Effects of Fish Oil in Alleviating Health Hazards Associated With Ozone Exposure

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

Detailed Description
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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.

Official Title
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Effects of Fish Oil in Alleviating Cardiopulmonary Hazards Associated With Ozone Exposure in Young Healthy Adults

Conditions
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Inflammation, Cardiovascular System, Respiratory System, Oxidative Stress

Intervention / Treatment
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* Combination Product: fish oil and acute ozone exposure
* Combination Product: fish oil and sham exposure
* Combination Product: soy oil and acute ozone exposure
* Combination Product: soy oil and sham exposure


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fish oil and acute ozone exposure<br>The participants will take fish oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour ozone exposure (200 ppb ozone) will be conducted in a chamber after four weeks of supplementation. | Combination Product: fish oil and acute ozone exposure<br>* The participants will take fish oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour ozone exposure (200 ppb ozone) will be conducted in a chamber after four weeks of supplementation.<br>|
| Sham Comparator: fish oil and shame exposure<br>The participants will take fish oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour shame exposure (0 ppb ozone) will be conducted in a chamber after four weeks of supplementation. | Combination Product: fish oil and sham exposure<br>* The participants will take fish oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour shame exposure (0 ppb ozone) will be conducted in a chamber after four weeks of supplementation.<br>|
| Placebo Comparator: soy oil and acute ozone exposure<br>The participants will take soy oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour ozone exposure (200 ppb ozone) will be conducted in a chamber after four weeks of supplementation. | Combination Product: soy oil and acute ozone exposure<br>* The participants will take soy oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour ozone exposure (200 ppb ozone) will be conducted in a chamber after four weeks of supplementation.<br>|
| Other: soy oil and shame exposure<br>The participants will take soy oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour shame exposure (0 ppb ozone) will be conducted in a chamber after four weeks of supplementation. | Combination Product: soy oil and sham exposure<br>* The participants will take soy oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour shame exposure (0 ppb ozone) will be conducted in a chamber after four weeks of supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of FEV1 | Changes of forced expiratory volume in 1 second | FEV1 will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning | 
| Changes of FVC | Changes of forced vital capacity | FVC will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ozone exposure, fish oil, 2*2 factorial design