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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03255187
Recruitment Status : Completed
First Posted : August 21, 2017
Results First Posted : January 21, 2020
Last Update Posted : January 21, 2020
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. Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD) [ Time Frame: 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. ]
    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.

  2. Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α) [ Time Frame: 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. ]
    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.

  3. Cogulation Biomarker-von Willebrand Factor (vWF) [ Time Frame: 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. ]
    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.

  4. Biomarkers of Endothelial Function and Stress Hormone [ Time Frame: 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. ]
    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.

  5. Endothelial Function Biomarker-Endothelin-1(ET-1) [ Time Frame: 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. ]
    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.

  6. Cogulation Biomarker-Fibrinogen [ Time Frame: 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. ]
    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.

  7. High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker [ Time Frame: 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. ]
    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.

  8. Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker [ Time Frame: 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. ]
    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.

  9. Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity [ Time Frame: 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. ]
    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.

  10. Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: 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. ]
    After sitting in a quiet room for at least 5 min, participants had their left upper arm blood pressure measured by trained technicians using an electronic sphygmomanometer at least three times with 3-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP (SBP) and diastolic BP (DBP). If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements was arranged. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  2. Insulin Resistance [ Time Frame: 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. ]
    The biomarker of insulin resistance is measured, calculated by fasting glucose and fasting insulin using the formula of [fasting insulin (mU/L) × fasting glucose (mmol/L)]/22.5. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  3. Skin Inflammation Biomarkers [ Time Frame: 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. ]
    2 infammation biomarkers from skin samplings are measured, including interleukin-1 Alpha (IL-1α) and Interleukin-1 receptor antagonist (IL-1Rα). The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  4. Skin Oxidative Stress Biomarker-Carbonyl Protein [ Time Frame: 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. ]
    oxidative stress biomarker in skin samplings includes carbonyl protein. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  5. Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 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. ]
    Indicators of lung function include forced vital capacity (FVC) and andforced expiratory volume in 1 second (FEV1). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  6. Lung Function-Peak Expiratory Flow (PEF) [ Time Frame: 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. ]
    Additional indicator of lung function includes peak expiratory flow (PEF). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  7. Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC) [ Time Frame: 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. ]
    we measure TAC level, an antioxidant biomarker in skin samplings. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.

  8. Skin Antioxidant Biomarker-Glutataione (GSH) [ Time Frame: 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. ]
    we measure another skin antioxidant biomarker-GSH, . The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.



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
  Study Documents (Full-Text)

Documents provided by Haidong Kan, 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    
Other Study ID Numbers: FDUEH-3
First Posted: August 21, 2017    Key Record Dates
Results First Posted: January 21, 2020
Last Update Posted: January 21, 2020
Last Verified: November 2019

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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