Inflammation, Intestinal Functional Disorder
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProbiotics (Lactiplantibacillus plantarum PD01)
The probiotic supplement includes 0.2g Lactiplantibacillus plantarum FABYIO PD01 (containing 10 billion CFU) and 1.8g Fructooligosaccharides.
DIETARY_SUPPLEMENTPlacebo
The placebo includes 2.0g Fructooligosaccharides with an indistinguishable appearance and texture.
Sponsors
Fudan University
Xiamen Yueyi Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
The on-site implementation personnel and those responsible for coordinating the study only received the study number of the subjects, and were unaware of the intervention group allocation of the subjects. The subjects were also unaware of their intervention allocation. A copy of the sealed envelope of the non blinded study number for each subject is provided only to the study supervisor. Before the completion of data collection, the investigators and researchers kept the blind method for treatment allocation. All subjects were monitored in a double-blind way throughout the study period, and the subjects could not distinguish their own grouping by asking questions or from appearance and texture.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal microplastics (MPs) levels as assessed by Py-GC/MS | Up to 2 months | 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. |
| Measurement of Urinary PAE Metabolites Using UHPLC-MS/MS | 1 Week | Urine samples were stored at -80 ℃ until analysis of urinary creatinine and PAEs concentrations. The urinary PAE metabolites were chromatographically separated on an Agilent Eclipse Plus C18 RRHD column (2.1 × 100 mm, 1.8 μm), and quantified using an SCIEX ExionLC AD ultra-high-performance liquid chromatography system coupled with an AB SCIEX 7500+ triple quadrupole mass spectrometer. |
| Gut microbiota composition as assessed by Fecal Metagenomics | Up to 2 months | 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. |
| Blood metabolic profiles as assessed by Blood Metabolomics | Up to 2 months | 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. |
| Inflammatory cytokines and immune markers | Up to 2 months | 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. |
| Blood biochemical indicators as assessed by the Mindray BS200 automatic biochemical analyzer | Up to 2 months | 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.). |
| Routine blood examination (Five-part differential) | Up to 2 months | 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. |
| Body composition measured by using InBody770 | Up to 2 months | Body composition was analyzed using multi-frequency bioelectrical impedance analysis with the InBody770 body composition analyzer. The measurements included body fat percentage, skeletal muscle mass, and visceral fat area. All measurements were taken while the participants were fasting and after emptying their bladders. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORRuihua Dong
School of Public Health，Fudan University
Outcome results
None listed