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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05278910
• Other study ID #: AS-IRB01-21006
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2022
• Source: Academia Sinica, Taiwan
• Contact: Shu-Haur Hsieh, MS
• Phone: 886-2-27899121
• Email: d83425[@]ibms.sinica.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation

Intervention

Other:
• Soybean oil + Roasted wheat flour
Assign soybean oil capsule and roasted wheat flour

Dietary Supplement:
• Fish oil + Roasted wheat flour
Assign fish oil and roasted wheat flour
• Soybean oil + Vegetable and fruit extracts
Assign soybean oil and vegetable and fruit extracts
• Fish oil + Vegetable and fruit extracts
Assign fish oil and vegetable and fruit extracts

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Academia Sinica, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HRV	Change in heart rate variability (HRV)	baseline and 2 months later
Primary	Change in pulmonary functions (TLC)	Change in TLC in L	baseline and 2 months later
Primary	Change in pulmonary functions (FVC)	Change in FVC in L	baseline and 2 months later
Primary	Change in pulmonary functions (FEV1)	Change in FEV1 in L	baseline and 2 months later
Primary	Change in pulmonary functions (PEF)	Change in PEF in L/sec	baseline and 2 months later
Primary	Change in pulmonary functions (FEF)	Change in FEF in L/sec	baseline and 2 months later
Primary	Change in oxidative stress marker	Change in urinary 8-OHdG for DNA damage	baseline and 2 months later
Primary	Change from baseline in concentrations of inflammatory markers	Inflammatory markers include IL-1ß, IL-2, IL-4, IL-6, IL-10, IL-12, IL-13, IL-17A, IL-23, IL-33, TNF- a, IFN-?, CXCL1, CXCL9, and CXCL10 (IP-10) in blood	baseline and 2 months later
Secondary	Change in blood cell count	Blood cell count is measured by Completed Blood Count Test	baseline and 2 months later
Secondary	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
Secondary	Change in blood sugar (HbA1C)	Change in HbA1C in %	baseline and 2 months later
Secondary	Change in blood sugar (glucose)	Change in glucose in mg/dL	baseline and 2 months later
Secondary	Change in liver function	The markers of liver function include GOT in U/L and GPT in U/L	baseline and 2 months later
Secondary	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