A Randomized Double-blind Controlled Trial Study on the Antagonistic Effect of Composite Polyphenols on Health Damage Caused by Environmental Pollutants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Fecal microplastics (MPs) levels as assessed by Py-GC/MS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Participants aged 18-65 years;
- •Body mass index (BMI) < 35 kg/m²;
- •On-campus residence for one year and no need to leave the province during the trial period;
- •Agreeing to and signing the informed consent form.
排除标准
- •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.
研究组 & 干预措施
Nutrition supplement group
The nutrition supplement group received the composite polyphenols intervention agent. The main active components of the composite polyphenols intervention agent include a mixture of 43 types of polyphenols. The composite polyphenols intervention agent is powders encapsulated in sachets, each containing 155 mg composite polyphenols. The dosage was three times daily, with a total intake of 465mg of composite polyphenols. The intervention agent should be taken one sachet each time, dissolved in warm water and taken during or after meals in the morning, afternoon, and evening.
干预措施: Compound plant nutrients (Dietary Supplement)
placebo group
The placebo group received the placebo. The placebo mainly consists of resistant dextrin and erythritol. Apart from the contents, the appearance, color, and consumption method of the placebo are the same as those of the intervention agent. Participants were not informed of their group allocation in any way.
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Fecal microplastics (MPs) levels as assessed by Py-GC/MS
时间窗: up to 2 months
Py-GC/MS method for detecting microplastic (MPs) levels in feces of research subjects. The concentration of fecal microplastics will be reported in units of μ g/g dry weight (μ g/g dw)
Fecal metagenomic sequencing as sequenced using the Illumina NovaSeq/HiSeq Xten platform
时间窗: up to 2 months
DNA was extracted from fecal samples using the FastPure Stool DNA Isolation Kit (Magnetic bead) (MJYH, Shanghai, China). The DNA fragments were amplified via bridge PCR and sequenced using the Illumina NovaSeq/HiSeq Xten platform (Illumina, USA). Raw data were processed using Fastp and BWA software for quality control and removal of host DNA sequences. The abundance of genes in each sample was described using RPKM.
Blood Metabolomics as assessed by UPLC-TripleTOF
时间窗: About 2 months
The pretreated samples were analyzed using an Ultra-high Performance Liquid Chromatography with quadrupole time-of-flight mass spectrometry (UPLC-TripleTOF) system (AB SCIEX). The samples were separated using a BEH C18 chromatography column (100 mm\*2.1 mm i.d., 1.8 µm) and detected via mass spectrometry. The mass spectrometry signal was acquired in positive and negative ion scanning modes, with a mass-to-charge ratio (m/z) range of 50-1000. Raw data were imported into the Progenesis QI software (Waters Corporation, Milford, USA) for processing, generating a data matrix containing retention time, m/z, and peak intensity. The MS and MS/MS spectra were matched with the HMDB (http://www.hmdb.ca/) and Metlin (https://metlin.scripps.edu/) databases to identify metabolites.
Inflammatory cytokines as assesed by Luminex technology
时间窗: About 2 months
The levels of 10 inflammatory cytokines in blood plasma samples were detected using Luminex technology, including IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, and IFN-γ. Inflammatory cytokine indicators are described in pg/ml units.
Blood glucose indicators as assessed by the Hitachi 7180 fully automatic biochemical analyzer
时间窗: About 2 months
Using the Hitachi 7180 fully automatic biochemical analyzer to measure glucose (glycated serum protein, GSP; glucose, GLU) indicators. Blood glucose indicators are described in mmol/l units.
Blood lipid indicators as assessed by the Hitachi 7180 fully automatic biochemical analyzer
时间窗: about 2 months
Using the Hitachi 7180 fully automatic biochemical analyzer to measure lipid (total cholesterol, CHO; triglycerides, TG; high-density lipoprotein cholesterol, HDL; low-density lipoprotein cholesterol, LDL) indicators. Blood lipid indicators are described in mmol/l units.
Routine blood examination as assessed by the Dima DH36X fully automatic blood cell analyzer
时间窗: About 1 months
Using the Dima DH36X fully automatic blood cell analyzer for routine blood examination (three-part differential). We measured the white blood cell count (WBC), lymphocyte count (LYM), monocyte count (MXD), and neutrophil count (NEU) in the blood routine and reported them in units of 10 \* 9 cells/L
次要结局
未报告次要终点
研究者
Ruihua Dong
Associate Professor
Fudan University