An interventional study of Fish oil supplementation and Sunflower seed oil supplementation in Oxidative Stress, Inflammation and Blood Pressure, sponsored by Fudan University. Completed at 1 site in China. Open to participants aged 18 Years to 27 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Fudan University · Not applicable, Interventional, and Prevention
This study aims to evaluate whether dietary supplementation with fish oil can protect against the cardiopulmonary alterations linked to air pollution
The investigators conduct a randomized controlled trial among 70 healthy college students in Shanghai, China. These students fulfilling the recruitment criteria will be randomly divided into two parallel groups to receive either fish oil [marine-derived n-3 polyunsaturated fatty acids (PUFA)] or sunflower seed oil. Participants in fish oil group receive 2.5 g/day (two 1.25-g capsules daily) in divided doses. The sunflower seed oil capsules are identical. All interventions started at 7:30 a.m.to avoid issues related to diurnal variation. Health endpoints, including blood pressure, skin color, fractional exhaled nitric oxide and pulmonary function were evaluated and biological samples such as morning urine, fast blood, saliva sample,buccal cells and skin tape stripping will be collected at week 1 before supplemenatation, and week 8, week 10, week 12 as well as week 14 during the supplementation phase.The investigators measure personal real-time exposure to PM2.5 and personal temperature and relative humidity.
Exclusion Criteria:
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Dietary Supplement: Fish oil supplementation
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Dietary Supplement: Sunflower seed oil supplementation
Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules.
Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD)
Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure 2 biomarkers of antioxidant activity, including TAC and SOD. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α)
2 inflammatory biomarkers in our study including IL-6 and TNF-α are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Cogulation Biomarker-von Willebrand Factor (vWF)
We measure vWF level in serum, one of the measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Biomarkers of Endothelial Function and Stress Hormone
We measure endothelial function biomarkers, including E-selectin and endothelial nitric oxide synthase (eNOS), and 4 stress hormones, including corticotropin releasing hormone (CRH), adrenocorticotropic hormone (ACTH), cortisol and serotonin. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Endothelial Function Biomarker-Endothelin-1(ET-1)
We measure ET-1 level in serum, an endothelial function biomarker. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Cogulation Biomarker-Fibrinogen
We measure the serum level of fibrinogen, one of the two measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker
The serum levels of hs-CRP are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker
Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of ox-LDL. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity
Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We also measure GSH-Px. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress
Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of LPO. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Blood Pressure
After sitting in a quiet room for at least 5 min, participants had their left upper arm blood pressure measured by trained technicians using an electronic sphygmomanometer at least three times with 3-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP (SBP) and diastolic BP (DBP). If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements was arranged. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Blood pressure are measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Insulin Resistance
The biomarker of insulin resistance is measured, calculated by fasting glucose and fasting insulin using the formula of \[fasting insulin (mU/L) × fasting glucose (mmol/L)\]/22.5. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Skin Inflammation Biomarkers
2 infammation biomarkers from skin samplings are measured, including interleukin-1 Alpha (IL-1α) and Interleukin-1 receptor antagonist (IL-1Rα). The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Skin Oxidative Stress Biomarker-Carbonyl Protein
oxidative stress biomarker in skin samplings includes carbonyl protein. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.
Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)
Indicators of lung function include forced vital capacity (FVC) and andforced expiratory volume in 1 second (FEV1). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Lung function is measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Lung Function-Peak Expiratory Flow (PEF)
Additional indicator of lung function includes peak expiratory flow (PEF). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Lung function is measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC)
we measure TAC level, an antioxidant biomarker in skin samplings. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.
Skin Antioxidant Biomarker-Glutataione (GSH)
we measure another skin antioxidant biomarker-GSH, . The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Time frame: Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.
Recruitment was conducted on Agust, 2017 in Fenglin Campus, Fudan University. A total of 93 participants were assessed for eligibility and 70 of them were finally recruited.
