Clinical trial NCT03255187: 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
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Inflammation
Blood Pressure
Vasoconstriction
Coagulation
Pulmonary Function
Keywords: Biomarker
Fish oil
Oxidative stress
Air pollution
Cardiopulmonary system
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD)
timeFrame: 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.
measure: Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α)
timeFrame: 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.
measure: Cogulation Biomarker-von Willebrand Factor (vWF)
timeFrame: 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.
measure: Biomarkers of Endothelial Function and Stress Hormone
timeFrame: 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.
measure: Endothelial Function Biomarker-Endothelin-1(ET-1)
timeFrame: 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.
measure: Cogulation Biomarker-Fibrinogen
timeFrame: 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.
measure: High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker
timeFrame: 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.
measure: Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker
timeFrame: 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.
measure: Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity
timeFrame: 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.
measure: Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress
timeFrame: 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 outcomes:
measure: Blood Pressure
timeFrame: 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.
measure: Insulin Resistance
timeFrame: 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.
measure: Skin Inflammation Biomarkers
timeFrame: 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.
measure: Skin Oxidative Stress Biomarker-Carbonyl Protein
timeFrame: 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.
measure: Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: 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.
measure: Lung Function-Peak Expiratory Flow (PEF)
timeFrame: 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.
measure: Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC)
timeFrame: 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.
measure: Skin Antioxidant Biomarker-Glutataione (GSH)
timeFrame: 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.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Environmental Health, School of Public Health, Fudan University
state: Shanghai
Study officials:
affiliation: School of Public Health，Fudan University
name: Haidong Kan
role: STUDY_DIRECTOR
References:
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.
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.