Effect of Temperature Leaching Solution of Disposable Plastic Tableware on Intestinal Health of Adults

NCT ID: NCT06436989

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-24
• Study Completion Date: 2024-12-20

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.

Conditions

Intestinal Dysfunction; Inflammation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

hot water

300ml pure water cooled to room temperature in a kettle.

Group Type: EXPERIMENTAL

hot purified water

Intervention Type: OTHER

Hot purified water,drink once a workday,almost 360mL.Buy from regular channels.

normal temperature water

300 ml pure water without any treatment

Group Type: PLACEBO_COMPARATOR

hot purified water

Intervention Type: OTHER

Hot purified water,drink once a workday,almost 360mL.Buy from regular channels.

Interventions

hot purified water

Hot purified water,drink once a workday,almost 360mL.Buy from regular channels.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• .Healthy college students aged 18 to 35;
• .Subjects can receive the intervention in this study.

Exclusion Criteria

• 1.Have been diagnosed with diabetes, ulcerative colitis, Crohn's disease, or an infectious disease;

• Chemotherapy, radiation or surgery 3-6 months prior to sampling;
• Abnormal bowel movements one week before sampling;
• I was menstruating at the time of sampling;
• In the past three months, the sample has taken probiotics and other related health products and dietary supplements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xiang Zeng

OTHER_GOV

Sponsor Role: lead

Responsible Party

Xiang Zeng

Associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zhejiang Chinese Medicine University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

20240306-1

Identifier Type: -

Identifier Source: org_study_id