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

NCT06436989 | Enrolling By Invitation

• 1 other identifier: 20240306-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Dysfunction; Inflammation

Outcome Measures

Primary Outcomes (2)

• Forced Vital Capacity(FVC)

  We plan to measure forced vital capacity (FVC) of lung function.

  Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage

• Blood Pressure(BP)

  We plan to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP)

  Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage.

Secondary Outcomes (1)

• 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.

Other Outcomes (1)

• 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.

Study Arms (2)

hot water

EXPERIMENTAL

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

Other: hot purified water

normal temperature water

PLACEBO COMPARATOR

300 ml pure water without any treatment

Other: hot purified water

Interventions

hot purified water OTHER

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

hot water; normal temperature water

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiang Zeng: lead

Study Sites (1)

Zhejiang Chinese Medicine University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 31, 2024
• Study Start: March 24, 2024
• Primary Completion: June 13, 2024
• Study Completion: December 20, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

CN (1)