A Human Clinical Trial on the Pharmacokinetics and Safety of Oral Micellar Green Tea Extract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- AUC: the area under the concentration-time curve
研究概览
简要总结
This study seeks to determine the short-term effects of daily oral supplementation of LipoMicel Green Tea on oral absorption and safety of green tea in healthy volunteers.
The primary objective is to evaluate and compare the pharmacokinetics of LipoMicel Green Tea (LGT) with that of a standard green tea extract formulation as well as a phytosomal green tea formulation. The secondary objective is to evaluate the safety of LGT in healthy human participants 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 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
Standard Green Tea
Each participant receives their treatment i.e., Standard Green Tea hard gel capsules at a total dose of 300 mg green tea extract. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 48 hours post-dose. A washout period of at least 7 days between each treatment is used.
干预措施: Standard Green Tea (Dietary Supplement)
Phytosome Green Tea
Each participant receives their treatment i.e., Phytosome green tea hard gel capsules at a total dose of 250 mg green tea extract. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 48 hours post-dose. A washout period of at least 7 days between each treatment is used.
干预措施: Phytosome Green Tea (Dietary Supplement)
LipoMicel Green Tea
Each participant receives their treatment i.e., LipoMicel green tea soft gel capsules at a total dose of 300 mg green tea extract. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 48 hours post-dose. A washout period of at least 7 days between each treatment is used.
干预措施: LipoMicel Green Tea (Dietary Supplement)
结局指标
主要结局
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, 48 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested green tea extract in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing green tea extract.
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, 48 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested green tea extract in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing green tea extract.
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, 48 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested green tea extract in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) with that of other capsules containing green tea extract.
次要结局
- Alanine aminotransferase (ALT)(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Aspartate aminotransferase (AST)(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Total bilirubin (TB)(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Serum creatinine(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Glomerular filtration rate (GFR)(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Fasting blood glucose(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Total cholesterol(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Triglycerides(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Low-density lipoprotein (LDL) cholesterol(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- High-density lipoprotein (HDL) cholesterol(0 (baseline; pre-dose), week 2 and week 4 (post-dose))