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

NCT ID: NCT03697499

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-20
• Study Completion Date: 2019-12-30

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.

Conditions

Cardiovascular System; Respiratory System; Oxidative Stress; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

fish oil and acute ozone exposure

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.

Group Type: EXPERIMENTAL

fish oil and acute ozone exposure

Intervention Type: COMBINATION_PRODUCT

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.

fish oil and shame exposure

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.

Group Type: SHAM_COMPARATOR

fish oil and sham exposure

Intervention Type: COMBINATION_PRODUCT

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.

soy oil and acute ozone exposure

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.

Group Type: PLACEBO_COMPARATOR

soy oil and acute ozone exposure

Intervention Type: COMBINATION_PRODUCT

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.

soy oil and shame exposure

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.

Group Type: OTHER

soy oil and sham exposure

Intervention Type: COMBINATION_PRODUCT

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

Interventions

fish oil and acute ozone exposure

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.

Intervention Type: COMBINATION_PRODUCT

fish oil and sham exposure

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.

Intervention Type: COMBINATION_PRODUCT

soy oil and acute ozone exposure

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.

Intervention Type: COMBINATION_PRODUCT

soy oil and sham exposure

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

Intervention Type: COMBINATION_PRODUCT

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Haidong Kan

PhD and Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haidong Kan, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Environmental Health, School of Public Health, Fudan University

Locations

Department of Environmental Health, School of Public Health, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

FDUEH-4

Identifier Type: -

Identifier Source: org_study_id