The Antagonistic Effect of Plant Nutrients on Health Damage Caused by Environmental Pollutants

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06437119
• Other study ID #: IRB#2024-03-1102
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Fudan University
• Contact: Ruihua Dong
• Phone: +86 158 0065 0952
• Email: ruihua_dong[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 103
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation

Intervention

Dietary Supplement:
• Compound plant nutrients
The compound plant nutrients include extracts of licorice, sophora, wild cherry berry, dendrobium officinale, and pomegranate.
• placebo
A placebo with an indistinguishable appearance and color.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Amway (China) Daily-Use Commodity Co.,Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal microplastics (MPs) levels	Py GC/MS method for detecting microplastic (MPs) levels in feces of research subjects.	up to 2 months
Primary	Fecal metagenomic sequencing		up to 2 months
Primary	MCP-1	ELISA detection of MCP-1 abundance in the blood of research subjects	up to 2 months
Primary	IL-1ß	ELISA detection of IL-1ß abundance in the blood of research subjects	up to 2 months
Primary	IL-6	ELISA detection of IL-6 abundance in the blood of research subjects	up to 2 months
Primary	TNF-a	ELISA detection of TNF-a abundance in the blood of research subjects	up to 2 months
Primary	PBMC single-cell sequencing analysis		up to 2 months
Secondary	Red blood cell count (RBC)	Determine Red blood cell count (RBC) through blood routine examination	up to 1 months
Secondary	White blood cell count (WBC)	Determine White blood cell count (WBC) through blood routine examination	up to 1 months
Secondary	Lymphocyte count	Determine Lymphocyte count through blood routine examination	up to 1 months
Secondary	urinary protein	Determine urinary protein through Urinalysis	up to 2 months
Secondary	urine cast	Determine urine cast through Urinalysis	up to 2 months
Secondary	creatinine clearance rate	Measure blood creatinine and urine creatinine, and calculate creatinine clearance rate based on this	up to 2 months
Secondary	albumin	Measuring plasma albumin content to evaluate liver function	up to 2 months
Secondary	aspartate aminotransferase	Measuring aspartate aminotransferase content to evaluate liver function	up to 2 months
Secondary	alanine aminotransferase	Measuring aspartate aminotransferase content to evaluate liver function	up to 2 months
Secondary	total bilirubin	Measuring total bilirubin to evaluate liver function	up to 2 months