Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution

Study Overview
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Brief Summary
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This study aims to evaluate whether dietary supplementation with fish oil can protect against the cardiopulmonary alterations linked to air pollution

Detailed Description
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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, 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.

Official Title
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Effect of Dietary Supplementation With Fish Oil in Alleviating Cardiopulmonary Hazards Associated With Air Pollution

Conditions
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Oxidative Stress, Inflammation, Blood Pressure, Vasoconstriction, Coagulation, Pulmonary Function

Intervention / Treatment
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* Dietary Supplement: Fish oil supplementation
* Dietary Supplement: Sunflower seed oil supplementation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 27 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil supplementation<br>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<br>* 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)].<br>|
| Placebo Comparator: Sunflower seed oil supplementation<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarker, Fish oil, Oxidative stress, Air pollution, Cardiopulmonary system