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Innovative Methods to Reduce Emissions and Health Impacts of Deep-frying

Primary Purpose

Inflammation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Soybean oil + Roasted wheat flour
Fish oil + Roasted wheat flour
Soybean oil + Vegetable and fruit extracts
Fish oil + Vegetable and fruit extracts
Sponsored by
Academia Sinica, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Exclusion Criteria:

  1. Acute diseases in the past 2 weeks
  2. Taking anti-oxidant supplements in the past month
  3. Taking steroid or non-steroidal anti-inflammatory drugs (such as Aspirin and Panadol) in the past week
  4. Under hormone replacement therapy
  5. Cancer and other severe diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Soybean oil + Roasted wheat flour

    Fish oil + Roasted wheat flour

    Soybean oil + Vegetable and fruit extracts

    Fish oil + Vegetable and fruit extracts

    Arm Description

    Assign soybean oil capsule and roasted wheat flour.

    Assign fish oil capsule and roasted wheat flour.

    Assign soybean oil capsule and Vegetable and fruit extracts.

    Assign fish oil capsule and Vegetable and fruit extracts.

    Outcomes

    Primary Outcome Measures

    Change in HRV
    Change in heart rate variability (HRV)
    Change in pulmonary functions (TLC)
    Change in TLC in L
    Change in pulmonary functions (FVC)
    Change in FVC in L
    Change in pulmonary functions (FEV1)
    Change in FEV1 in L
    Change in pulmonary functions (PEF)
    Change in PEF in L/sec
    Change in pulmonary functions (FEF)
    Change in FEF in L/sec
    Change in oxidative stress marker
    Change in urinary 8-OHdG for DNA damage
    Change from baseline in concentrations of inflammatory markers
    Inflammatory markers include IL-1β, IL-2, IL-4, IL-6, IL-10, IL-12, IL-13, IL-17A, IL-23, IL-33, TNF- α, IFN-γ, CXCL1, CXCL9, and CXCL10 (IP-10) in blood

    Secondary Outcome Measures

    Change in blood cell count
    Blood cell count is measured by Completed Blood Count Test
    Change in blood cholesterol markers
    Blood cholesterol markers include HDL in mg/dL, LDL in mg/dL, TG in mg/dL and total cholesterol in mg/dL
    Change in blood sugar (HbA1C)
    Change in HbA1C in %
    Change in blood sugar (glucose)
    Change in glucose in mg/dL
    Change in liver function
    The markers of liver function include GOT in U/L and GPT in U/L
    Change in kidney function
    The markers of kidney function include creatinine in mg/dL, uric acid in mg/dL, BUN in mg/dL, microalbumin in mg/dL

    Full Information

    First Posted
    January 16, 2022
    Last Updated
    March 10, 2022
    Sponsor
    Academia Sinica, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05278910
    Brief Title
    Innovative Methods to Reduce Emissions and Health Impacts of Deep-frying
    Official Title
    Innovative Methods to Reduce Emissions and Health Impacts of Deep-frying
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 14, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Academia Sinica, Taiwan

