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Clinical Trial Summary

Studies have shown that disposable plastic tableware will cause harm to human health after heat exposure, which is closely related to the rapid development of modern society and economy and the accelerated pace of life. Most of the existing studies focused on the characterization of micro-nano plastic particles and organic pollutants such as bisphenol A and polycyclic aromatic hydrocarbons produced after thermal exposure of disposable plastic tableware, but did not pay sufficient attention to the potential relationship with individual health effects. In addition; Sporadic animal tests and molecular tests have verified the health hazards of disposable plastic tableware leaching solution. Based on the previous research results, we believe that the leaching solution of disposable plastic tableware at high temperature environment will disturb the intestinal flora structure, affect the intestinal metabolic profile, and produce adverse health outcomes for human intestinal health. This study intends to recruit healthy school students as research objects, and collect urine and stool samples of test subjects, in order to explore the effects of high-temperature leaching solution of disposable plastic tableware on intestinal health of adults.


Clinical Trial Description

The method of single blind randomized controlled cross trial was adopted. A total of 80 healthy adults were recruited and divided into test group and control group according to the principle of randomization. During the trial period, the experimental group used a disposable plastic cup to drink a cup of hot water boiled in a hot kettle in the morning and in the evening (reduced to room temperature, about 300mL), while the control group also used a disposable plastic cup to drink room temperature water without heat exposure. The first phase lasted for 5 working weeks, and after a one-month washout period in the middle, the experimental group and the control group crossed. The second phase of the cross-over trial also lasted 5 workweeks. A total of four medical examinations were performed throughout the trial period, before and after the first and second trials. A check-up lasts half a day. Health outcome indicators: height, weight, body composition analysis, saliva, blood pressure, blood, urine sample, stool sample indicators. Urine, feces and blood samples were collected to detect the relevant indicators in order to explore the potential mechanism of the harm of heavy metals in the hot exposure leaching solution of disposable plastic tableware to human intestinal health. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06436989
Study type Interventional
Source Zhejiang Chinese Medical University
Contact
Status Enrolling by invitation
Phase N/A
Start date March 24, 2024
Completion date December 20, 2024

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