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

NCT03697499 | Completed

• 1 other identifier: FDUEH-4
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular System; Respiratory System; Oxidative Stress; Inflammation

Keywords

ozone exposure; fish oil; 2*2 factorial design

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

fish oil and acute ozone exposure

EXPERIMENTAL

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

fish oil and shame exposure

SHAM COMPARATOR

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

soy oil and acute ozone exposure

PLACEBO COMPARATOR

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

soy oil and shame exposure

OTHER

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

Interventions

fish oil and acute ozone exposure 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 acute ozone exposure

fish oil and sham exposure 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.

fish oil and shame exposure

soy oil and acute ozone exposure 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 acute ozone exposure

soy oil and sham exposure 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

soy oil and shame exposure

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Inflammation

Interventions

Fish Oils; Soybean Oil

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Haidong Kan, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD and Professor

Study Record Dates

• First Submitted: September 30, 2018
• First Posted: October 5, 2018
• Study Start: September 20, 2018
• Primary Completion: December 10, 2018
• Study Completion: December 30, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

CN (1)