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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
96
The probiotic supplement includes 0.2g Lactiplantibacillus plantarum FABYIO PD01 (containing 10 billion CFU) and 1.8g Fructooligosaccharides.
The placebo includes 2.0g Fructooligosaccharides with an indistinguishable appearance and texture.
School of Public Health, Fudan University
Shanghai, Xuhui, China
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 analysis includes 11 types of plastics: PC, PE, PP, PS, PA6, PET, PLA, PVC, PA66, PBAT, and PMMA. The concentration of fecal microplastics will be reported in units of μg/g dry weight.
Time frame: Up to 2 months
Gut microbiota composition as assessed by Fecal Metagenomics
Fecal DNA is extracted and subjected to high-throughput sequencing to analyze the diversity, abundance, and functional genes of the gut microbiota. The analysis aims to observe changes in the microbial community structure following the intervention.
Time frame: Up to 2 months
Blood metabolic profiles as assessed by Blood Metabolomics
Untargeted metabolomics analysis is performed on blood samples to identify alterations in metabolic pathways and metabolite profiles associated with the intervention. Data will be processed to match metabolites with standard databases.
Time frame: Up to 2 months
Inflammatory cytokines and immune markers
Serum levels of inflammatory and immune markers are detected, including Monocyte Chemoattractant Protein-1 (MCP-1), Interleukin-1β (IL-1β), Interleukin-6 (IL-6), Tumor Necrosis Factor-α (TNF-α), P-selectin, C-reactive protein (CRP), and Fibrinogen.
Time frame: Up to 2 months
Blood biochemical indicators as assessed by the Mindray BS200 automatic biochemical analyzer
Serum samples are processed using a Thermo Scientific Sorvall ST 40 centrifuge (3000 rpm, 4°C, 5 min). The supernatant is collected and analyzed using the Mindray BS200 automatic biochemical analyzer. Parameters include liver function indicators and blood lipid indicators (Total Cholesterol, Triglycerides, HDL, LDL, etc.).
Time frame: Up to 2 months
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Routine blood examination (Five-part differential)
Routine blood examination is performed to assess the white blood cell count (WBC) and a five-part differential count (neutrophils, lymphocytes, monocytes, eosinophils, and basophils). Results are reported in standard clinical units.
Time frame: Up to 2 months
Anthropometric and body composition indicators
To comply with reporting standards, these assessments are separated by unit: Weight: Measured in kilograms (kg). Height: Measured in centimeters (cm). BMI: Calculated as weight divided by height squared (kg/m\^2). Circumferences: Waist and hip measurements reported in centimeters (cm). BIA Results: Body fat and muscle mass reported as a percentage of total body composition (%).
Time frame: Up to 2 months