跳至主要内容
临床试验/NCT05278910
NCT05278910尚未招募不适用

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

Academia Sinica, Taiwan0 个研究点目标入组 80 人开始时间: 2022年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
主要终点
Change in HRV

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in HRV

时间窗: baseline and 2 months later

Change in heart rate variability (HRV)

Change in pulmonary functions (TLC)

时间窗: baseline and 2 months later

Change in TLC in L

Change in pulmonary functions (FVC)

时间窗: baseline and 2 months later

Change in FVC in L

Change in pulmonary functions (FEV1)

时间窗: baseline and 2 months later

Change in FEV1 in L

Change from baseline in concentrations of inflammatory markers

时间窗: baseline and 2 months later

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

Change in pulmonary functions (PEF)

时间窗: baseline and 2 months later

Change in PEF in L/sec

Change in oxidative stress marker

时间窗: baseline and 2 months later

Change in urinary 8-OHdG for DNA damage

Change in pulmonary functions (FEF)

时间窗: baseline and 2 months later

Change in FEF in L/sec

次要结局

  • Change in blood cholesterol markers(baseline and 2 months later)
  • Change in liver function(baseline and 2 months later)
  • Change in kidney function(baseline and 2 months later)
  • Change in blood sugar (HbA1C)(baseline and 2 months later)
  • Change in blood cell count(baseline and 2 months later)
  • Change in blood sugar (glucose)(baseline and 2 months later)

研究者

发起方
Academia Sinica, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen-Harn Pan

Distinguished Research Fellow, Principal Investigator

Academia Sinica, Taiwan

相似试验

Innovative Methods to Reduce Emissions and Health... | 临床试验