| Milestone | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Started | 35 | 35 |
| Completed | 34 | 32 |
| Not completed | 1 | 3 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Milestone | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Started | 34 | 32 |
| Completed | 34 | 31 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Started | 34 | 31 |
| Completed | 34 | 31 |
| Not completed | 0 | 0 |
| Milestone | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Started | 34 | 31 |
| Completed | 34 | 31 |
| Not completed | 0 | 0 |
| Milestone | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Started | 34 | 31 |
| Completed | 34 | 31 |
| Not completed | 0 | 0 |
Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure 2 biomarkers of antioxidant activity, including TAC and SOD. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| U/ml | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| TAC | 6.09 ± 2.15 | 5.80 ± 2.36 |
| SOD | 364.34 ± 42.69 | 356.59 ± 43.90 |
2 inflammatory biomarkers in our study including IL-6 and TNF-α are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| pg/ml | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| IL-6 | 0.72 ± 0.63 | 1.76 ± 5.75 |
| TNF-α | 0.35 ± 0.47 | 0.54 ± 1.42 |
We measure vWF level in serum, one of the measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| mIU/ml | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Cogulation Biomarker-von Willebrand Factor (vWF) | 1669.70 ± 1022.98 | 2144.30 ± 1674.32 |
We measure endothelial function biomarkers, including E-selectin and endothelial nitric oxide synthase (eNOS), and 4 stress hormones, including corticotropin releasing hormone (CRH), adrenocorticotropic hormone (ACTH), cortisol and serotonin. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| ng/ml | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| E-selectin | 12.23 ± 5.38 | 14.16 ± 6.81 |
| eNOS | 5.99 ± 9.19 | 4.29 ± 7.55 |
| CRH | 2.96 ± 0.48 | 3.06 ± 0.47 |
| Cortisol | 168.01 ± 48.62 | 184.49 ± 68.42 |
| ACTH | 0.34 ± 0.10 | 0.39 ± 0.12 |
| serotonin | 153.56 ± 63.89 | 151.17 ± 61.63 |
We measure ET-1 level in serum, an endothelial function biomarker. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| pg/ml | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Endothelial Function Biomarker-Endothelin-1(ET-1) | 1.80 ± 2.26 | 2.82 ± 4.92 |
We measure the serum level of fibrinogen, one of the two measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| µg/ml | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Cogulation Biomarker-Fibrinogen | 2.25 ± 1.06 | 2.63 ± 1.28 |
The serum levels of hs-CRP are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| µg/ml | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker | 12.81 ± 19.91 | 19.93 ± 30.03 |
Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of ox-LDL. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| U/L | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker | 34.74 ± 9.85 | 40.11 ± 22.83 |
Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We also measure GSH-Px. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| mU/ml | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity | 625.95 ± 157.42 | 581.51 ± 171.92 |
Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of LPO. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| µg/ml | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress | 0.54 ± 0.15 | 0.58 ± 0.17 |
After sitting in a quiet room for at least 5 min, participants had their left upper arm blood pressure measured by trained technicians using an electronic sphygmomanometer at least three times with 3-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP (SBP) and diastolic BP (DBP). If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements was arranged. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| mmHg | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| SBP | 110.01 ± 11.39 | 111.55 ± 10.89 |
| DBP | 67.20 ± 6.05 | 67.29 ± 7.97 |
The biomarker of insulin resistance is measured, calculated by fasting glucose and fasting insulin using the formula of \[fasting insulin (mU/L) × fasting glucose (mmol/L)\]/22.5. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| mmol/L × mU/L | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Insulin Resistance | 1.40 ± 0.94 | 1.42 ± 0.91 |
2 infammation biomarkers from skin samplings are measured, including interleukin-1 Alpha (IL-1α) and Interleukin-1 receptor antagonist (IL-1Rα). The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| pg/ml | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| IL-1α | 184.49 ± 107.31 | 230.90 ± 163.97 |
| IL-1Rα | 54.00 ± 93.48 | 42.00 ± 119.54 |
oxidative stress biomarker in skin samplings includes carbonyl protein. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| µg/ml | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Skin Oxidative Stress Biomarker-Carbonyl Protein | 35.93 ± 15.37 | 44.89 ± 24.01 |
Indicators of lung function include forced vital capacity (FVC) and andforced expiratory volume in 1 second (FEV1). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| L | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| FVC | 3.18 ± 0.48 | 3.16 ± 0.62 |
| FEV1 | 3.75 ± 0.64 | 3.73 ± 0.87 |
Additional indicator of lung function includes peak expiratory flow (PEF). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| L/s | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Lung Function-Peak Expiratory Flow (PEF) | 6.55 ± 1.44 | 6.38 ± 1.60 |
we measure TAC level, an antioxidant biomarker in skin samplings. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| nmol/mL | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC) | 42.99 ± 95.34 | 35.73 ± 17.55 |
we measure another skin antioxidant biomarker-GSH, . The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
| ppb | Fish Oil Supplementation | Sunflower Seed Oil Supplementation |
|---|---|---|
| Skin Antioxidant Biomarker-Glutataione (GSH) | 2.21 ± 1.70 | 0.42 ± 1.07 |
Mass spectrometry-based serum metabolomics is non-targeted. The study is to find the differential metabolites in serum between fish oil and placebo groups.
Results for this outcome have not been posted.
Collected over At the end of week 8, week 10, week 12 and week 14 during the period of supllementation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fish Oil Supplementation | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Sunflower Seed Oil Supplementation | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Continuous(years) | Fish Oil Supplementation | Sunflower Seed Oil Supplementation | Total |
|---|---|---|---|
| Mean | 23.03 ± 2.26 | 22.87 ± 1.28 | 22.95 ± 1.85 |
| Sex: Female, Male(Participants) | Fish Oil Supplementation | Sunflower Seed Oil Supplementation | Total |
|---|---|---|---|
| Female | 20 | 18 | 38 |
| Male | 14 | 13 | 27 |
| Race (NIH/OMB)(Participants) | Fish Oil Supplementation | Sunflower Seed Oil Supplementation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 34 | 31 | 65 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Fish Oil Supplementation | Sunflower Seed Oil Supplementation | Total |
|---|---|---|---|
| China | 34 | 31 | 65 |
| Body mass index(kg/m^2) | Fish Oil Supplementation | Sunflower Seed Oil Supplementation | Total |
|---|---|---|---|
| Mean | 21.73 ± 3.23 | 21.56 ± 3.02 | 21.65 ± 3.10 |
| Physical activity(Participants) | Fish Oil Supplementation | Sunflower Seed Oil Supplementation | Total |
|---|---|---|---|
| Never | 31 | 27 | 58 |
| Mild | 2 | 3 | 5 |
| Moderate | 1 | 1 | 2 |
| Vigorous | 0 | 0 | 0 |
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Fudan University