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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06436989
Enrollment
80
Registered
2024-05-31
Start date
2024-03-24
Completion date
2024-12-20
Last updated
2024-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Intestinal Dysfunction

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.

Interventions

OTHERhot purified water

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

Sponsors

Xiang Zeng
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Forced Vital Capacity(FVC)Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stageWe plan to measure forced vital capacity (FVC) of lung function.
Blood Pressure(BP)Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage.We plan to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP)

Secondary

MeasureTime frameDescription
Heart Rate Variability(HRV)Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage.We plan to measure Heart Rate Variability (HRV).

Other

MeasureTime frameDescription
C-reactive protein(CRP)Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage.We plan to measure serum concentrations of C-reactive protein(CRP)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026