Study of the Oral Bioavailability of Trans-epsilon-viniferin and Trans-resveratrol From Native and Micellar Solubilized vineatrol30 Vine 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
- Time to reach maximum plasma concentration (Tmax) of total trans-resveratrol [h]
研究概览
简要总结
To enhance the oral bioavailability of the antioxidants trans-resveratrol and trans-ε-viniferin from Vineatrol30 grapevine-shoot extract, the native powder was incorporated into micelles. A single dose, single blind, two arms crossover trial was conducted. Plasma and urine samples were collected at intervals up to 24 h after oral intake of native or micellar Vineatrol30 (500 mg), and resveratrol content was quantified and compared between formulations. Tolerability of the dose was also controlled by safety parameters in plasma.
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
- •Healthy Volunteers with blood chemistry values within normal ranges
- •Age: 18-35 years
- •BMI: 19-25 kg/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 6 weeks prior to recruitment
- •Physical activity of more than 5 h/wk
结局指标
主要结局
Time to reach maximum plasma concentration (Tmax) of total trans-resveratrol [h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Cumulative urinary excretion of total trans-epsilon-viniferin [nmol/g creatinine]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Mean maximum plasma concentration (Cmax) of total trans-epsilon-viniferin [nmol/L]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Time to reach maximum plasma concentration (Tmax) of total trans-epsilon-viniferin [h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Cumulative urinary excretion of total trans-resveratrol [nmol/g creatinine]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Mean maximum plasma concentration (Cmax) of total trans-resveratrol [nmol/L]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Mean area under the curve (AUC) of plasma concentration vs. time of total trans-resveratrol [nmol/L*h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Mean area under the curve (AUC) of plasma concentration vs. time of total trans-epsilon-viniferin [nmol/L*h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
次要结局
- Serum cystatin C [mg/mL](0, 4, 24h post-dose)
- Serum aspartate transaminase activity [U/L](0, 4, 24h post-dose)
- Serum gamma-glutamyl transferase activity [U/L](0, 4, 24h post-dose)
- Serum alkaline phosphatase activity [U/L](0, 4, 24h post-dose)
- LDL/HDL cholesterol ratio(0, 4, 24h post-dose)
- Serum total cholesterol [mg/dL](0, 4, 24h post-dose)
- Glomerular filtration rate [mL/min](0, 4, 24h post-dose)
- Serum glucose [mg/dL](0, 24h post-dose)
- Serum alanine transaminase activity [U/L](0, 4, 24h post-dose)
- Serum creatinine [mg/dL](0, 4, 24h post-dose)
- Serum triacylglycerols [mg/dL](0, 4, 24h post-dose)
- Serum bilirubin(0, 4, 24h post-dose)
- Serum uric acid [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)