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

A Randomized Double-blind Controlled Trial Study on 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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Intestinal Functional Disorder
• Intervention / Treatment: Dietary supplement: Compound plant nutrients; Dietary supplement: placebo

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Xuhui
    • Shanghai, Xuhui, China, 200030
      • School of public health, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutrition supplement group; The nutrition supplement group received the composite polyphenols intervention agent. 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. The dosage was three times daily, with a total intake of 465mg of composite polyphenols. The intervention agent should be taken one sachet each time, dissolved in warm water and taken during or after meals in the morning, afternoon, and evening.	Dietary supplement: Compound plant nutrients; 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 Comparator: placebo group; The placebo group received the placebo. 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.	Dietary supplement: placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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.	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.	About 2 months
Blood glucose indicators as assessed by the Hitachi 7180 fully automatic biochemical analyzer	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.	About 2 months
Blood lipid indicators as assessed by the Hitachi 7180 fully automatic biochemical analyzer	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.	about 2 months
Routine blood examination as assessed by the Dima DH36X fully automatic blood cell analyzer	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	About 1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Red blood cell count (RBC)	Determine Red blood cell count (RBC) through blood routine examination	up to 1 months
White blood cell count (WBC)	Determine White blood cell count (WBC) through blood routine examination	up to 1 months
Lymphocyte count	Determine Lymphocyte count through blood routine examination	up to 1 months
urinary protein	Determine urinary protein through Urinalysis	up to 2 months
urine cast	Determine urine cast through Urinalysis	up to 2 months
creatinine clearance rate	Measure blood creatinine and urine creatinine, and calculate creatinine clearance rate based on this	up to 2 months
albumin	Measuring plasma albumin content to evaluate liver function	up to 2 months
aspartate aminotransferase	Measuring aspartate aminotransferase content to evaluate liver function	up to 2 months
alanine aminotransferase	Measuring aspartate aminotransferase content to evaluate liver function	up to 2 months
total bilirubin	Measuring total bilirubin to evaluate liver function	up to 2 months

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Amway (China) Daily-Use Commodity Co.,Ltd
• Investigators: Principal Investigator: Ruihua Dong, School of Public Health，Fudan University

Publications and helpful links

General Publications

• Zhao L, Zheng J, Shen Y, Xu X, Liu X, Yu J, Li J, Yang B, Chen L, Wang F, Liu S, Peng X, Du J, Dong R. Composite polyphenols mitigate microplastic exposure-related immune disturbances: a two-phase population trial. Nat Commun. 2026 Apr 3. doi: 10.1038/s41467-026-71167-8. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 25, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation
• Other Study ID Numbers: IRB#2024-03-1102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No