Novel Strategies for the Enhancement of the Potency of Nutraceuticals With Low Oral Bioavailability and Their Application in Novel Functional Foods for Optimum Protection of the Aging Brain
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of total curcumin [nmol/L*h]
研究概览
简要总结
Curcumin, a lipophilic polyphenol derived from the plant curcuma longa possesses numerous health-promoting activities. The oral bioavailability of curcumin is low due to its poor aqueous solubility, limited gastrointestinal absorption, rapid metabolism and excretion. Therefore, we tested, in a randomized crossover study, simultaneous application of phytochemicals and micellar solubilisation, alone and together, as strategies to enhance the absorption of curcumin into the body. Furthermore, we investigated age and sex differences in curcumin pharmacokinetics.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers with routine blood chemistry values within the normal ranges
- •Age: 18-35 years or > 60 years
排除标准
- •overweight (BMI >30 kg/m2)
- •metabolic and endocrine diseases
- •pregnancy
- •lactation
- •drug abuse
- •use of dietary supplements or any form of medication (with the exception of oral contraceptives)
- •frequent alcohol consumption (>20 g ethanol/d)
- •adherence to a restrictive dietary regimen
- •physical activity of more than 5 h/wk
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of total curcumin [nmol/L*h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Area under the plasma concentration versus time curve (AUC) of total demethoxycurcumin [nmol/L*h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Area under the plasma concentration versus time curve (AUC) of total bisdemethoxycurcumin [nmol/L*h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Maximum plasma concentration (Cmax) of total curcumin [nmol/L]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time to reach maximum plasma concentration (Tmax) of total curcumin [h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
次要结局
- 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 triacylglycerols [mg/dL](0, 4, 24h post-dose)
- Serum uric acid [mg/dL](0, 4, 24h post-dose)
- Serum alkaline phosphatase activity [U/L](0, 4, 24h post-dose)
- Serum bilirubin [mg/dL](0, 4, 24h post-dose)
- Serum aspartate transaminase activity [U/L](0, 4, 24h post-dose)
- Serum alanine transaminase activity [U/L](0, 4, 24h post-dose)
- Serum gamma-glutamyl transferase activity [U/L](0, 4, 24h post-dose)