## Protocol Section
### Identification Module
**NCT ID:** NCT06436989

**Brief Title:** Effect of Temperature Leaching Solution of Disposable Plastic Tableware on Intestinal Health of Adults

**Official Title:** Effect of Temperature Leaching Solution of Disposable Plastic Tableware on Intestinal Health of Adults

#### Organization Study ID Info
**ID:** 20240306-1
#### Organization
**Class:** OTHER_GOV
**Full Name:** Zhejiang Chinese Medical University
### Status Module
#### Completion Date
**Date:** 2024-12-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-06-13

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-24

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Xiang Zeng

#### Responsible Party

**Investigator Affiliation:** Zhejiang Chinese Medical University

**Investigator Full Name:** Xiang Zeng

**Investigator Title:** Associate professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Intestinal Dysfunction

- Inflammation

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: hot purified water

**Label:** hot water

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 300 ml pure water without any treatment

**Intervention Names:**

- Other: hot purified water

**Label:** normal temperature water

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- hot water

- normal temperature water

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

**Name:** hot purified water

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** We plan to measure serum concentrations of C-reactive protein(CRP)

**Measure:** C-reactive protein(CRP)

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

#### Primary Outcomes

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

**Measure:** Forced Vital Capacity(FVC)

**Time Frame:** Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage

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

**Measure:** Blood Pressure(BP)

**Time Frame:** 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

**Description:** We plan to measure Heart Rate Variability (HRV).

**Measure:** Heart Rate Variability(HRV)

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

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hangzhou

**Country:** China

**Facility:** Zhejiang Chinese Medicine University

**State:** Zhejiang

**Zip:** 310000

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

### Condition Browse Module - Meshes

- ID: D000007249

- Term: Inflammation

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
