Blood Pressure, Coagulation, Inflammation, Oxidative Stress, Pulmonary Function, Vasoconstriction
Conditions
Keywords
Biomarker, Fish oil, Oxidative stress, Air pollution, Cardiopulmonary system
Brief summary
This study aims to evaluate whether dietary supplementation with fish oil can protect against the cardiopulmonary alterations linked to air pollution
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTFish 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 \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
DIETARY_SUPPLEMENTSunflower 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 sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants are randomly assigned to two parallel groups at enrollment using a random-number table. And the investigators randomly assign the two groups in a double-blind fashion receive either fish oil or sunflower seed oil for 4 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 27 Years
Healthy volunteers
Yes
Inclusion criteria
* Equal to or older than 18 years old. * No history of smoking and alcohol addiction. * No chronic diseases or respiratory or allergic diseases,such as hypertension,diabetes,chronic obstructive pulmonary disease,other respiratory/cardiovascular diseases, asthma, rhinitis or other allergic diseases reported by volunteers. * No allergies to n-3 PUFA or fish.
Exclusion criteria
* Current smokers or ever smokers * Chronic drug use due on cardiovascular or respiratory diseases * Participants are taking fish oil,anti-inflammatory drugs, or antioxidant supplements (such as vitamin C or vitamin E)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress | 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. | 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. |
| Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α) | 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. | 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. |
| Cogulation Biomarker-von Willebrand Factor (vWF) | 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. | 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. |
| Biomarkers of Endothelial Function and Stress Hormone | 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. | 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. |
| Endothelial Function Biomarker-Endothelin-1(ET-1) | 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. | 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. |
| Cogulation Biomarker-Fibrinogen | 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. | 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. |
| High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker | 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. | 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. |
| Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker | 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. | 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. |
| Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity | 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. | 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. |
| Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD) | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Resistance | 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. | 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. |
| Skin Inflammation Biomarkers | 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. | 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. |
| Skin Oxidative Stress Biomarker-Carbonyl Protein | 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. | 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. |
| Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) | 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. | 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. |
| Lung Function-Peak Expiratory Flow (PEF) | 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. | 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. |
| Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC) | 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. | 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. |
| Skin Antioxidant Biomarker-Glutataione (GSH) | 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. | 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. |
| Blood Pressure | 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. | 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. |
Countries
China
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Fish Oil Supplementation 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.
Fish 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 \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\]. | 34 |
| Sunflower Seed Oil Supplementation This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
