Intestinal Functional DisorderNCT06437119
The Antagonistic Effect of Composite Polyphenols on Health Damage Caused by Environmental Pollutants
A study testing Compound plant nutrients in people with Intestinal Functional Disorder and Inflammation, run by Fudan University at 1 site in China.
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 composite polyphenols can alleviate potential health hazards caused by environmental pollutants, and provide scientific basis for the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Functional Disorder, Inflammation
- What is being tested?
- Compound plant nutrients
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Intestinal Functional Disorder, Inflammation
- Being tested
- Compound plant nutrients, placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound plant nutrientsDietary 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.
placeboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition supplement group | Experimental | 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. Receives: Dietary Supplement: Compound plant nutrients |
| placebo group | Placebo comparator | 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. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: About 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start23 Apr 2024
- Primary completion1 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal Functional DisorderStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random numbers were generated using IBM SPSS Statistics 26.0, with the random seed set to the date of the day. Eligible participants were sorted based on the size of the generated random numbers, with the first 50% of the ranked list assigned to the placebo group and the last 50% assigned to the intervention group. Participants were allocated randomly in equal proportions, and the random list was validated by a statistician.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Amway (China) Daily-Use Commodity Co.,Ltd
- Responsible party
- Principal investigator, Ruihua Dong, Fudan University
- Investigators
- Ruihua Dong, Principal investigator, School of Public Health，Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437119
- Sponsor's protocol ID
- IRB#2024-03-1102
- Status last verified
- Mar 2026
- First submitted
- 21 May 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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;17(1):6132. doi: 10.1038/s41467-026-71167-8.
PubMed 41932890
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Controlled Trial Study on the Antagonistic Effect of Composite Polyphenols on Health Damage Caused by Environmental Pollutants
- ClinicalTrials.gov ID
- NCT06437119
- Acronym / sponsor ID
- IRB#2024-03-1102
- Conditions
- Intestinal Functional Disorder, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Amway (China) Daily-Use Commodity Co.,Ltd
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Random numbers were generated using IBM SPSS Statistics 26.0, with the random seed set to the date of the day. Eligible participants were sorted based on the size of the generated random numbers, with the first 50% of the ranked list assigned to the placebo group and the last 50% assigned to the intervention group. Participants were allocated randomly in equal proportions, and the random list was validated by a statistician.
| Arm | Type | Receives |
|---|---|---|
| Nutrition supplement group | Experimental | Dietary Supplement: Compound plant nutrientsThe 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. |
| placebo group | Placebo comparator | Dietary Supplement: placeboThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound plant nutrientsThe 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. | Dietary supplement | Nutrition supplement group |
| placeboThe 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 group |
Primary outcome
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)
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.
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.
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 41932890Zhao 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;17(1):6132. doi: 10.1038/s41467-026-71167-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruihua Dong principal investigator
School of Public Health，Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compound plant nutrients in people with Intestinal Functional Disorder and Inflammation, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal microplastics (MPs) levels as assessed by Py-GC/MS (time frame: up to 2 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06437119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.