Evaluating the Safety and Tolerability of LipoMicel Berberine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Safety of LipoMicel Berberine - ALT
研究概览
简要总结
This study aims to evaluate important safety markers related to liver- and kidney function in healthy individuals after treatment with a new formulation, LipoMicel Berberine. The main question this research aims to answer is:
Is the new formulation of Berberine (LipoMicel) with improved bioavailability safe and well tolerated in healthy individuals?
Participants will:
- Take 1000 mg (2 capsules/d) of LipoMicel Berberine orally for a maximum period of 30 days.
- Return to study site weekly for blood tests.
- Keep a diary of their symptoms (collection of adverse events).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men or women between 21-65 years of age.
- •Completed an online health questionnaire on their medical history
- •A voluntarily signed informed consent form.
排除标准
- •Use of anti-inflammatory or non-steroidal anti-inflammatory medication
- •Presence of cardiovascular disease and/or other acute or chronic diseases (e.g., liver, kidney or gastrointestinal diseases).
- •Use of cannabis, nicotine or tobacco
- •Drinking of excess alcohol (>20 g/day)
- •Those who are or plan to become pregnant
- •Use of antioxidant supplements
- •Use of cholesterol-lowering agents
- •Participation in another investigational study
结局指标
主要结局
Safety of LipoMicel Berberine - ALT
时间窗: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in liver function based on ALT.
Safety of Lipomicel Berberine - AST
时间窗: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in liver function based on AST.
Safety of LipoMicel Berberine - Bilirubin
时间窗: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in liver function based on bilirubin.
Safety of LipoMicel Berberine - Serum creatinine
时间窗: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in kidney function based on serum creatinine.
Safety of LipoMicel Berberine - Glomerular filtration rate (GFR)
时间窗: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in kidney function based on GFR.
Safety of LipoMicel Berberine - Fasting blood glucose
时间窗: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in blood glucose levels based on fasting blood glucose.
Safety of LipoMicel Berberine - Total cholesterol (TC)
时间窗: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in lipid profile based on TC.
Safety of LipoMicel Berberine - Low-density lipoprotein (LDL) cholesterol
时间窗: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in lipid profile based on LDL.
Safety of LipoMicel Berberine - High-density lipoprotein (HDL) cholesterol
时间窗: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in lipid profile based on HDL.
Safety of LipoMicel Berberine - Triglycerides (TG)
时间窗: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in lipid profile based on TG.
次要结局
- Tolerability of Treatment: Bloating(From enrollment to the end of treatment at 30 days)
- Tolerability of Treatment: Constipation(From enrollment to the end of treatment at 30 days)
- Tolerability of Treatment: Diarrhea(From enrollment to the end of treatment at 30 days)
- Tolerability of Treatment: Heartburn(From enrollment to the end of treatment at 30 days)
- Tolerability of Treatment: cramps(From enrollment to the end of treatment at 30 days)
- Tolerability of Treatment: knotted feeling in abdomen(From enrollment to the end of treatment at 30 days)
- Tolerability of Treatment: Rash(From enrollment to the end of treatment at 30 days)
- Tolerability of Treatment: Nausea(From enrollment to the end of treatment at 30 days)
- Tolerability of Treatment: Dizziness(From enrollment to the end of treatment at 30 days)
- Tolerability of Treatment: Blurred vision(From enrollment to the end of treatment at 30 days)
- Tolerability of Treatment: Other (unrelated to treatment)(From enrollment to the end of treatment at 30 days)