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Completed

NCT Number: NCT06437119

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

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.

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Key information

Conditions

Intestinal Functional Disorder Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Public Health, Fudan University

Shanghai, Xuhui, 200030, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Compound plant nutrients

Dietary Supplement

The main active components of the composite polyphenols intervention agent include a mixture of 43 types of polyphenols. The composite polyphenols intervention agent is powders encapsulated in sachets, each containing 155 mg composite polyphenols.

Placebo

Dietary Supplement

The placebo mainly consists of resistant dextrin and erythritol. Apart from the contents, the appearance, color, and consumption method of the placebo are the same as those of the intervention agent. Participants were not informed of their group allocation in any way.

Primary outcomes

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

    Time frame: up to 2 months

    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)

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

    Time frame: up to 2 months

    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.

  3. Blood Metabolomics as assessed by UPLC-TripleTOF

    Time frame: About 2 months

    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.

  4. Inflammatory cytokines as assesed by Luminex technology

    Time frame: About 2 months

    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.

  5. Blood glucose indicators as assessed by the Hitachi 7180 fully automatic biochemical analyzer

    Time frame: About 2 months

    Using the Hitachi 7180 fully automatic biochemical analyzer to measure glucose (glycated serum protein, GSP; glucose, GLU) indicators. Blood glucose indicators are described in mmol/l units.

  6. Blood lipid indicators as assessed by the Hitachi 7180 fully automatic biochemical analyzer

    Time frame: about 2 months

    Using the Hitachi 7180 fully automatic biochemical analyzer to measure lipid (total cholesterol, CHO; triglycerides, TG; high-density lipoprotein cholesterol, HDL; low-density lipoprotein cholesterol, LDL) indicators. Blood lipid indicators are described in mmol/l units.

  7. Routine blood examination as assessed by the Dima DH36X fully automatic blood cell analyzer

    Time frame: About 1 months

    Using the Dima DH36X fully automatic blood cell analyzer for routine blood examination (three-part differential). We measured the white blood cell count (WBC), lymphocyte count (LYM), monocyte count (MXD), and neutrophil count (NEU) in the blood routine and reported them in units of 10 * 9 cells/L

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • Amway (China) Daily-Use Commodity Co.,Ltd

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 31, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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