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 sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6). | 31 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Periodfrom Enrollment to First Follow-up | Withdrawal by Subject | 1 | 3 |
| Period From First to Second Follow-up | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Fish Oil Supplementation | Total | Sunflower Seed Oil Supplementation |
|---|---|---|---|
| Age, Continuous | 23.03 years STANDARD_DEVIATION 2.26 | 22.95 years STANDARD_DEVIATION 1.85 | 22.87 years STANDARD_DEVIATION 1.28 |
| Body mass index | 21.73 kg/m^2 STANDARD_DEVIATION 3.23 | 21.65 kg/m^2 STANDARD_DEVIATION 3.1 | 21.56 kg/m^2 STANDARD_DEVIATION 3.02 |
| Physical activity Mild | 2 Participants | 5 Participants | 3 Participants |
| Physical activity Moderate | 1 Participants | 2 Participants | 1 Participants |
| Physical activity Never | 31 Participants | 58 Participants | 27 Participants |
| Physical activity Vigorous | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 34 Participants | 65 Participants | 31 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 34 participants | 65 participants | 31 participants |
| Sex: Female, Male Female | 20 Participants | 38 Participants | 18 Participants |
| Sex: Female, Male Male | 14 Participants | 27 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 31 |
| other Total, other adverse events | 0 / 34 | 0 / 31 |
| serious Total, serious adverse events | 0 / 34 | 0 / 31 |
Outcome results
Primary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fish Oil Supplementation | Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD) | TAC | 6.09 U/ml | Standard Deviation 2.15 |
| Fish Oil Supplementation | Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD) | SOD | 364.34 U/ml | Standard Deviation 42.69 |
| Sunflower Seed Oil Supplementation | Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD) | TAC | 5.80 U/ml | Standard Deviation 2.36 |
| Sunflower Seed Oil Supplementation | Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD) | SOD | 356.59 U/ml | Standard Deviation 43.9 |
Primary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fish Oil Supplementation | Biomarkers of Endothelial Function and Stress Hormone | E-selectin | 12.23 ng/ml | Standard Deviation 5.38 |
| Fish Oil Supplementation | Biomarkers of Endothelial Function and Stress Hormone | eNOS | 5.99 ng/ml | Standard Deviation 9.19 |
| Fish Oil Supplementation | Biomarkers of Endothelial Function and Stress Hormone | CRH | 2.96 ng/ml | Standard Deviation 0.48 |
| Fish Oil Supplementation | Biomarkers of Endothelial Function and Stress Hormone | Cortisol | 168.01 ng/ml | Standard Deviation 48.62 |
| Fish Oil Supplementation | Biomarkers of Endothelial Function and Stress Hormone | ACTH | 0.34 ng/ml | Standard Deviation 0.1 |
| Fish Oil Supplementation | Biomarkers of Endothelial Function and Stress Hormone | serotonin | 153.56 ng/ml | Standard Deviation 63.89 |
| Sunflower Seed Oil Supplementation | Biomarkers of Endothelial Function and Stress Hormone | ACTH | 0.39 ng/ml | Standard Deviation 0.12 |
| Sunflower Seed Oil Supplementation | Biomarkers of Endothelial Function and Stress Hormone | E-selectin | 14.16 ng/ml | Standard Deviation 6.81 |
| Sunflower Seed Oil Supplementation | Biomarkers of Endothelial Function and Stress Hormone | Cortisol | 184.49 ng/ml | Standard Deviation 68.42 |
| Sunflower Seed Oil Supplementation | Biomarkers of Endothelial Function and Stress Hormone | eNOS | 4.29 ng/ml | Standard Deviation 7.55 |
| Sunflower Seed Oil Supplementation | Biomarkers of Endothelial Function and Stress Hormone | serotonin | 151.17 ng/ml | Standard Deviation 61.63 |
| Sunflower Seed Oil Supplementation | Biomarkers of Endothelial Function and Stress Hormone | CRH | 3.06 ng/ml | Standard Deviation 0.47 |
Primary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fish Oil Supplementation | Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α) | IL-6 | 0.72 pg/ml | Standard Deviation 0.63 |
| Fish Oil Supplementation | Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α) | TNF-α | 0.35 pg/ml | Standard Deviation 0.47 |
| Sunflower Seed Oil Supplementation | Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α) | IL-6 | 1.76 pg/ml | Standard Deviation 5.75 |
| Sunflower Seed Oil Supplementation | Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α) | TNF-α | 0.54 pg/ml | Standard Deviation 1.42 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil Supplementation | Cogulation Biomarker-Fibrinogen | 2.25 µg/ml | Standard Deviation 1.06 |
| Sunflower Seed Oil Supplementation | Cogulation Biomarker-Fibrinogen | 2.63 µg/ml | Standard Deviation 1.28 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil Supplementation | Cogulation Biomarker-von Willebrand Factor (vWF) | 1669.70 mIU/ml | Standard Deviation 1022.98 |
