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
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of total demethoxycurcumin [nmol/L*h]
研究概览
简要总结
Background: The oral bioavailability of curcumin is low due to its limited intestinal uptake, rapid metabolism and excretion from the body. Considering its potent reported health-beneficial properties, researchers have tried to increase its bioavailability as a means to enhance its biological activities.
Objective: The aim of the project was to develop novel curcumin formulations with enhanced oral bioavailability and to study the safety of the formulations and potential sex-differences in humans.
Design: In this single-blind crossover study with three arms separated by ≥1-week washout periods, healthy subjects (13 women, 10 men) were provided standardized meals and took, in random order, a single oral dose of 500 mg curcumin as native powder, micronized powder, or liquid micelles. Blood and urine samples were collected in intervals for 24 h and total curcumin, demethoxycurcumin, and bis-demethoxycurcumin were quantified.
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 routine blood chemistry values within the normal ranges
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
- •participation in a clinical trial within the past 3 months prior to recruitment
- •known intolerance against curcuma
研究组 & 干预措施
Curcumin micelles
500 mg curcumin incorporated into liquid micelles
干预措施: curcumin (Dietary Supplement)
Micronized curcumin powder
500 mg curcumin as micronized powder
干预措施: curcumin (Dietary Supplement)
Native curcumin powder
500 mg curcumin as native powder
干预措施: curcumin (Dietary Supplement)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of total demethoxycurcumin [nmol/L*h]
时间窗: 0, 0.5, 1, 1.5, 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, 1.5, 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 demethoxycurcumin [nmol/L]
时间窗: 0, 0.5, 1, 1.5, 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, 1.5, 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, 1.5, 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 curcumin [nmol/L*h]
时间窗: 0, 0.5, 1, 1.5, 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 curcumin [nmol/L]
时间窗: 0, 0.5, 1, 1.5, 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, 1.5, 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, 1.5, 2, 4, 6, 8 and 24 h post-dose
Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
次要结局
- Glomerular filtration rate [mL/min](24 h post-dose)
- Serum triacylglycerols [mg/dL](24 h post-dose)
- Serum creatinine [mg/dL](24 h post-dose)
- Serum aspartate transaminase activity [U/L](24 h post-dose)
- Serum total cholesterol [mg/dL](24 h post-dose)
- Serum LDL cholesterol [mg/dL](24 h post-dose)
- Serum alanine transaminase activity [U/L](24 h post-dose)
- Serum gamma-glutamyl transferase activity [U/L](24 h post-dose)
- Serum bilirubin [mg/dL](24 h post-dose)
- Serum uric acid [mg/dL](24 h post-dose)
- Serum alkaline phosphatase activity [U/L](24 h post-dose)
- Serum cystatin C [mg/L](24 h post-dose)
- Serum HDL cholesterol [mg/dL](24 h post-dose)
- Serum aspartate transaminase activity [U/L](Baseline)
- Serum aspartate transaminase activity [U/L](4 h post-dose)
- Serum alanine transaminase activity [U/L](Baseline)
- Serum alanine transaminase activity [U/L](4 h post-dose)
- Serum gamma-glutamyl transferase activity [U/L](Baseline)
- Serum gamma-glutamyl transferase activity [U/L](4 h post-dose)
- Serum alkaline phosphatase activity [U/L](Baseline)
- Serum alkaline phosphatase activity [U/L](4 h post-dose)
- Serum bilirubin [mg/dL](Baseline)
- Serum bilirubin [mg/dL](4 h post-dose)
- Serum uric acid [mg/dL](Baseline)
- Serum uric acid [mg/dL](4 h post-dose)
- Serum cystatin C [mg/L](Baseline)
- Serum cystatin C [mg/L](4 h post-dose)
- Glomerular filtration rate [mL/min](Baseline)
- Glomerular filtration rate [mL/min](4 h post-dose)
- Serum creatinine [mg/dL](Baseline)
- Serum creatinine [mg/dL](4 h post-dose)
- Serum total cholesterol [mg/dL](Baseline)
- Serum total cholesterol [mg/dL](4 h post-dose)
- Serum HDL cholesterol [mg/dL](Baseline)
- Serum HDL cholesterol [mg/dL](4 h post-dose)
- Serum LDL cholesterol [mg/dL](Baseline)
- Serum LDL cholesterol [mg/dL](4 h post-dose)
- Serum triacylglycerols [mg/dL](Baseline)
- Serum triacylglycerols [mg/dL](4 h post-dose)