- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03255187
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
July 9, 2022 updated by: Haidong Kan, Fudan University
Effect of Dietary Supplementation With Fish Oil in Alleviating Cardiopulmonary Hazards Associated With Air Pollution
This study aims to evaluate whether dietary supplementation with fish oil can protect against the cardiopulmonary alterations linked to air pollution
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200032
- Department of Environmental Health, School of Public Health, Fudan University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 27 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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)].
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Placebo Comparator: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD)
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.
|
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.
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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.
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Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α)
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.
|
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.
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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.
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Cogulation Biomarker-von Willebrand Factor (vWF)
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.
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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.
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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.
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Biomarkers of Endothelial Function and Stress Hormone
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.
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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.
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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.
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Endothelial Function Biomarker-Endothelin-1(ET-1)
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.
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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.
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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.
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Cogulation Biomarker-Fibrinogen
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.
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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.
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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.
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High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker
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.
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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.
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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.
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Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker
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.
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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.
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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.
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Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity
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.
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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.
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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.
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Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress
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.
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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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure
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.
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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.
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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.
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Insulin Resistance
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.
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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.
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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.
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Skin Inflammation Biomarkers
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.
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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.
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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.
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Skin Oxidative Stress Biomarker-Carbonyl Protein
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.
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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.
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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.
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Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)
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.
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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.
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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.
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Lung Function-Peak Expiratory Flow (PEF)
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.
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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.
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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.
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Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC)
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.
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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.
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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.
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Skin Antioxidant Biomarker-Glutataione (GSH)
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.
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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.
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Haidong Kan, School of Public Health,Fudan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2017
Primary Completion (Actual)
January 13, 2018
Study Completion (Actual)
January 13, 2018
Study Registration Dates
First Submitted
August 12, 2017
First Submitted That Met QC Criteria
August 16, 2017
First Posted (Actual)
August 21, 2017
Study Record Updates
Last Update Posted (Actual)
August 2, 2022
Last Update Submitted That Met QC Criteria
July 9, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDUEH-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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