| Sunflower Seed Oil Supplementation | Cogulation Biomarker-von Willebrand Factor (vWF) | 2144.30 mIU/ml | Standard Deviation 1674.32 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil Supplementation | Endothelial Function Biomarker-Endothelin-1(ET-1) | 1.80 pg/ml | Standard Deviation 2.26 |
| Sunflower Seed Oil Supplementation | Endothelial Function Biomarker-Endothelin-1(ET-1) | 2.82 pg/ml | Standard Deviation 4.92 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil Supplementation | Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity | 625.95 mU/ml | Standard Deviation 157.42 |
| Sunflower Seed Oil Supplementation | Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity | 581.51 mU/ml | Standard Deviation 171.92 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil Supplementation | High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker | 12.81 µg/ml | Standard Deviation 19.91 |
| Sunflower Seed Oil Supplementation | High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker | 19.93 µg/ml | Standard Deviation 30.03 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil Supplementation | Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker | 34.74 U/L | Standard Deviation 9.85 |
| Sunflower Seed Oil Supplementation | Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker | 40.11 U/L | Standard Deviation 22.83 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil Supplementation | Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress | 0.54 µg/ml | Standard Deviation 0.15 |
| Sunflower Seed Oil Supplementation | Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress | 0.58 µg/ml | Standard Deviation 0.17 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fish Oil Supplementation | Blood Pressure | SBP | 110.01 mmHg | Standard Deviation 11.39 |
| Fish Oil Supplementation | Blood Pressure | DBP | 67.20 mmHg | Standard Deviation 6.05 |
| Sunflower Seed Oil Supplementation | Blood Pressure | SBP | 111.55 mmHg | Standard Deviation 10.89 |
| Sunflower Seed Oil Supplementation | Blood Pressure | DBP | 67.29 mmHg | Standard Deviation 7.97 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil Supplementation | Insulin Resistance | 1.40 mmol/L × mU/L | Standard Deviation 0.94 |
| Sunflower Seed Oil Supplementation | Insulin Resistance | 1.42 mmol/L × mU/L | Standard Deviation 0.91 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fish Oil Supplementation | Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) | FVC | 3.18 L | Standard Deviation 0.48 |
| Fish Oil Supplementation | Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) | FEV1 | 3.75 L | Standard Deviation 0.64 |
| Sunflower Seed Oil Supplementation | Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) | FVC | 3.16 L | Standard Deviation 0.62 |
| Sunflower Seed Oil Supplementation | Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) | FEV1 | 3.73 L | Standard Deviation 0.87 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil Supplementation | Lung Function-Peak Expiratory Flow (PEF) | 6.55 L/s | Standard Deviation 1.44 |
| Sunflower Seed Oil Supplementation | Lung Function-Peak Expiratory Flow (PEF) | 6.38 L/s | Standard Deviation 1.6 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil Supplementation | Skin Antioxidant Biomarker-Glutataione (GSH) | 2.21 ppb | Standard Deviation 1.7 |
| Sunflower Seed Oil Supplementation | Skin Antioxidant Biomarker-Glutataione (GSH) | 0.42 ppb | Standard Deviation 1.07 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil Supplementation | Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC) | 42.99 nmol/mL | Standard Deviation 95.34 |
| Sunflower Seed Oil Supplementation | Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC) | 35.73 nmol/mL | Standard Deviation 17.55 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fish Oil Supplementation | Skin Inflammation Biomarkers | IL-1α | 184.49 pg/ml | Standard Deviation 107.31 |
| Fish Oil Supplementation | Skin Inflammation Biomarkers | IL-1Rα | 54.00 pg/ml | Standard Deviation 93.48 |
| Sunflower Seed Oil Supplementation | Skin Inflammation Biomarkers | IL-1α | 230.90 pg/ml | Standard Deviation 163.97 |
| Sunflower Seed Oil Supplementation | Skin Inflammation Biomarkers | IL-1Rα | 42.00 pg/ml | Standard Deviation 119.54 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil Supplementation | Skin Oxidative Stress Biomarker-Carbonyl Protein | 35.93 µg/ml | Standard Deviation 15.37 |
| Sunflower Seed Oil Supplementation | Skin Oxidative Stress Biomarker-Carbonyl Protein | 44.89 µg/ml | Standard Deviation 24.01 |
Post Hoc
Differences in Metabolite Levels Detected in Serum Metabolomics Between the Two Groups
Mass spectrometry-based serum metabolomics is non-targeted. The study is to find the differential metabolites in serum between fish oil and placebo groups.
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.