## Protocol Section
### Identification Module
**NCT ID:** NCT06437119

**Brief Title:** The Antagonistic Effect of Plant Nutrients on Health Damage Caused by Environmental Pollutants

**Official Title:** A Randomized Double-blind Controlled Trial Study on the Antagonistic Effect of Plant Nutrients on Health Damage Caused by Environmental Pollutants

#### Organization Study ID Info
**ID:** IRB#2024-03-1102
#### Organization
**Class:** OTHER
**Full Name:** Fudan University
### Status Module
#### Completion Date
**Date:** 2024-08-01

**Type:** ESTIMATED

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

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-25

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Amway (China) Daily-Use Commodity Co.,Ltd

#### Lead Sponsor

**Class:** OTHER

**Name:** Fudan University

#### Responsible Party

**Investigator Affiliation:** Fudan University

**Investigator Full Name:** Ruihua Dong

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The study attempts to conduct randomized controlled trials to understand whether daily exposure to environmental pollutants can cause harm to human health, explore whether the intake of plant nutritional supplements can alleviate potential health hazards caused by environmental pollutants, and provide scientific basis for the prevention and treatment of health hazards caused by environmental pollutant exposure.

### Conditions Module

**Conditions:**

- Intestinal Functional Disorder

- Inflammation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Subjects were stratified by gender using SAS 9.3 (SAS Institute Inc. NC, US). Eligible subjects were randomly assigned equally to one of the two survey groups based on a computer-generated randomization list. The generated random list is verified by statisticians and kept confidential during the study period. The random list is kept in a separate envelope.

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** The on-site implementation personnel and those responsible for coordinating the study only received the study number of the subjects, and were unaware of the intervention group allocation of the subjects. The subjects were also unaware of their intervention allocation. A copy of the sealed envelope of the non blinded study number for each subject is provided only to the study supervisor. Before the completion of data collection, the investigators and researchers kept the blind method for treatment allocation. All subjects were monitored in a double-blind way throughout the study period, and the subjects could not distinguish their own grouping by asking questions or from appearance and texture.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 103

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The compound plant nutrients include extracts of licorice, sophora, wild cherry berry, dendrobium officinale, and pomegranate. They should be taken three times a day, one pack at a time, brewed and dissolved in warm water, and taken with meals or after meals.

**Intervention Names:**

- Dietary Supplement: Compound plant nutrients

**Label:** Nutrition supplement group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** A placebo with an indistinguishable appearance and color. 3 times a day, 1 pack at a time, dissolve in warm water and take with meals or after meals.

**Intervention Names:**

- Dietary Supplement: placebo

**Label:** placebo group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Nutrition supplement group

**Description:** The compound plant nutrients include extracts of licorice, sophora, wild cherry berry, dendrobium officinale, and pomegranate.

**Name:** Compound plant nutrients

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- placebo group

**Description:** A placebo with an indistinguishable appearance and color.

**Name:** placebo

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Py GC/MS method for detecting microplastic (MPs) levels in feces of research subjects.

**Measure:** Fecal microplastics (MPs) levels

**Time Frame:** up to 2 months

**Measure:** Fecal metagenomic sequencing

**Time Frame:** up to 2 months

**Description:** ELISA detection of MCP-1 abundance in the blood of research subjects

**Measure:** MCP-1

**Time Frame:** up to 2 months

**Description:** ELISA detection of IL-1β abundance in the blood of research subjects

**Measure:** IL-1β

**Time Frame:** up to 2 months

**Description:** ELISA detection of IL-6 abundance in the blood of research subjects

**Measure:** IL-6

**Time Frame:** up to 2 months

**Description:** ELISA detection of TNF-α abundance in the blood of research subjects

**Measure:** TNF-α

**Time Frame:** up to 2 months

**Measure:** PBMC single-cell sequencing analysis

**Time Frame:** up to 2 months

#### Secondary Outcomes

**Description:** Determine Red blood cell count (RBC) through blood routine examination

**Measure:** Red blood cell count (RBC)

**Time Frame:** up to 1 months

**Description:** Determine White blood cell count (WBC) through blood routine examination

**Measure:** White blood cell count (WBC)

**Time Frame:** up to 1 months

**Description:** Determine Lymphocyte count through blood routine examination

**Measure:** Lymphocyte count

**Time Frame:** up to 1 months

**Description:** Determine urinary protein through Urinalysis

**Measure:** urinary protein

**Time Frame:** up to 2 months

**Description:** Determine urine cast through Urinalysis

**Measure:** urine cast

**Time Frame:** up to 2 months

**Description:** Measure blood creatinine and urine creatinine, and calculate creatinine clearance rate based on this

**Measure:** creatinine clearance rate

**Time Frame:** up to 2 months

**Description:** Measuring plasma albumin content to evaluate liver function

**Measure:** albumin

**Time Frame:** up to 2 months

**Description:** Measuring aspartate aminotransferase content to evaluate liver function

**Measure:** aspartate aminotransferase

**Time Frame:** up to 2 months

**Description:** Measuring aspartate aminotransferase content to evaluate liver function

**Measure:** alanine aminotransferase

**Time Frame:** up to 2 months

**Description:** Measuring total bilirubin to evaluate liver function

**Measure:** total bilirubin

**Time Frame:** up to 2 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Volunteers aged 18-65,
* BMI\<35 kg/m2,
* agreed and signed an informed consent form.

Exclusion Criteria:

* Suffering from known congenital or acquired immunodeficiency diseases, allergic diseases, gastrointestinal diseases, and other acute and chronic diseases that require treatment;
* Within one month before the experiment, use immunosuppressive drugs, antibiotics, probiotics, prebiotics, synthetic bacteria, or other drugs that are active in gastrointestinal motility;
* Consume nutritional supplements within one month before the experiment;
* Basic medical history (hypertension, diabetes); Having bad habits (smoking, drinking);
* Receive influenza vaccine within 12 months before the experiment;
* During pregnancy or lactation;
* Weight changes exceeding 5% within the three months prior to the experiment;
* Has been enrolled or planned to be enrolled in other studies.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ruihua_dong@fudan.edu.cn

**Name:** Ruihua Dong

**Phone:** +86 158 0065 0952

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** School of Public Health，Fudan University

**Name:** Ruihua Dong

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## 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: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T257

- Name: Pomegranate

- Relevance: LOW

- As Found: Unknown

- ID: T208

- Name: Licorice

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
