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

Fudan University

Status: Completed

Conditions: Inflammation; Cardiovascular System; Oxidative Stress; Respiratory System

Treatments: Combination Product: fish oil and sham exposure; Combination Product: soy oil and acute ozone exposure; Combination Product: fish oil and acute ozone exposure; Combination Product: soy oil and sham exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT03697499

FDUEH-4

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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64 participants in 4 patient groups, including a placebo group

fish oil and acute ozone exposure

Experimental group

Description:

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.

Treatment:

Combination Product: fish oil and acute ozone exposure

fish oil and shame exposure

Sham Comparator group

Description:

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.

Treatment:

Combination Product: fish oil and sham exposure

soy oil and acute ozone exposure

Placebo Comparator group

Description:

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.

Treatment:

Combination Product: soy oil and acute ozone exposure

soy oil and shame exposure

Other group

Description:

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.

Treatment:

Combination Product: soy oil and sham exposure