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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammation
• Intervention / Treatment: Other: Soybean oil + Roasted wheat flour; Dietary supplement: Fish oil + Roasted wheat flour; Dietary supplement: Soybean oil + Vegetable and fruit extracts; Dietary supplement: Fish oil + Vegetable and fruit extracts

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shu-Haur Hsieh, MS; Phone Number: 886-2-27899121; Email: d83425@ibms.sinica.edu.tw
• Study Contact Backup: Name: Kuang-Mao Chiang, PhD; Phone Number: 886-2-27899121; Email: kuangmao@ibms.sinica.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Soybean oil + Roasted wheat flour; Assign soybean oil capsule and roasted wheat flour.	Other: Soybean oil + Roasted wheat flour; Assign soybean oil capsule and roasted wheat flour
Experimental: Fish oil + Roasted wheat flour; Assign fish oil capsule and roasted wheat flour.	Dietary supplement: Fish oil + Roasted wheat flour; Assign fish oil and roasted wheat flour
Experimental: Soybean oil + Vegetable and fruit extracts; Assign soybean oil capsule and Vegetable and fruit extracts.	Dietary supplement: Soybean oil + Vegetable and fruit extracts; Assign soybean oil and vegetable and fruit extracts
Experimental: Fish oil + Vegetable and fruit extracts; Assign fish oil capsule and Vegetable and fruit extracts.	Dietary supplement: Fish oil + Vegetable and fruit extracts; Assign fish oil and vegetable and fruit extracts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HRV	Change in heart rate variability (HRV)	baseline and 2 months later
Change in pulmonary functions (TLC)	Change in TLC in L	baseline and 2 months later
Change in pulmonary functions (FVC)	Change in FVC in L	baseline and 2 months later
Change in pulmonary functions (FEV1)	Change in FEV1 in L	baseline and 2 months later
Change in pulmonary functions (PEF)	Change in PEF in L/sec	baseline and 2 months later
Change in pulmonary functions (FEF)	Change in FEF in L/sec	baseline and 2 months later
Change in oxidative stress marker	Change in urinary 8-OHdG for DNA damage	baseline and 2 months later
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	baseline and 2 months later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood cell count	Blood cell count is measured by Completed Blood Count Test	baseline and 2 months later
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	baseline and 2 months later
Change in blood sugar (HbA1C)	Change in HbA1C in %	baseline and 2 months later
Change in blood sugar (glucose)	Change in glucose in mg/dL	baseline and 2 months later
Change in liver function	The markers of liver function include GOT in U/L and GPT in U/L	baseline and 2 months later
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	baseline and 2 months later

Collaborators and Investigators

• Sponsor: Academia Sinica, Taiwan
• Investigators: Principal Investigator: Wen-Harn Pan, PhD, Institute of Biomedical Sciences, Academia Sinica

Study record dates

Study Major Dates

• Study Start (Anticipated): March 14, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 16, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: AS-IRB01-21006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No