Clinical trial NCT03697499: Effects of Fish Oil in Alleviating Health Hazards Associated With Ozone Exposure
Official title: Effects of Fish Oil in Alleviating Cardiopulmonary Hazards Associated With Ozone Exposure in Young Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular System
Respiratory System
Oxidative Stress
Inflammation
Keywords: ozone exposure
fish oil
2*2 factorial design
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate whether dietary supplementation with fish oil can protect against the cardiopulmonary effects induced by ozone exposure.

Detailed description: The investigators will conduct a randomized controlled trial among 64 healthy young adults in Shanghai, China. The eligible participants will be randomly assigned in a 2\*2 factorial design to 1 of 4 groups: 1) fish oil and ozone exposure, 2) fish oil and shame exposure, 3) soy oil and ozone exposure, or 4) soy oil and shame exposure. The participants who take fish oil would receive 2.2 g/day (two 1.1-g capsules daily) in divided doses, and other participants will take the same amount of soy oil capsules. Two hour ozone exposure (200 ppb ozone) or shame exposure (0 ppb ozone) will be conducted in a chamber after four weeks of supplementation. Ozone is generated by a silent electric discharge method (HTU-500, AZCO Industries Ltd., Canada) and introduced into the chamber. The temperature and relative humidity in the chamber are maintained at 22±1℃ and 50%±5%, respectively. During the 2-hour exposure, each subject alternate 15 minutes of exercise on a treadmill and 15 minutes of rest. The exercise workload would be adjusted to achieve the targeted ventilation of 20±1 L/min/m2 body surface area. Health examinations will be conducted immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning.

Eligibility criteria: Inclusion Criteria:

* Living in Shanghai during study period;
* Ability to complete the training exercise to induce an inspired ventilation rate of 20±1 L/min/m2 body surface area;
* Body mass index \>18.5 and ≤30 (30 is the lower limit for class 2 obesity for Chinese);
* Taking the fish oil or placebo on time.

Exclusion Criteria:

* Being allergic to seafood;
* Smoking and alcohol abuse;
* Current drug and dietary supplements intake;
* Subjects with allergic disease, such as allergic rhinitis, allergic asthma, and atopy;
* Subjects with cardiovascular disease, such as congenital heart disease, pulmonary heart disease, and hypertension;
* Subjects with respiratory disease, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
* Subjects with chronic disease, such as diabetes, chronic hepatitis, and kidney disease;
* Subjects with a history of major surgery;
* Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
* Abnormal baseline 12-lead resting electrocardiogram;
* Abnormal blood index, such as cell counting, blood lipids, and glutamic-pyruvic transaminase (GPT).

Primary outcomes:
measure: Changes of FEV1
timeFrame: FEV1 will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning
measure: Changes of FVC
timeFrame: FVC will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Environmental Health, School of Public Health, Fudan University
state: Shanghai
Study officials:
affiliation: Department of Environmental Health, School of Public Health, Fudan University
name: Haidong Kan, PhD
role: PRINCIPAL_INVESTIGATOR
References: