Arthritis, RheumatoidNCT05945693
Omega-3 and Exercise in Rheumatoid Arthritis People
A study testing Omega-3 and Aerobic exercise in people with Arthritis, Rheumatoid, run by Instituto de Ciencias de la Salud, Universidad de O'Higgins at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Omega-3 and Aerobic exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteChile
- Study dates
- 15 Mar 2022to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site
Universidad de O'Higgins
Rancagua, Libertador Bernardo O'Higgins, 2820000
About this study
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.
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.
Read the detailed description
Research hypothesis: N-3 PUFA and AEx will have synergistic effects on disease progression, cardiometabolic health, and quality of life in individuals with RA, and these changes will be associated with SPM production in blood and synovial fluid.
General aim: 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 SPMs in individuals with RA.
Specific aims:
- To compare the effects of n-3 PUFA supplementation, AEx training, and the combination of both on disease progression, cardiometabolic health, and quality of life in individuals with RA.
- To compare the effects of n-3 PUFA supplementation, AEx, and the combination of both on the plasma and synovial fluid levels of the SPMs in individuals with RA.
- To examine the relationship between the plasma levels of the n-3 PUFA derived SPMs with systemic disease progression, cardiometabolic health, and quality of life in individuals with RA
Study design 88 Participants will be recruited from hospitals and private clinics in the central region of Chile, whereas all the interventions regarding AEx will be carried out at the Universidad de O'Higgins and the Hospital Regional de Rancagua. All institutions are in the Región del Libertador Bernardo O'Higgins, Chile. This study consists of a 16-week intervention with 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. A stratified randomized assignment (by block) process will be employed to ensure that the experimental groups are balanced for disease activity, pharmacological treatment, sex, and age. 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. In a subgroup of participants (n=24 in total or n=6 per group) extraction of synovial fluid will be performed before and after the intervention.
The participants will be supplemented with either 5 capsules per day of Omega UP (Newscience, Chile) equivalent to 2.5 g/d of DHA and 0.5 g/d of EPA or a placebo filled gelatin capsule. The current doses are within the limits recommended by the European Food Safety Authority and have been shown to be safe, to be incorporated into cell membranes, and to produce significant improvements in overall health in individuals with RA. Capsules will be placed into de-identified bottles by people not involved in the study and provided to the participants to ensure double blinding. The exercise intervention will be performed according to the recommendations from the European Alliance of Associations for Rheumatology (EULAR) consisting of aerobic type exercise training three times per week, on non-consecutive days, with a total time of 20-60 minutes. The AEx will be performed on a stationary electronically braked cycle ergometer starting at 40-50% of VO2peak for 20 minutes. The intensity and volume of cycling will then be gradually increased to target at least 60-70% of VO2peak for 50-60 minutes over the final 10 weeks. Heart rate, power output and rating of perceived exertion (RPE) will be monitored during training intervention.
Statistical analysis Results will be expressed as mean ± SD. A two-way ANOVA with repeated measures followed by Fisher's least significant difference post-test for multiple comparisons between groups will be used. Linear regression models will be constructed to examine the association between SPMs and clinical, functional, and health parameters, accounting for participant age, sex, and BMI as covariates. A value of p<0.05 will be considered statistically significant.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Placebo, Omega-3, Aerobic exercise
- Keywords
- omega-3, exercise, oxylipins, specialized pro-resolving mediators, inflammation, gene expression
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
The participants will be supplemented with 5 capsules per day of a placebo-filled gelatin capsule for 16 weeks.
Omega-3Dietary 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.
Aerobic exerciseDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo control | Placebo comparator | The participants will be supplemented with 5 capsules per day of a placebo-filled gelatin capsule. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Omega-3; Dietary Supplement: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early morning stiffness
Duration of morning stiffness in minutes
Measured: Pre and post intervention (16 weeks)
Secondary outcomes (19)
Disease activity score-28
Severity of rheumatoid arthritis using clinical and laboratory data
Measured: Pre and post intervention (16 weeks)
Health assessment questionnaire disability index
Questionnaire that evaluates the functional status of individuals with rheumatoid arthritis
Measured: Pre and post intervention (16 weeks)
Quality of life RA
8-item RA-specific health-related quality of life instrument scale.
