Pharmacokinetics and Bioavailability of Three Chrysin Formulations in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cmax: maximum plasma concentration
研究概览
简要总结
This study seeks to evaluate and compare the pharmacokinetics of a micellar chrysin formulation (LipoMicel Chrysin) with that of a non-micellar chrysin formulation as well as a standard/unformulated chrysin supplement. The study also seeks to determine the short-term effects and safety of daily oral supplementation of LipoMicel Chrysin in healthy adult volunteers over a 30-day study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •male or female aged 21-65 years
- •healthy, good physical condition
- •voluntary, written, informed consent to participate in the study.
排除标准
- •use of anti-inflammatory or non-steroidal anti-inflammatory drugs
- •previous history of cardiovascular disease or acute or chronic inflammatory disease
- •use of antioxidant or polyphenol supplements or cholesterol-lowering agents
- •change of diet habits or lifestyle (diet, physical activity, etc.)
- •alcohol or substance abuse history
- •use of nicotine or tobacco
- •participation in another investigational study
研究组 & 干预措施
LipoMicel Chrysin
Each participant receives their treatment i.e., LipoMicel Chrysin at a total dose of 1000 mg chrysin. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition) 2 hours post-dose. Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 7 days between each treatment is used.
干预措施: LipoMicel Chrysin (Dietary Supplement)
Non-micellar Chrysin
Each participant receives their treatment i.e., Non-Micellar Chrysin at a total dose of 1000 mg chrysin. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition) 2 hours post-dose. Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 7 days between each treatment is used.
干预措施: Non-Micellar Chrysin (Dietary Supplement)
Standard Unformulated Chrysin
Each participant receives their treatment i.e., Standard Unformulated Chrysin at a total dose of 1000 mg chrysin. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition) 2 hours post-dose. Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 7 days between each treatment is used.
干预措施: Standard/Unformulated Chrysin (Dietary Supplement)
结局指标
主要结局
Cmax: maximum plasma concentration
时间窗: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)]
To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing chrysin.
AUC: the area under the concentration-time curve
时间窗: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)]
To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing chrysin.
Tmax: the time point of maximum plasma concentration
时间窗: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)]
To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax)
次要结局
- Alanine aminotransferase (ALT)([Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)])
- Aspartate aminotransferase (AST)([Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)])
- Total bilirubin (TB)([Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)])
- Serum creatinine([Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)])
- Glomerular filtration rate (GFR)([Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)])
- Fasting blood glucose([Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)])
- HbA1c([Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)])
- Total cholesterol([Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)])
- Triglycerides([Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)])
- Low-density lipoprotein (LDL) cholesterol([Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)])
- High-density lipoprotein (HDL) cholesterol([Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)])