Pharmacokinetics of Novel Curcumin Formulations, Safety of Novel Curcumin Formulations
Conditions
Keywords
bioavailability, curcumin, curcuma longa, healthy humans, safety, sex differences
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.
Interventions
DIETARY_SUPPLEMENTcurcumin
500 mg curcumin were given orally either as native powder, micronized powder, or liquid micelles
Sponsors
German Federal Ministry of Education and Research
University of Hohenheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy volunteers with routine blood chemistry values within the normal ranges
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 |
| 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
| Measure | Time frame |
|---|---|
| Serum total cholesterol [mg/dL] | Baseline |
| Serum HDL cholesterol [mg/dL] | Baseline |
| Serum aspartate transaminase activity [U/L] | Baseline |
| Serum triacylglycerols [mg/dL] | Baseline |
| Serum LDL cholesterol [mg/dL] | Baseline |
| Serum alanine transaminase activity [U/L] | Baseline |
| Serum gamma-glutamyl transferase activity [U/L] | Baseline |
| Serum alkaline phosphatase activity [U/L] | Baseline |
| Serum bilirubin [mg/dL] | Baseline |
| Serum uric acid [mg/dL] | Baseline |
| Serum cystatin C [mg/L] | Baseline |
| Glomerular filtration rate [mL/min] | Baseline |
| Serum creatinine [mg/dL] | Baseline |
Countries
Germany
Outcome results
None listed