Measured: Pre and post intervention (16 weeks)
Analgesic use
Pill counts for paracetamol and NSAIDs
Measured: Pre and post intervention (16 weeks)
Timed Up and Go test
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
Measured: Pre and post intervention (16 weeks)
Short Physical Performance Battery
Evaluates lower extremity functional performance using timed measures of standing balance, a 4-meter walk, and five repetitive chair stands
Measured: Pre and post intervention (16 weeks)
Handgrip strength
Measures the maximum isometric strength of the hand and forearm muscles.
Measured: Pre and post intervention (16 weeks)
Peak aerobic capacity
Incremental cycling test to exhaustion using a recumbent cycle ergometer to measure aerobic capacity.
Measured: Pre and post intervention (16 weeks)
Dietary assessment
Dietary record using image-assisted method over three days (two consecutive weekdays and one weekend day)
Measured: Pre and post intervention (16 weeks)
Global Physical Activity Questionnaire
Questionnaire to assess physical activity levels
Measured: Pre and post intervention (16 weeks)
Plasma rheumatoid factor
Plasma rheumatoid factor will be measured via commercial ELISA assay kits.
Measured: Pre and post intervention (16 weeks)
Total cholesterol
Total cholesterol will be measured.
Measured: Pre and post intervention (16 weeks)
LDL cholesterol
LDL cholesterol will be measured.
Measured: Pre and post intervention (16 weeks)
HDL cholesterol
HDL cholesterol will be measured.
Measured: Pre and post intervention (16 weeks)
TNF-alfa
Plasma TNF-alfa will be measured via commercial ELISA assay kits.
Measured: Pre and post intervention (16 weeks)
IL-10
Plasma IL-10 will be measured via commercial ELISA assay kits.
Measured: Pre and post intervention (16 weeks)
Gene expression
Real-time PCR will be carried out to quantify the changes in the expression of genes associated with inflammatory pathways and oxylipin synthesis
Measured: Pre and post intervention (16 weeks)
Phospholipid fatty acid composition
Quantitative extraction of total lipids from erythrocytes, plasma, and synovial fluid will be carried out.
Measured: Pre and post intervention (16 weeks)
Oxylipin analyses
Plasma and synovial fluid samples will be analyzed in duplicate for oxylipins by HPLC/MS/MS.
Measured: Pre and post intervention (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start15 Mar 2022
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Ciencias de la Salud, Universidad de O'Higgins
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional Andres Bello, University of Manitoba, University of Guelph, University of Chile
- Responsible party
- Principal investigator, Sebastian Jannas-Vela, Instituto de Ciencias de la Salud, Universidad de O'Higgins
- Investigators
- Sebastian Jannas-Vela, PhD, Principal investigator, Universidad de O'Higgins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945693
- Sponsor's protocol ID
- 11220333
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38778807
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05945693
- Acronym / sponsor ID
- 11220333
- Conditions
- Arthritis, Rheumatoid
- Keywords
- omega-3, exercise, oxylipins, specialized pro-resolving mediators, inflammation, gene expression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Instituto de Ciencias de la Salud, Universidad de O'HigginsUniversity, hospital or other
- Collaborators
- Universidad Nacional Andres Bello, University of Manitoba, University of Guelph, University of Chile
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research hypothesis: N-3 PUFA and AEx will have synergistic effects on disease progression, cardiometabolic health, and quality of life in individuals with RA, and these changes will be associated with SPM production in blood and synovial fluid.
General aim: 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 SPMs in individuals with RA.
Specific aims:
- To compare the effects of n-3 PUFA supplementation, AEx training, and the combination of both on disease progression, cardiometabolic health, and quality of life in individuals with RA.
- To compare the effects of n-3 PUFA supplementation, AEx, and the combination of both on the plasma and synovial fluid levels of the SPMs in individuals with RA.
- To examine the relationship between the plasma levels of the n-3 PUFA derived SPMs with systemic disease progression, cardiometabolic health, and quality of life in individuals with RA
Study design 88 Participants will be recruited from hospitals and private clinics in the central region of Chile, whereas all the interventions regarding AEx will be carried out at the Universidad de O'Higgins and the Hospital Regional de Rancagua. All institutions are in the Región del Libertador Bernardo O'Higgins, Chile. This study consists of a 16-week intervention with 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. A stratified randomized assignment (by block) process will be employed to ensure that the experimental groups are balanced for disease activity, pharmacological treatment, sex, and age. 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. In a subgroup of participants (n=24 in total or n=6 per group) extraction of synovial fluid will be performed before and after the intervention.
