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

NCT05278910 | Unknown

• 1 other identifier: AS-IRB01-21006
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammation

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Change in blood cell count

  baseline and 2 months later

• Change in blood cholesterol markers

  baseline and 2 months later

• Change in blood sugar (HbA1C)

  baseline and 2 months later

• Change in blood sugar (glucose)

  baseline and 2 months later

• Change in liver function

  baseline and 2 months later

Study Arms (4)

Soybean oil + Roasted wheat flour

PLACEBO COMPARATOR

Assign soybean oil capsule and roasted wheat flour.

Other: Soybean oil + Roasted wheat flour

Fish oil + Roasted wheat flour

EXPERIMENTAL

Assign fish oil capsule and roasted wheat flour.

Dietary Supplement: Fish oil + Roasted wheat flour

Soybean oil + Vegetable and fruit extracts

EXPERIMENTAL

Assign soybean oil capsule and Vegetable and fruit extracts.

Dietary Supplement: Soybean oil + Vegetable and fruit extracts

Fish oil + Vegetable and fruit extracts

EXPERIMENTAL

Assign fish oil capsule and Vegetable and fruit extracts.

Dietary Supplement: Fish oil + Vegetable and fruit extracts

Interventions

Soybean oil + Roasted wheat flour OTHER

Assign soybean oil capsule and roasted wheat flour

Soybean oil + Roasted wheat flour

Fish oil + Roasted wheat flour DIETARY_SUPPLEMENT

Assign fish oil and roasted wheat flour

Fish oil + Roasted wheat flour

Soybean oil + Vegetable and fruit extracts DIETARY_SUPPLEMENT

Assign soybean oil and vegetable and fruit extracts

Soybean oil + Vegetable and fruit extracts

Fish oil + Vegetable and fruit extracts DIETARY_SUPPLEMENT

Assign fish oil and vegetable and fruit extracts

Fish oil + Vegetable and fruit extracts

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Academia Sinica, Taiwan: lead

MeSH Terms

Conditions

Inflammation

Interventions

Soybean Oil; Fish Oils; Vegetables

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Wen-Harn Pan, PhD

  Institute of Biomedical Sciences, Academia Sinica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Haur Hsieh, MS

CONTACT

886-2-27899121; d83425@ibms.sinica.edu.tw

Kuang-Mao Chiang, PhD

CONTACT

886-2-27899121; kuangmao@ibms.sinica.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Research Fellow, Principal Investigator

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: March 14, 2022
• Study Start: March 14, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 14, 2022

Record last verified: 2022-03