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

Not Applicable

Completed

• Conditions: Oxidative Stress; Pulmonary Function; Inflammation; Blood Pressure; Vasoconstriction; Coagulation
• Interventions: Dietary Supplement: Sunflower seed oil supplementation; Dietary Supplement: Fish oil supplementation

• Registration Number: NCT03255187
• Lead Sponsor: Fudan University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-12
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-21
• Study Start: 2017-09-09
• Primary Completion: 2018-01-13
• Study Completion: 2018-01-13
• Results First Submitted: 2019-10-13
• Results First Submitted QC: 2019-12-29
• Results First Posted: 2020-01-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sunflower seed oil supplementation	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.
Fish oil supplementation	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Department of Environmental Health, School of Public Health, Fudan University; 🇨🇳 Shanghai, Shanghai, China