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

Fudan University

Status: Completed

Conditions: Inflammation; Intestinal Functional Disorder

Treatments: Dietary Supplement: Compound plant nutrients; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06437119

IRB#2024-03-1102

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 2 patient groups, including a placebo group

Nutrition supplement group

Experimental group

Description:

The Composite polyphenols intervention agent includes extracts of licorice, sophora, wild cherry berry, dendrobium officinale, and pomegranate. They should be taken three times a day, one pack at a time, brewed and dissolved in warm water, and taken with meals or after meals.

Treatment:

Dietary Supplement: Compound plant nutrients

placebo group

Placebo Comparator group

Description:

A placebo with an indistinguishable appearance and color. 3 times a day, 1 pack at a time, dissolve in warm water and take with meals or after meals.

Treatment:

Dietary Supplement: placebo