |
Arm | Intervention/treatment |
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Placebo Comparator: Placebo control
The participants will be supplemented with 5 capsules per day of a placebo-filled gelatin capsule.
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Dietary Supplement: Placebo
The participants will be supplemented with 5 capsules per day of a placebo-filled gelatin capsule for 16 weeks. |
Active Comparator: Placebo and aerobic exercise
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.
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Dietary Supplement: Placebo
The participants will be supplemented with 5 capsules per day of a placebo-filled gelatin capsule 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. |
Experimental: 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.
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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. |
Experimental: Omega-3 and aerobic exercise
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.
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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. |
- Early morning stiffness [ Time Frame: Pre and post intervention (16 weeks) ]Duration of morning stiffness in minutes
- Disease activity score-28 [ Time Frame: Pre and post intervention (16 weeks) ]Severity of rheumatoid arthritis using clinical and laboratory data
- Health assessment questionnaire disability index [ Time Frame: Pre and post intervention (16 weeks) ]Questionnaire that evaluates the functional status of individuals with rheumatoid arthritis
- Quality of life RA [ Time Frame: Pre and post intervention (16 weeks) ]8-item RA-specific health-related quality of life instrument scale.
- Analgesic use [ Time Frame: Pre and post intervention (16 weeks) ]Pill counts for paracetamol and NSAIDs
- Timed Up and Go test [ Time Frame: Pre and post intervention (16 weeks) ]The participant starts in a seated position, stands up upon command, walks 3 meters, turns around, walks back to the chair, and sits down. The time stops when the subject is seated
- Short Physical Performance Battery [ Time Frame: Pre and post intervention (16 weeks) ]Evaluates lower extremity functional performance using timed measures of standing balance, a 4-meter walk, and five repetitive chair stands
- Handgrip strength [ Time Frame: Pre and post intervention (16 weeks) ]Measures the maximum isometric strength of the hand and forearm muscles.
- Peak aerobic capacity [ Time Frame: Pre and post intervention (16 weeks) ]Incremental cycling test to exhaustion using a recumbent cycle ergometer to measure aerobic capacity.
- Dietary assessment [ Time Frame: Pre and post intervention (16 weeks) ]Dietary record using image-assisted method over three days (two consecutive weekdays and one weekend day)
- Global Physical Activity Questionnaire [ Time Frame: Pre and post intervention (16 weeks) ]Questionnaire to assess physical activity levels
- Plasma rheumatoid factor [ Time Frame: Pre and post intervention (16 weeks) ]Plasma rheumatoid factor will be measured via commercial ELISA assay kits.
- Total cholesterol [ Time Frame: Pre and post intervention (16 weeks) ]Total cholesterol will be measured.
- LDL cholesterol [ Time Frame: Pre and post intervention (16 weeks) ]LDL cholesterol will be measured.
- HDL cholesterol [ Time Frame: Pre and post intervention (16 weeks) ]HDL cholesterol will be measured.
- TNF-alfa [ Time Frame: Pre and post intervention (16 weeks) ]Plasma TNF-alfa will be measured via commercial ELISA assay kits.
- IL-10 [ Time Frame: Pre and post intervention (16 weeks) ]Plasma IL-10 will be measured via commercial ELISA assay kits.
- Gene expression [ Time Frame: Pre and post intervention (16 weeks) ]Real-time PCR will be carried out to quantify the changes in the expression of genes associated with inflammatory pathways and oxylipin synthesis
- Phospholipid fatty acid composition [ Time Frame: Pre and post intervention (16 weeks) ]Quantitative extraction of total lipids from erythrocytes, plasma, and synovial fluid will be carried out.
- Oxylipin analyses [ Time Frame: Pre and post intervention (16 weeks) ]Plasma and synovial fluid samples will be analyzed in duplicate for oxylipins by HPLC/MS/MS.
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05945693
Chile | |
Universidad de O'Higgins | |
Rancagua, Libertador Bernardo O'Higgins, Chile, 2820000 |
Principal Investigator: | Sebastian Jannas-Vela, PhD | Universidad de O'Higgins |
Responsible Party: | Sebastian Jannas-Vela, Assistant Professor, Instituto de Ciencias de la Salud, Universidad de O'Higgins |
ClinicalTrials.gov Identifier: | NCT05945693 |
Other Study ID Numbers: |
11220333 |
First Posted: | July 14, 2023 Key Record Dates |
Last Update Posted: | July 14, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
omega-3 exercise oxylipins |
specialized pro-resolving mediators inflammation gene expression |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |