Clinical trial NCT01925287: Oral Bioavailability of Curcumin From Micronized Powder and Liquid Micelles in Healthy Young Women and Men
Official title: Novel Strategies for the Enhancement of the Potency of Nutraceuticals With Low Oral Bioavailability and Their Application in Novel Functional Foods for Optimum Protection of the Aging Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pharmacokinetics of Novel Curcumin Formulations
Safety of Novel Curcumin Formulations
Keywords: bioavailability
curcumin
curcuma longa
healthy humans
safety
sex differences
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2013-08-19
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of total curcumin [nmol/L*h]
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
measure: Area under the plasma concentration versus time curve (AUC) of total demethoxycurcumin [nmol/L*h]
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
measure: Area under the plasma concentration versus time curve (AUC) of total bisdemethoxycurcumin [nmol/L*h]
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
measure: Maximum plasma concentration (Cmax) of total curcumin [nmol/L]
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
measure: Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
measure: Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
measure: Time to reach maximum plasma concentration (Tmax) of total curcumin [h]
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
measure: Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
measure: Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
Secondary outcomes:
measure: Serum aspartate transaminase activity [U/L]
timeFrame: Baseline
measure: Serum aspartate transaminase activity [U/L]
timeFrame: 4 h post-dose
measure: Serum aspartate transaminase activity [U/L]
timeFrame: 24 h post-dose
measure: Serum alanine transaminase activity [U/L]
timeFrame: Baseline
measure: Serum alanine transaminase activity [U/L]
timeFrame: 4 h post-dose
measure: Serum alanine transaminase activity [U/L]
timeFrame: 24 h post-dose
measure: Serum gamma-glutamyl transferase activity [U/L]
timeFrame: Baseline
measure: Serum gamma-glutamyl transferase activity [U/L]
timeFrame: 4 h post-dose
measure: Serum gamma-glutamyl transferase activity [U/L]
timeFrame: 24 h post-dose
measure: Serum alkaline phosphatase activity [U/L]
timeFrame: Baseline
measure: Serum alkaline phosphatase activity [U/L]
timeFrame: 4 h post-dose
measure: Serum alkaline phosphatase activity [U/L]
timeFrame: 24 h post-dose
measure: Serum bilirubin [mg/dL]
timeFrame: Baseline
measure: Serum bilirubin [mg/dL]
timeFrame: 4 h post-dose
measure: Serum bilirubin [mg/dL]
timeFrame: 24 h post-dose
measure: Serum uric acid [mg/dL]
timeFrame: Baseline
measure: Serum uric acid [mg/dL]
timeFrame: 4 h post-dose
measure: Serum uric acid [mg/dL]
timeFrame: 24 h post-dose
measure: Serum cystatin C [mg/L]
timeFrame: Baseline
measure: Serum cystatin C [mg/L]
timeFrame: 4 h post-dose
measure: Serum cystatin C [mg/L]
timeFrame: 24 h post-dose
measure: Glomerular filtration rate [mL/min]
timeFrame: Baseline
measure: Glomerular filtration rate [mL/min]
timeFrame: 4 h post-dose
measure: Glomerular filtration rate [mL/min]
timeFrame: 24 h post-dose
measure: Serum creatinine [mg/dL]
timeFrame: Baseline
measure: Serum creatinine [mg/dL]
timeFrame: 4 h post-dose
measure: Serum creatinine [mg/dL]
timeFrame: 24 h post-dose
measure: Serum total cholesterol [mg/dL]
timeFrame: Baseline
measure: Serum total cholesterol [mg/dL]
timeFrame: 4 h post-dose
measure: Serum total cholesterol [mg/dL]
timeFrame: 24 h post-dose
measure: Serum HDL cholesterol [mg/dL]
timeFrame: Baseline
measure: Serum HDL cholesterol [mg/dL]
timeFrame: 4 h post-dose
measure: Serum HDL cholesterol [mg/dL]
timeFrame: 24 h post-dose
measure: Serum LDL cholesterol [mg/dL]
timeFrame: Baseline
measure: Serum LDL cholesterol [mg/dL]
timeFrame: 4 h post-dose
measure: Serum LDL cholesterol [mg/dL]
timeFrame: 24 h post-dose
measure: Serum triacylglycerols [mg/dL]
timeFrame: Baseline
measure: Serum triacylglycerols [mg/dL]
timeFrame: 4 h post-dose
measure: Serum triacylglycerols [mg/dL]
timeFrame: 24 h post-dose
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim
Study officials:
affiliation: University of Hohenheim, Stuttgart, Germany
name: Jan Frank, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schiborr C, Kocher A, Behnam D, Jandasek J, Toelstede S, Frank J. The oral bioavailability of curcumin from micronized powder and liquid micelles is significantly increased in healthy humans and differs between sexes. Mol Nutr Food Res. 2014 Mar;58(3):516-27. doi: 10.1002/mnfr.201300724. Epub 2014 Jan 9.