The Antagonistic Effect of Composite Polyphenols on Health Damage Caused by Environmental Pollutants

Fudan University98 enrolled

Overview

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 composite polyphenols 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Intestinal Functional Disorder Inflammation

Interventions

Compound plant nutrientsDIETARY_SUPPLEMENT

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

placeboDIETARY_SUPPLEMENT

A placebo with an indistinguishable appearance and color.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1\. Participants aged 18-65 years; 2. Body mass index (BMI) \< 35 kg/m²; 3. On-campus residence for one year and no need to leave the province during the trial period; 4. Agreeing to and signing the informed consent form. Exclusion Criteria: 1.Documented diagnosis of congenital or acquired immunodeficiency disorders, allergic diseases, gastrointestinal pathologies, or other acute/chronic conditions requiring therapeutic intervention; 2.Administration of immunosuppressive agents, antibiotics, probiotics, prebiotics, synbiotics, or gastrointestinal motility-active medications within three months prior to the trial; 3.Consumption of nutritional supplements within three months preceding the study; 4.Underlying disease, including hypertension or diabetes mellitus; 5.Habitual substance use (tobacco smoking or alcohol consumption); 6.Influenza vaccination within 12 months prior to the trial; 7.pregnancy or lactation status; 8.Body weight fluctuation exceeding 5% within three months before the study; 9.Concurrent or planned enrollment in alternative clinical investigations.

Locations (1)

School of Public Health, Fudan University

Shanghai, Xuhui, China

Outcomes

Primary Outcomes

Fecal microplastics (MPs) levels as assessed by Py-GC/MS

Py-GC/MS method for detecting microplastic (MPs) levels in feces of research subjects. The concentration of fecal microplastics will be reported in units of μ g/g dry weight (μ g/g dw)

Time frame: up to 2 months

Fecal metagenomic sequencing as sequenced using the Illumina NovaSeq/HiSeq Xten platform

DNA was extracted from fecal samples using the FastPure Stool DNA Isolation Kit (Magnetic bead) (MJYH, Shanghai, China). The DNA fragments were amplified via bridge PCR and sequenced using the Illumina NovaSeq/HiSeq Xten platform (Illumina, USA). Raw data were processed using Fastp and BWA software for quality control and removal of host DNA sequences. The abundance of genes in each sample was described using RPKM.

Time frame: up to 2 months

Blood Metabolomics as assessed by UPLC-TripleTOF

The pretreated samples were analyzed using an Ultra-high Performance Liquid Chromatography with quadrupole time-of-flight mass spectrometry (UPLC-TripleTOF) system (AB SCIEX). The samples were separated using a BEH C18 chromatography column (100 mm\*2.1 mm i.d., 1.8 µm) and detected via mass spectrometry. The mass spectrometry signal was acquired in positive and negative ion scanning modes, with a mass-to-charge ratio (m/z) range of 50-1000. Raw data were imported into the Progenesis QI software (Waters Corporation, Milford, USA) for processing, generating a data matrix containing retention time, m/z, and peak intensity. The MS and MS/MS spectra were matched with the HMDB (http://www.hmdb.ca/) and Metlin (https://metlin.scripps.edu/) databases to identify metabolites.

Time frame: About 2 months

Inflammatory cytokines as assesed by Luminex technology

The levels of 10 inflammatory cytokines in blood plasma samples were detected using Luminex technology, including IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, and IFN-γ. Inflammatory cytokine indicators are described in pg/ml units.

Time frame: About 2 months

Data from ClinicalTrials.gov

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