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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
23
500 mg curcumin were given orally either as native powder, micronized powder, or liquid micelles
University of Hohenheim
Stuttgart, Germany
Area under the plasma concentration versus time curve (AUC) of total curcumin [nmol/L*h]
Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
Area under the plasma concentration versus time curve (AUC) of total demethoxycurcumin [nmol/L*h]
Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
Area under the plasma concentration versus time curve (AUC) of total bisdemethoxycurcumin [nmol/L*h]
Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
Maximum plasma concentration (Cmax) of total curcumin [nmol/L]
Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]
Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]
Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
Time to reach maximum plasma concentration (Tmax) of total curcumin [h]
Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]
Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]
Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
Serum aspartate transaminase activity [U/L]
Time frame: Baseline
Serum aspartate transaminase activity [U/L]
Time frame: 4 h post-dose
Serum aspartate transaminase activity [U/L]
Time frame: 24 h post-dose
Serum alanine transaminase activity [U/L]
Time frame: Baseline
Serum alanine transaminase activity [U/L]
Time frame: 4 h post-dose
Serum alanine transaminase activity [U/L]
Time frame: 24 h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Time frame: Baseline
Serum gamma-glutamyl transferase activity [U/L]
Time frame: 4 h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Time frame: 24 h post-dose
Serum alkaline phosphatase activity [U/L]
Time frame: Baseline
Serum alkaline phosphatase activity [U/L]
Time frame: 4 h post-dose
Serum alkaline phosphatase activity [U/L]
Time frame: 24 h post-dose
Serum bilirubin [mg/dL]
Time frame: Baseline
Serum bilirubin [mg/dL]
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Time frame: 4 h post-dose
Serum bilirubin [mg/dL]
Time frame: 24 h post-dose
Serum uric acid [mg/dL]
Time frame: Baseline
Serum uric acid [mg/dL]
Time frame: 4 h post-dose
Serum uric acid [mg/dL]
Time frame: 24 h post-dose
Serum cystatin C [mg/L]
Time frame: Baseline
Serum cystatin C [mg/L]
Time frame: 4 h post-dose
Serum cystatin C [mg/L]
Time frame: 24 h post-dose
Glomerular filtration rate [mL/min]
Time frame: Baseline
Glomerular filtration rate [mL/min]
Time frame: 4 h post-dose
Glomerular filtration rate [mL/min]
Time frame: 24 h post-dose
Serum creatinine [mg/dL]
Time frame: Baseline
Serum creatinine [mg/dL]
Time frame: 4 h post-dose
Serum creatinine [mg/dL]
Time frame: 24 h post-dose
Serum total cholesterol [mg/dL]
Time frame: Baseline
Serum total cholesterol [mg/dL]
Time frame: 4 h post-dose
Serum total cholesterol [mg/dL]
Time frame: 24 h post-dose
Serum HDL cholesterol [mg/dL]
Time frame: Baseline
Serum HDL cholesterol [mg/dL]
Time frame: 4 h post-dose
Serum HDL cholesterol [mg/dL]
Time frame: 24 h post-dose
Serum LDL cholesterol [mg/dL]
Time frame: Baseline
Serum LDL cholesterol [mg/dL]
Time frame: 4 h post-dose
Serum LDL cholesterol [mg/dL]
Time frame: 24 h post-dose
Serum triacylglycerols [mg/dL]
Time frame: Baseline
Serum triacylglycerols [mg/dL]
Time frame: 4 h post-dose
Serum triacylglycerols [mg/dL]
Time frame: 24 h post-dose