Effects of BLa80 and LRa05 on the Gut Microbiota Metabolite Profile of Healthy Individuals: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Serum metabolomic profiles measured by HPLC-MS/MS
研究概览
简要总结
Gut microbiota play a key role in polyphenol metabolism, participating in the breakdown of dietary components and producing various small molecule metabolites that affect human health. However, little is currently known about how gut microbes metabolize dietary compounds and produce bioactive metabolites. This study aims to use metabolomics to precisely identify food-derived metabolites in the blood to investigate whether probiotics (BLa80, LRa05) can enhance the breakdown of dietary components and improve their absorption and utilization in the human body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants aged 18 to 60 years;
- •Healthy individuals;
- •Participants must provide written informed consent.
排除标准
- •History of gastrointestinal surgery, other gastrointestinal diseases, metabolic disorders, immunodeficiency, hyperthyroidism, or cardiac or liver disease;
- •Use of immunosuppressants;
- •Pregnant or breastfeeding women;
- •Participants who have taken antibiotics or probiotics within the previous 3 months;
- •Planned surgery during the study period;
- •Patients with neurological disorders or psychiatric illness.
结局指标
主要结局
Serum metabolomic profiles measured by HPLC-MS/MS
时间窗: Baseline (week 0), week 4, and week 8 post intervention
Untargeted serum metabolomic profiling will be performed using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) to assess changes in circulating metabolite concentrations over time.
次要结局
未报告次要终点