Probiotics in Alleviating Microplastic-Induced Obesity

Fudan University

Status: Completed

Conditions: Inflammation; Intestinal Functional Disorder

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotics (Lactiplantibacillus plantarum PD01)

Study type: Interventional

Funder types: Other

Identifiers

NCT07416214

H2025029

Details and patient eligibility

About

The study attempts to conduct randomized double-blind controlled trials to understand whether daily exposure to microplastics (MPs) can cause potential impacts on human health, explore whether the intake of Lactiplantibacillus plantarum PD01 can alleviate potential obesity-related damages caused by MPs, and provide a scientific basis for the prevention and nutritional intervention of health hazards caused by MP exposure.

Enrollment: 96 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18-65 years.
• Body Mass Index (BMI) ≥ 24.0 kg/m² or meeting the criteria for central obesity (waist circumference ≥ 90 cm for men, ≥ 85 cm for women); participants with mild abnormalities in blood lipids and liver function indicators will be prioritized.
• Permanent residents of the local area during the trial period, with no plans for long-term business trips or travel.
• Fully understand the research content and voluntarily sign the informed consent form.

Exclusion criteria

• Diagnosed congenital or acquired immunodeficiency diseases, severe allergic diseases, active gastrointestinal diseases, and other acute or chronic diseases requiring long-term treatment.
• Use of antibiotics, immunosuppressants, probiotics, prebiotics, synbiotics, or other drugs that clearly affect gut microbiota or gastrointestinal function within the 6 months prior to the trial.
• Regular intake of nutritional supplements (such as vitamins, fish oil, etc.) within the 6 months prior to the trial.
• Having bad lifestyle habits such as smoking or alcoholism.
• Women who are pregnant, lactating, or planning to become pregnant.
• Weight change exceeding 5% of body weight within the 3 months prior to the trial.
• Participation in or planning to participate in any other clinical intervention studies.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups, including a placebo group

Probiotic intervention group

Experimental group

Description:

The Probiotic intervention agent includes 0.2g Lactiplantibacillus plantarum FABYIO PD01 (containing 10 billion CFU) and 1.8g Fructooligosaccharides. They should be taken three times a day, one pack at a time, brewed and dissolved in warm water (below 40°C), and taken with meals or after meals.

Treatment:

Dietary Supplement: Probiotics (Lactiplantibacillus plantarum PD01)

Placebo control group

Placebo Comparator group

Description:

The Placebo control agent includes 2g Fructooligosaccharides. They should be taken three times a day, one pack at a time, brewed and dissolved in warm water (below 40°C), and taken with meals or after meals.

Treatment:

Dietary Supplement: Placebo