Metabolic Differences Between Dihydroberberine and Micellar Berberine in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- AUC: the area under the concentration-time curve
研究概览
简要总结
Differences in metabolites of dihydroberberine (DHB) and micellar berberine (LipoMicel®, LMB) are investigated through a randomized study involving human volunteers. Over a 24-hour period, blood samples are collected and subjected to Ultra High-Performance Liquid Chromatography-High Resolution Mass Spectrometry (UHPLC-HRMS) analysis to quantify the concentrations of berberine and its metabolites.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21 or older
- •healthy, good physical condition
排除标准
- •Pregnancy or breast-feeding
- •Gastrointestinal conditions
- •Acute or chronic liver disease
- •Acute or chronic kidney disease
- •Acute or chronic cardiovascular disease
- •Hematological disease
- •Allergy or Intolerance to gluten
- •Allergy or Intolerance to Berberine
- •Use of any form of nicotine or tobacco
- •Alcohol and substance abuse history
- •Use of medications (e.g., blood sugar-lowering agents, or statins)
- •Use of Berberine supplements
- •Participation in another investigational study
结局指标
主要结局
AUC: the area under the concentration-time curve
时间窗: at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.
For each berberine metabolite, PK parameters such as Area Under Curve (AUC) of the blood concentrations over a 24-hour period are reported.
Tmax: the time at which Cmax is reached
时间窗: at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.
For each berberine metabolite, PK parameters such as Tmax, the time at which Cmax is reached, are reported.
Cmax: the maximum blood concentration
时间窗: at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.
For each berberine metabolite, PK parameters such as the maximum blood concentration (Cmax) are reported.
次要结局
未报告次要终点