Improved Oral Bioavailability of Curcumin Incorporated Into Micelles
- Conditions
- Pharmacokinetics of New Curcumin FormulationsSafety of New Curcumin Formulations
- Interventions
- Dietary Supplement: curcumin
- Registration Number
- NCT01982734
- Lead Sponsor
- University of Hohenheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- healthy volunteers with routine blood chemistry values within the normal ranges
- Age: 18-35 years or > 60 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Native curcumin plus phytochemicals curcumin 80 mg curcumin as native powder plus 80 mg sesamin, 40 mg naringenin, 40 mg ferulic acid and 40 mg xanthohumol Native curcumin curcumin 80 mg curcumin as native powder Curcumin micelles curcumin 80 mg curcumin incorporated into liquid micelles Curcumin micelles plus phytochemicals curcumin 80 mg curcumin incorporated into liquid micelles plus 80 mg sesamin, 40 mg naringenin, 40 mg ferulic acid, 40 mg xanthohumol incorporated into micelles
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) of total curcumin [nmol/L*h] 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] 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] 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] 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] 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] 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] 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] 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] 0, 0.5, 1, 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] 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 Serum alkaline phosphatase activity [U/L] 0, 4, 24h post-dose Serum bilirubin [mg/dL] 0, 4, 24h post-dose Serum uric acid [mg/dL] 0, 4, 24h post-dose 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
Trial Locations
- Locations (1)
University of Hohenheim
🇩🇪Stuttgart, Baden-Württemberg, Germany