CompletedNot Applicable

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

China98 participantsStarted 2024-04-23

Plain-language 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 prevention and treatment of health hazards caused by environmental pollutant exposure.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

.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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: up to 2 months

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

Timeframe: up to 2 months

Blood Metabolomics as assessed by UPLC-TripleTOF

Timeframe: About 2 months

Inflammatory cytokines as assesed by Luminex technology

Timeframe: About 2 months

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

Timeframe: About 2 months

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

Timeframe: about 2 months

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

Timeframe: About 1 months

Trial details

NCT IDNCT06437119

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-01

View on ClinicalTrials.gov More Intestinal Functional Disorder trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

.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.

What they're measuring

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

Timeframe: up to 2 months

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

Timeframe: up to 2 months

Blood Metabolomics as assessed by UPLC-TripleTOF

Timeframe: About 2 months

Inflammatory cytokines as assesed by Luminex technology

Timeframe: About 2 months

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

Timeframe: About 2 months

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

Timeframe: about 2 months

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

Timeframe: About 1 months