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

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ClinicalTrials.gov Identifier: NCT03255187
Recruitment Status : Completed
First Posted : August 21, 2017
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Haidong Kan, Fudan University

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

Condition or disease Intervention/treatment Phase
Oxidative Stress Inflammation Blood Pressure Vasoconstriction Coagulation Pulmonary Function Dietary Supplement: Fish oil supplementation Dietary Supplement: Sunflower seed oil supplementation Not Applicable

Detailed Description:
The investigators conduct a randomized controlled trial among 70 healthy college students in Shanghai, China. These students fulfilling the recruitment criteria will be randomly divided into two parallel groups to receive either fish oil [marine-derived n-3 polyunsaturated fatty acids (PUFA)] or sunflower seed oil. Participants in fish oil group receive 2.5 g/day (two 1.25-g capsules daily) in divided doses. The sunflower seed oil capsules are identical. All interventions started at 7:30 a.m.to avoid issues related to diurnal variation. Health endpoints, including blood pressure, fractional exhaled nitric oxide and pulmonary function were evaluated and biological samples such as morning urine, fast blood, saliva sample,buccal cells and skin tape stripping will be collected at week 1 before supplemenatation, and week 8, week 10, week 12 as well as week 14 during the supplementation phase.The investigators measure personal real-time exposure to PM2.5 and personal temperature and relative humidity.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Dietary Supplementation With Fish Oil in Alleviating Cardiopulmonary Hazards Associated With Air Pollution
Actual Study Start Date : September 9, 2017
Actual Primary Completion Date : January 13, 2018
Actual Study Completion Date : January 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Air Pollution
Drug Information available for: Fish oil

Arm Intervention/treatment
Experimental: Fish oil supplementation
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
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)].

Placebo Comparator: Sunflower seed oil supplementation
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
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.




Primary Outcome Measures :
  1. Change in biomarkers of oxidative stress [ Time Frame: Venous blood,buccal sample, and saliva sample are obtained at week 1 before supplementation,and week 8,week 10, week 12 as well as week 14 during the supplementation phase. ]
    The biomarkers of oxidative stress, for example total antioxidant capacity (T-AOC), superoxide dismutase(SOD), glutathione peroxidase(GSH-Px), malonaldehyde(MDA), oxidized LDL(Ox-LDL), malondialdehyde (MDA),8-Hydroxy-deoxyguanosine (8-OHdG) and 8-isoprostane,will be measured.


Secondary Outcome Measures :
  1. Change in biomarkers of inflammation,coagulation,and endothelial function [ Time Frame: Venous blood,buccal sample,saliva sample and skin tape stripping are obtained at week 1 before supplementation,and week 8,week 10, week 12 as well as week 14 during the supplementation phase. ]
    The inflammatory biomarkers, for example interleukin-6,interleukin-8, interleukin-1b, tumor necrosis factor alpha (TNF-α) and C-reactive protein (CRP). The biomarkers of coagulation include von Willebrand factor (vWF)and fibrinogen. The biomarkers of endothelial function include endothelin-1 and eNOS and so on, well be measured.

  2. Change in pulmonary function [ Time Frame: Pulmonary function is measured at week 1 before supplementation,and week 8,week 10, week 12 as well as week 14 during the supplementation phase. ]
    The pulmonary function includes forced vital capacity(FVC), forced expiratory volume in 1 s (FEV1) and peak expiratory flow (PEF).

  3. Change in blood pressure [ Time Frame: Blood pressure is measured at week 1 before supplementation,and week 8,week 10, week 12 as well as week 14 during the supplementation phase. ]
    The investigators evaluate systolic blood pressure (SBP),diastolic blood pressure (DBP) and pulse pressure (PP, the difference of SBP and DBP).

  4. Change in stress hormone levels [ Time Frame: Venous blood samples are obtained at week 1 before supplementation,and week 8,week 10, week 12 as well as week 14 during the supplementation phase. ]
    The stress hormones,including cortisol,epinephrine,norepinephrine,serotonin, dopamine,adrenocorticotropic hormone (ACTH) and corticotropin-releasing hormone(CRH),will be measured.


Other Outcome Measures:
  1. Change in DNA and RNA [ Time Frame: Venous blood,buccal sample,and saliva sample are obtained at week 1 before supplementation,and week 8,week 10, week 12 as well as week 14 during the supplementation phase. ]
    The outcomes for example DNA Methylation and RNA will be measured.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 27 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255187


Locations
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China, Shanghai
Department of Environmental Health, School of Public Health, Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
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Study Director: Haidong Kan School of Public Health, Fudan University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Haidong Kan, PhD and Professor, Fudan University
ClinicalTrials.gov Identifier: NCT03255187     History of Changes
Other Study ID Numbers: FDUEH-3
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haidong Kan, Fudan University:
Biomarker
Fish oil
Oxidative stress
Air pollution
Cardiopulmonary system

Additional relevant MeSH terms:
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Inflammation
Pathologic Processes