Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06436989
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-31
First Post:
2024-05-06
Brief Title:
Effect of Temperature Leaching Solution of Disposable Plastic Tableware on Intestinal Health of Adults
Sponsor:
Xiang Zeng
Organization:
Zhejiang Chinese Medical University
Study Overview
Official Title:
Effect of Temperature Leaching Solution of Disposable Plastic Tableware on Intestinal Health of Adults
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None