The participants will be supplemented with either 5 capsules per day of Omega UP (Newscience, Chile) equivalent to 2.5 g/d of DHA and 0.5 g/d of EPA or a placebo filled gelatin capsule. The current doses are within the limits recommended by the European Food Safety Authority and have been shown to be safe, to be incorporated into cell membranes, and to produce significant improvements in overall health in individuals with RA. Capsules will be placed into de-identified bottles by people not involved in the study and provided to the participants to ensure double blinding. The exercise intervention will be performed according to the recommendations from the European Alliance of Associations for Rheumatology (EULAR) consisting of aerobic type exercise training three times per week, on non-consecutive days, with a total time of 20-60 minutes. The AEx will be performed on a stationary electronically braked cycle ergometer starting at 40-50% of VO2peak for 20 minutes. The intensity and volume of cycling will then be gradually increased to target at least 60-70% of VO2peak for 50-60 minutes over the final 10 weeks. Heart rate, power output and rating of perceived exertion (RPE) will be monitored during training intervention.
Statistical analysis Results will be expressed as mean ± SD. A two-way ANOVA with repeated measures followed by Fisher's least significant difference post-test for multiple comparisons between groups will be used. Linear regression models will be constructed to examine the association between SPMs and clinical, functional, and health parameters, accounting for participant age, sex, and BMI as covariates. A value of p<0.05 will be considered statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo control | Placebo comparator | Dietary Supplement: PlaceboThe participants will be supplemented with 5 capsules per day of a placebo-filled gelatin capsule. |
| Placebo and aerobic exercise | Active comparator | Dietary Supplement: Placebo, Dietary Supplement: Aerobic exerciseThe 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. |
| Omega-3 | Experimental | Dietary Supplement: Omega-3The 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. |
| Omega-3 and aerobic exercise | Experimental | Dietary Supplement: Omega-3, Dietary Supplement: Aerobic exerciseThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThe participants will be supplemented with 5 capsules per day of a placebo-filled gelatin capsule for 16 weeks. | Dietary supplement | Placebo and aerobic exercise, Placebo control |
| Omega-3The 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 | Omega-3, Omega-3 and aerobic exercise |
| Aerobic exerciseThe 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. | Dietary supplement | Omega-3 and aerobic exercise, Placebo and aerobic exercise |
Primary outcome
Early morning stiffness
Time frame: Pre and post intervention (16 weeks)
Duration of morning stiffness in minutes
19 secondary outcomes
Disease activity score-28
Time frame: Pre and post intervention (16 weeks)
Health assessment questionnaire disability index
Time frame: Pre and post intervention (16 weeks)
Quality of life RA
Time frame: Pre and post intervention (16 weeks)
Analgesic use
Time frame: Pre and post intervention (16 weeks)
Timed Up and Go test
Time frame: Pre and post intervention (16 weeks)
Short Physical Performance Battery
Time frame: Pre and post intervention (16 weeks)
Handgrip strength
Time frame: Pre and post intervention (16 weeks)
Peak aerobic capacity
Time frame: Pre and post intervention (16 weeks)
Dietary assessment
Time frame: Pre and post intervention (16 weeks)
Global Physical Activity Questionnaire
Time frame: Pre and post intervention (16 weeks)
Plasma rheumatoid factor
Time frame: Pre and post intervention (16 weeks)
Total cholesterol
Time frame: Pre and post intervention (16 weeks)
LDL cholesterol
Time frame: Pre and post intervention (16 weeks)
HDL cholesterol
Time frame: Pre and post intervention (16 weeks)
TNF-alfa
Time frame: Pre and post intervention (16 weeks)
IL-10
Time frame: Pre and post intervention (16 weeks)
Gene expression
Time frame: Pre and post intervention (16 weeks)
Phospholipid fatty acid composition
Time frame: Pre and post intervention (16 weeks)
Oxylipin analyses
Time frame: Pre and post intervention (16 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Derived from this study: PubMed 38778807Jannas-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Jannas-Vela, PhD principal investigator
Universidad de O'Higgins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 and Aerobic exercise in people with Arthritis, Rheumatoid, run by Instituto de Ciencias de la Salud, Universidad de O'Higgins at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early morning stiffness (time frame: Pre and post intervention (16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05945693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.