Trials / Completed
CompletedNCT03697499
Effects of Fish Oil in Alleviating Health Hazards Associated With Ozone Exposure
Effects of Fish Oil in Alleviating Cardiopulmonary Hazards Associated With Ozone Exposure in Young Healthy Adults
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Fudan University · Academic / Other
- Sex
- All
- Age
- 18 Years – 30 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | 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. |
| 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. |
| 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. |
| 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 |
Timeline
- Start date
- 2018-09-20
- Primary completion
- 2018-12-10
- Completion
- 2019-12-30
- First posted
- 2018-10-05
- Last updated
- 2020-02-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03697499. Inclusion in this directory is not an endorsement.