Clinical trial NCT05278910: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammation
Lead sponsor: Academia Sinica, Taiwan
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in HRV
timeFrame: baseline and 2 months later
measure: Change in pulmonary functions (TLC)
timeFrame: baseline and 2 months later
measure: Change in pulmonary functions (FVC)
timeFrame: baseline and 2 months later
measure: Change in pulmonary functions (FEV1)
timeFrame: baseline and 2 months later
measure: Change in pulmonary functions (PEF)
timeFrame: baseline and 2 months later
measure: Change in pulmonary functions (FEF)
timeFrame: baseline and 2 months later
measure: Change in oxidative stress marker
timeFrame: baseline and 2 months later
measure: Change from baseline in concentrations of inflammatory markers
timeFrame: baseline and 2 months later
Secondary outcomes:
measure: Change in blood cell count
timeFrame: baseline and 2 months later
measure: Change in blood cholesterol markers
timeFrame: baseline and 2 months later
measure: Change in blood sugar (HbA1C)
timeFrame: baseline and 2 months later
measure: Change in blood sugar (glucose)
timeFrame: baseline and 2 months later
measure: Change in liver function
timeFrame: baseline and 2 months later
measure: Change in kidney function
timeFrame: baseline and 2 months later
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Biomedical Sciences, Academia Sinica
name: Wen-Harn Pan, PhD
role: PRINCIPAL_INVESTIGATOR
References: