Absorption and Excretion Kinetics of the Bioactive Ingredients of Rice Bran Extract
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Cumulative urinary excretion of total ferulic acid [nmol/g creatinine]
研究概览
简要总结
The oral absorption and urinary excretion kinetics of the bioactive ingredients from rice bran (gamma-oryzanol, tocotrienols, tocopherols and ferulic acid esters) after incorporation into an oat porridge (oat porridge) compared to unprocessed rice bran extract oil were investigated. The influence of the type of preparation (with water vs. milk) of porridge on the bioavailability of the bioactive compounds was compared. The study followed a single dose (2 g rice bran extract), randomized, three armed crossover study design with ≥1-week washout periods. Plasma and urine samples were collected at intervals up to 24 h after intake.
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
- None
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
- •Healthy Volunteers with blood chemistry values within normal ranges
- •Age 18 to 35 years
- •BMI 19 to 25 kg per m2
排除标准
- •Pregnancy or lactation
- •Alcohol and or drug abuse
- •Use of dietary supplements or any medications except contraceptives
- •Any known malignant, metabolic and endocrine diseases
- •Previous cardiac infarction
- •Participation in a clinical trial within the past 1 week prior to recruitment
- •Physical activity of more than 5 h per wk
- •Lactose intolerance
- •Milk intolerance
结局指标
主要结局
Cumulative urinary excretion of total ferulic acid [nmol/g creatinine]
时间窗: 0-24 h post dose
Mean area under the curve (AUC) of plasma concentration vs. time of total ferulic acid [nmol/L*h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total ferulic acid after deconjugation with beta-glucuronidase/sulphatase
Mean area under the curve (AUC) of plasma concentration vs. time of total gamma-oryzanol [nmol/L*h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Mean maximum plasma concentration (Cmax) of total total alfa, beta, gamma and delta tocopherols and tocotrienols [nmol/L]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Time to reach maximum plasma concentration (Tmax) of total ferulic acid [h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total ferulic acid after deconjugation with beta-glucuronidase/sulphatase
Cumulative urinary excretion of total Vitamin E metabolites [nmol/g creatinine]
时间窗: 0-24 h post dose
Mean area under the curve (AUC) of plasma concentration vs. time of total alfa, beta, gamma and delta tocopherols and tocotrienols [nmol/L*h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Mean maximum plasma concentration (Cmax) of total ferulic acid [nmol/L]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total ferulic acid after deconjugation with beta-glucuronidase/sulphatase
Mean maximum plasma concentration (Cmax) of total gamma-oryzanol [nmol/L]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total gamma-oryzanol after deconjugation with beta-glucuronidase/sulphatase
Time to reach maximum plasma concentration (Tmax) of total alfa, beta, gamma and delta tocopherols and tocotrienols [h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Time to reach maximum plasma concentration (Tmax) of total gamma-oryzanol [h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total gamma-oryzanol after deconjugation with beta-glucuronidase/sulphatase
Cumulative urinary excretion of total gamma-oryzanol [nmol/g creatinine]
时间窗: 0-24 h post dose
次要结局
- Serum alanine transaminase activity [U/L](0, 4, 24h post-dose)
- Serum triacylglycerols [mg/dL](0, 4, 24h post-dose)
- Serum aspartate transaminase activity [U/L](0, 4, 24h post-dose)
- Serum bilirubin(0, 4, 24h post-dose)
- LDL/HDL cholesterol ratio(0, 4, 24h post-dose)
- Glomerular filtration rate [mL/min](0, 4, 24h post-dose)
- Serum gamma-glutamyl transferase activity [U/L](0, 4, 24h post-dose)
- Serum uric acid [mg/dL](0, 4, 24h post-dose)
- Serum creatinine [mg/dL](0, 4, 24h post-dose)
- Serum total cholesterol [mg/dL](0, 4, 24h post-dose)
- Serum HDL cholesterol [mg/dL](0, 4, 24h post-dose)
- Serum LDL cholesterol [mg/dL](0, 4, 24h post-dose)
- Serum alkaline phosphatase activity [U/L](0, 4, 24h post-dose)
- Serum glucose [mg/dL](0, 24h post-dose)