Clinical trial NCT06437119: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intestinal Functional Disorder
Inflammation
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Amway (China) Daily-Use Commodity Co.,Ltd
First posted: 2024-05-31
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Fecal microplastics (MPs) levels
timeFrame: up to 2 months
measure: Fecal metagenomic sequencing
timeFrame: up to 2 months
measure: MCP-1
timeFrame: up to 2 months
measure: IL-1β
timeFrame: up to 2 months
measure: IL-6
timeFrame: up to 2 months
measure: TNF-α
timeFrame: up to 2 months
measure: PBMC single-cell sequencing analysis
timeFrame: up to 2 months
Secondary outcomes:
measure: Red blood cell count (RBC)
timeFrame: up to 1 months
measure: White blood cell count (WBC)
timeFrame: up to 1 months
measure: Lymphocyte count
timeFrame: up to 1 months
measure: urinary protein
timeFrame: up to 2 months
measure: urine cast
timeFrame: up to 2 months
measure: creatinine clearance rate
timeFrame: up to 2 months
measure: albumin
timeFrame: up to 2 months
measure: aspartate aminotransferase
timeFrame: up to 2 months
measure: alanine aminotransferase
timeFrame: up to 2 months
measure: total bilirubin
timeFrame: up to 2 months
Other outcomes:
Locations:
Study officials:
affiliation: School of Public Health，Fudan University
name: Ruihua Dong
role: PRINCIPAL_INVESTIGATOR
References: