Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution

NCT03255187 | Completed Results DMC

• 1 other identifier: FDUEH-3
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate whether dietary supplementation with fish oil can protect against the cardiopulmonary alterations linked to air pollution

Conditions

Oxidative Stress; Inflammation; Blood Pressure; Vasoconstriction; Coagulation; Pulmonary Function

Keywords

Biomarker; Fish oil; Oxidative stress; Air pollution; Cardiopulmonary system

Outcome Measures

Primary Outcomes (10)

• Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD)

  Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure 2 biomarkers of antioxidant activity, including TAC and SOD. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.

• Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α)

  2 inflammatory biomarkers in our study including IL-6 and TNF-α are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.

• Cogulation Biomarker-von Willebrand Factor (vWF)

  We measure vWF level in serum, one of the measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.

• Biomarkers of Endothelial Function and Stress Hormone

  We measure endothelial function biomarkers, including E-selectin and endothelial nitric oxide synthase (eNOS), and 4 stress hormones, including corticotropin releasing hormone (CRH), adrenocorticotropic hormone (ACTH), cortisol and serotonin. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.

• Endothelial Function Biomarker-Endothelin-1(ET-1)

  We measure ET-1 level in serum, an endothelial function biomarker. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.

• Cogulation Biomarker-Fibrinogen

  We measure the serum level of fibrinogen, one of the two measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.

• High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker

  The serum levels of hs-CRP are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.

• Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker

  Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of ox-LDL. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.

• Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity

  Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We also measure GSH-Px. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.

• Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress

  Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of LPO. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.

Secondary Outcomes (8)

• Blood Pressure

  Blood pressure are measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.

• Insulin Resistance

  Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.

• Skin Inflammation Biomarkers

  Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.

• Skin Oxidative Stress Biomarker-Carbonyl Protein

  Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.

• Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)

  Lung function is measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.

Study Arms (2)

Fish oil supplementation

EXPERIMENTAL

This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.

Dietary Supplement: Fish oil supplementation

Sunflower seed oil supplementation

PLACEBO COMPARATOR

This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.

Dietary Supplement: Sunflower seed oil supplementation

Interventions

Fish oil supplementation DIETARY_SUPPLEMENT

Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].

Fish oil supplementation

Sunflower seed oil supplementation DIETARY_SUPPLEMENT

Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules.

Sunflower seed oil supplementation

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Equal to or older than 18 years old.
• No history of smoking and alcohol addiction.
• No chronic diseases or respiratory or allergic diseases,such as hypertension,diabetes,chronic obstructive pulmonary disease,other respiratory/cardiovascular diseases, asthma, rhinitis or other allergic diseases reported by volunteers.
• No allergies to n-3 PUFA or fish.

You may not qualify if:

• Current smokers or ever smokers
• Chronic drug use due on cardiovascular or respiratory diseases
• Participants are taking fish oil,anti-inflammatory drugs, or antioxidant supplements (such as vitamin C or vitamin E)

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (2)

• Zhou L, Jiang Y, Lin Z, Chen R, Niu Y, Kan H. Mechanistic insights into the health benefits of fish-oil supplementation against fine particulate matter air pollution: a randomized controlled trial. Environ Health. 2022 Oct 29;21(1):104. doi: 10.1186/s12940-022-00908-1.

  PMID: 36309727 DERIVED

• Lin Z, Chen R, Jiang Y, Xia Y, Niu Y, Wang C, Liu C, Chen C, Ge Y, Wang W, Yin G, Cai J, Clement V, Xu X, Chen B, Chen H, Kan H. Cardiovascular Benefits of Fish-Oil Supplementation Against Fine Particulate Air Pollution in China. J Am Coll Cardiol. 2019 Apr 30;73(16):2076-2085. doi: 10.1016/j.jacc.2018.12.093.

  PMID: 31023432 DERIVED

MeSH Terms

Conditions

Inflammation; Thrombosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Haidong Kan
• Organization: Department of Environmental Health, School of Public Health, Fudan University

kanh@fudan.edu.cn

86-21-54237908

Study Officials

• Haidong Kan

  School of Public Health，Fudan University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Participants are randomly assigned to two parallel groups at enrollment using a random-number table. And the investigators randomly assign the two groups in a double-blind fashion receive either fish oil or sunflower seed oil for 4 months.

Study Record Dates

• First Submitted: August 12, 2017
• First Posted: August 21, 2017
• Study Start: September 9, 2017
• Primary Completion: January 13, 2018
• Study Completion: January 13, 2018
• Last Updated: April 23, 2024
• Results First Posted: January 21, 2020

Record last verified: 2024-04

Locations

CN (1)