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

Primary Purpose

Cardiovascular System, Respiratory System, Oxidative Stress

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
fish oil and acute ozone exposure
fish oil and sham exposure
soy oil and acute ozone exposure
soy oil and sham exposure
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular System focused on measuring ozone exposure, fish oil, 2*2 factorial design

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts 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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Placebo Comparator

Other

Arm Label

fish oil and acute ozone exposure

fish oil and shame exposure

soy oil and acute ozone exposure

soy oil and shame exposure

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Changes of FEV1
Changes of forced expiratory volume in 1 second
Changes of FVC
Changes of forced vital capacity

Secondary Outcome Measures

Full Information

First Posted
September 30, 2018
Last Updated
February 4, 2020
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT03697499
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular System, Respiratory System, Oxidative Stress, Inflammation
Keywords
ozone exposure, fish oil, 2*2 factorial design

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fish oil and acute ozone exposure
Arm Type
Experimental
Arm 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.
Arm Title
fish oil and shame exposure
Arm Type
Sham Comparator
Arm 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.
Arm Title
soy oil and acute ozone exposure
Arm Type
Placebo Comparator
Arm 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.
Arm Title
soy oil and shame exposure
Arm Type
Other
Arm 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.
Intervention Type
Combination Product
Intervention Name(s)
fish oil and acute ozone exposure
Intervention 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.
Intervention Type
Combination Product
Intervention Name(s)
fish oil and sham exposure
Intervention 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.
Intervention Type
Combination Product
Intervention Name(s)
soy oil and acute ozone exposure
Intervention 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.
Intervention Type
Combination Product
Intervention Name(s)
soy oil and sham exposure
Intervention 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
Primary Outcome Measure Information:
Title
Changes of FEV1
Description
Changes of forced expiratory volume in 1 second
Time Frame
FEV1 will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning
Title
Changes of FVC
Description
Changes of forced vital capacity
Time Frame
FVC will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haidong Kan, PhD
Organizational Affiliation
Department of Environmental Health, School of Public Health, Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Environmental Health, School of Public Health, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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