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
- Interventions
- Dietary Supplement: curcumin
- 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
- Arm && Interventions
Group Intervention Description Curcumin micelles curcumin 500 mg curcumin incorporated into liquid micelles Native curcumin powder curcumin 500 mg curcumin as native powder Micronized curcumin powder curcumin 500 mg curcumin as micronized powder
- 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 alanine transaminase activity [U/L] 24 h post-dose Serum gamma-glutamyl transferase activity [U/L] 24 h post-dose Serum cystatin C [mg/L] 24 h post-dose Serum total cholesterol [mg/dL] 24 h post-dose Serum LDL cholesterol [mg/dL] 24 h post-dose Serum aspartate transaminase 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 HDL cholesterol [mg/dL] 24 h post-dose
Trial Locations
- Locations (1)
University of Hohenheim
🇩🇪Stuttgart, Germany