Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
Primary Purpose
Oxidative Stress, Inflammation, Blood Pressure
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fish oil supplementation
Sunflower seed oil supplementation
Sponsored by
About this trial
This is an interventional prevention trial for Oxidative Stress focused on measuring Biomarker, Fish oil, Oxidative stress, Air pollution, Cardiopulmonary system
Eligibility Criteria
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)
Sites / Locations
- Department of Environmental Health, School of Public Health, Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fish oil supplementation
Sunflower seed oil supplementation
Arm Description
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.
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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 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.
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-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.
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 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03255187
Brief Title
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
Official Title
Effect of Dietary Supplementation With Fish Oil in Alleviating Cardiopulmonary Hazards Associated With Air Pollution
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 9, 2017 (Actual)
Primary Completion Date
January 13, 2018 (Actual)
Study Completion Date
January 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Inflammation, Blood Pressure, Vasoconstriction, Coagulation, Pulmonary Function
Keywords
Biomarker, Fish oil, Oxidative stress, Air pollution, Cardiopulmonary system
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fish oil supplementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sunflower seed oil supplementation
Arm Type
Placebo Comparator
Arm Description
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil supplementation
Intervention Description
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)].
Intervention Type
Dietary Supplement
Intervention Name(s)
Sunflower seed oil supplementation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD)
Description
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.
Title
Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α)
Description
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.
Title
Cogulation Biomarker-von Willebrand Factor (vWF)
Description
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.
Title
Biomarkers of Endothelial Function and Stress Hormone
Description
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.
Title
Endothelial Function Biomarker-Endothelin-1(ET-1)
Description
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.
Title
Cogulation Biomarker-Fibrinogen
Description
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.
Title
High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker
Description
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.
Title
Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker
Description
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.
Title
Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity
Description
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.
Title
Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress
Description
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.
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
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.
Title
Insulin Resistance
Description
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.
Title
Skin Inflammation Biomarkers
Description
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.
Title
Skin Oxidative Stress Biomarker-Carbonyl Protein
Description
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.
Title
Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)
Description
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.
Title
Lung Function-Peak Expiratory Flow (PEF)
Description
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.
Title
Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC)
Description
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.
Title
Skin Antioxidant Biomarker-Glutataione (GSH)
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haidong Kan
Organizational Affiliation
School of Public Health,Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Environmental Health, School of Public Health, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
36309727
Citation
Zhou L, Jiang Y, Lin Z, Chen R, Niu Y, Kan H. Mechanistic insights into the health benefits of fish-oil supplementation against fine particulate matter air pollution: a randomized controlled trial. Environ Health. 2022 Oct 29;21(1):104. doi: 10.1186/s12940-022-00908-1.
Results Reference
derived
PubMed Identifier
31023432
Citation
Lin Z, Chen R, Jiang Y, Xia Y, Niu Y, Wang C, Liu C, Chen C, Ge Y, Wang W, Yin G, Cai J, Clement V, Xu X, Chen B, Chen H, Kan H. Cardiovascular Benefits of Fish-Oil Supplementation Against Fine Particulate Air Pollution in China. J Am Coll Cardiol. 2019 Apr 30;73(16):2076-2085. doi: 10.1016/j.jacc.2018.12.093.
Results Reference
derived
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Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
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