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
About this trial
This is an interventional treatment trial for Inflammation
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
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
NCT ID
NCT05278910
First Posted
January 16, 2022
Last Updated
March 10, 2022
Sponsor
Academia Sinica, Taiwan
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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