Plasmakinetics of Micellar Solubilized Xanthohumol in Metabolically Healthy Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Systemic exposure to Xanthohumol
研究概览
简要总结
The aim of this study is to investigate the rate and extend of the plasma appearance of native Xanthohumol and Xanthohumol integrated into micelles in healthy men and women. Therefore, participants consume capsules with either 86 or 172 mg of native Xanthohumol or Xanthohumol integrated into micelles. In an observation period of 24 hours, Xanthohumol and its major metabolites are analyzed in plasma.
详细描述
In a crossover design, 6 healthy young men and 6 healthy young women participate in 4 Xanthohumol interventions with either 86 or 172 mg native or micellar solubilized Xanthohumol. During an observation period of 24 hours, Xanthohumol and its major metabolites Isoxanthohumol, 8- and 6-Prenylnaringenin are analyzed in plasma. Each intervention will be separated by a wash-out period of 14 days. Typical plasmakinetic analyses (Cmax, tmax, AUC, t1/2, bioavailability) will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI: 18,5 - 24,9 kg/m2
- •metabolically healthy
- •written consent
排除标准
- •low or high blood pressure
- •dyslipidemia
- •insulin resistance or diabetes mellitus type 1 or type 2
- •gastrointestinal diseases (e.g. food intolerances or allergies)
- •liver, kidney and/or thyroid diseases
- •hepatitis B or C, HIV Infection
- •chronic inflammatory diseases
- •disordered eating
- •psychological diseases
- •alcohol and/or drug abuse
- •veganism or unbalanced diets
- •use of medication
- •pregnancy or lactating
- •participation in another intervention study
结局指标
主要结局
Systemic exposure to Xanthohumol
时间窗: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Mean area under the curve (AUC) of plasma concentration vs. time of total Xanthohumol (nmol/L\*h)
Cmax Xanthohumol
时间窗: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Mean maximum plasma concentration of total Xanthohumol (nmol/L)
tmax Xanthohumol
时间窗: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Time to reach maximum plasma concentration of total Xanthohumol \[h\]
Oral bioavailability Xanthohumol
时间窗: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Minimum bioavailable amount of the ingested compound (%)
次要结局
- Systemic exposure to Xanthohumol glucuronides(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose)
- Systemic exposure to Xanthohumol sulfates(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose)
- Systemic exposure to free Xanthohumol(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose)
- Cmax Xanthohumol glucuronides(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose)
- Cmax Xanthohumol sulfates(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose)
- Cmax free Xanthohumol(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose)
- tmax Xanthohumol glucuronides(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose)
- tmax Xanthohumol sulfates(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose)
- tmax free Xanthohumol(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose)
研究者
Prof. Dr. Sarah Egert
Prof. PhD
University of Bonn