    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
    Cooking oil fume (COF) is a significant source of PM2.5 for poorly ventilated space indoors and in urban streets near restaurants or night markets. Modern Chinese cooking produces high concentration of COF especially from deep-frying foods and stirred frying. Emission from high-temperature frying has been classified by the IARC as Group 2A carcinogen. Cooks are at high risk of exposure to toxic compounds from cooking fumes. However, more of the COF-related studies focused on the home kitchen and less addresses the problems in the restaurants. Studying health hazards and biomarkers of cooks may provide opportunities to understand biological mechanisms and to search and test efficacy for measures to overturn such risks. The investigators will recruit 80 cooks who handle deep-frying and stirred frying on daily basis. The 80 cooks will be randomized to 4 groups: (1) control, (2) vegetable and fruits extract (V&F) group, (3) fish oil group, and (4) V&F-fish oil group will be provided to the participants for 2 months V&F capsules (equivalent to 4 servings a day) and fish oil capsules (1~1.5 serving a day) and placebos of the same appearance. Heart rate variability (HRV), pulmonary functions, bio-markers, oxylipins and metabolomics profile will be measured as outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Soybean oil + Roasted wheat flour
    Arm Type
    Placebo Comparator
    Arm Description
    Assign soybean oil capsule and roasted wheat flour.
    Arm Title
    Fish oil + Roasted wheat flour
    Arm Type
    Experimental
    Arm Description
    Assign fish oil capsule and roasted wheat flour.
    Arm Title
    Soybean oil + Vegetable and fruit extracts
    Arm Type
    Experimental
    Arm Description
    Assign soybean oil capsule and Vegetable and fruit extracts.
    Arm Title
    Fish oil + Vegetable and fruit extracts
    Arm Type
    Experimental
    Arm Description
    Assign fish oil capsule and Vegetable and fruit extracts.
    Intervention Type
    Other
    Intervention Name(s)
    Soybean oil + Roasted wheat flour
    Intervention Description
    Assign soybean oil capsule and roasted wheat flour
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Fish oil + Roasted wheat flour
    Intervention Description
    Assign fish oil and roasted wheat flour
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Soybean oil + Vegetable and fruit extracts
    Intervention Description
    Assign soybean oil and vegetable and fruit extracts
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Fish oil + Vegetable and fruit extracts
    Intervention Description
    Assign fish oil and vegetable and fruit extracts
    Primary Outcome Measure Information:
    Title
    Change in HRV
    Description
    Change in heart rate variability (HRV)
    Time Frame
    baseline and 2 months later
    Title
    Change in pulmonary functions (TLC)
    Description
    Change in TLC in L
    Time Frame
    baseline and 2 months later
    Title
    Change in pulmonary functions (FVC)
    Description
    Change in FVC in L
    Time Frame
    baseline and 2 months later
    Title
    Change in pulmonary functions (FEV1)
    Description
    Change in FEV1 in L
    Time Frame
    baseline and 2 months later
    Title
    Change in pulmonary functions (PEF)
    Description
    Change in PEF in L/sec
    Time Frame
    baseline and 2 months later
    Title
    Change in pulmonary functions (FEF)
    Description
    Change in FEF in L/sec
    Time Frame
    baseline and 2 months later
    Title
    Change in oxidative stress marker
    Description
    Change in urinary 8-OHdG for DNA damage
    Time Frame
    baseline and 2 months later
    Title
    Change from baseline in concentrations of inflammatory markers
    Description
    Inflammatory markers include IL-1β, IL-2, IL-4, IL-6, IL-10, IL-12, IL-13, IL-17A, IL-23, IL-33, TNF- α, IFN-γ, CXCL1, CXCL9, and CXCL10 (IP-10) in blood
    Time Frame
    baseline and 2 months later
    Secondary Outcome Measure Information:
    Title
    Change in blood cell count
    Description
    Blood cell count is measured by Completed Blood Count Test
    Time Frame
    baseline and 2 months later
    Title
    Change in blood cholesterol markers
    Description
    Blood cholesterol markers include HDL in mg/dL, LDL in mg/dL, TG in mg/dL and total cholesterol in mg/dL
    Time Frame
    baseline and 2 months later
    Title
    Change in blood sugar (HbA1C)
    Description
    Change in HbA1C in %
    Time Frame
    baseline and 2 months later
    Title
    Change in blood sugar (glucose)
    Description
    Change in glucose in mg/dL
    Time Frame
    baseline and 2 months later
    Title
    Change in liver function
    Description
    The markers of liver function include GOT in U/L and GPT in U/L
    Time Frame
    baseline and 2 months later
    Title
    Change in kidney function
    Description
    The markers of kidney function include creatinine in mg/dL, uric acid in mg/dL, BUN in mg/dL, microalbumin in mg/dL
    Time Frame
    baseline and 2 months later

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Exclusion Criteria: Acute diseases in the past 2 weeks Taking anti-oxidant supplements in the past month Taking steroid or non-steroidal anti-inflammatory drugs (such as Aspirin and Panadol) in the past week Under hormone replacement therapy Cancer and other severe diseases
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shu-Haur Hsieh, MS
    Phone
    886-2-27899121
    Email
    d83425@ibms.sinica.edu.tw
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kuang-Mao Chiang, PhD
    Phone
    886-2-27899121
    Email
    kuangmao@ibms.sinica.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wen-Harn Pan, PhD
    Organizational Affiliation
    Institute of Biomedical Sciences, Academia Sinica
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Innovative Methods to Reduce Emissions and Health Impacts of Deep-frying

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