Oral Bioavailability of Curcumin From Micronized Powder and Liquid Micelles in Healthy Young Women and Men
- Conditions
- Pharmacokinetics of Novel Curcumin FormulationsSafety of Novel Curcumin Formulations
- Registration Number
- NCT01925287
- Lead Sponsor
- University of Hohenheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- healthy volunteers with routine blood chemistry values within the normal ranges
- 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)
- smoking
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) of total demethoxycurcumin [nmol/L*h] 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] 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] 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] 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] 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] 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] 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] 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] 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
- Secondary Outcome Measures
Name Time Method 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 Glomerular filtration rate [mL/min] 24 h post-dose Serum creatinine [mg/dL] 24 h post-dose Serum triacylglycerols [mg/dL] 24 h post-dose Serum cystatin C [mg/L] 24 h post-dose Serum HDL cholesterol [mg/dL] 24 h post-dose
Trial Locations
- Locations (1)
University of Hohenheim
🇩🇪Stuttgart, Germany
University of Hohenheim🇩🇪Stuttgart, Germany