Oral Bioavailability of Curcumin From Micronized Powder and Liquid Micelles in Healthy Young Women and Men

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pharmacokinetics of Novel Curcumin Formulations, Safety of Novel Curcumin Formulations

Intervention / Treatment
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* Dietary Supplement: curcumin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Native curcumin powder<br>500 mg curcumin as native powder | Dietary Supplement: curcumin<br>* 500 mg curcumin were given orally either as native powder, micronized powder, or liquid micelles<br>|
| Experimental: Micronized curcumin powder<br>500 mg curcumin as micronized powder | Dietary Supplement: curcumin<br>* 500 mg curcumin were given orally either as native powder, micronized powder, or liquid micelles<br>|
| Experimental: Curcumin micelles<br>500 mg curcumin incorporated into liquid micelles | Dietary Supplement: curcumin<br>* 500 mg curcumin were given orally either as native powder, micronized powder, or liquid micelles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum aspartate transaminase activity [U/L] |  | Baseline | 
| Serum aspartate transaminase activity [U/L] |  | 4 h post-dose | 
| Serum aspartate transaminase activity [U/L] |  | 24 h post-dose | 
| Serum alanine transaminase activity [U/L] |  | Baseline | 
| Serum alanine transaminase activity [U/L] |  | 4 h post-dose | 
| Serum alanine transaminase activity [U/L] |  | 24 h post-dose | 
| Serum gamma-glutamyl transferase activity [U/L] |  | Baseline | 
| Serum gamma-glutamyl transferase activity [U/L] |  | 4 h post-dose | 
| Serum gamma-glutamyl transferase activity [U/L] |  | 24 h post-dose | 
| Serum alkaline phosphatase activity [U/L] |  | Baseline | 
| Serum alkaline phosphatase activity [U/L] |  | 4 h post-dose | 
| Serum alkaline phosphatase activity [U/L] |  | 24 h post-dose | 
| Serum bilirubin [mg/dL] |  | Baseline | 
| Serum bilirubin [mg/dL] |  | 4 h post-dose | 
| Serum bilirubin [mg/dL] |  | 24 h post-dose | 
| Serum uric acid [mg/dL] |  | Baseline | 
| Serum uric acid [mg/dL] |  | 4 h post-dose | 
| Serum uric acid [mg/dL] |  | 24 h post-dose | 
| Serum cystatin C [mg/L] |  | Baseline | 
| Serum cystatin C [mg/L] |  | 4 h post-dose | 
| Serum cystatin C [mg/L] |  | 24 h post-dose | 
| Glomerular filtration rate [mL/min] |  | Baseline | 
| Glomerular filtration rate [mL/min] |  | 4 h post-dose | 
| Glomerular filtration rate [mL/min] |  | 24 h post-dose | 
| Serum creatinine [mg/dL] |  | Baseline | 
| Serum creatinine [mg/dL] |  | 4 h post-dose | 
| Serum creatinine [mg/dL] |  | 24 h post-dose | 
| Serum total cholesterol [mg/dL] |  | Baseline | 
| Serum total cholesterol [mg/dL] |  | 4 h post-dose | 
| Serum total cholesterol [mg/dL] |  | 24 h post-dose | 
| Serum HDL cholesterol [mg/dL] |  | Baseline | 
| Serum HDL cholesterol [mg/dL] |  | 4 h post-dose | 
| Serum HDL cholesterol [mg/dL] |  | 24 h post-dose | 
| Serum LDL cholesterol [mg/dL] |  | Baseline | 
| Serum LDL cholesterol [mg/dL] |  | 4 h post-dose | 
| Serum LDL cholesterol [mg/dL] |  | 24 h post-dose | 
| Serum triacylglycerols [mg/dL] |  | Baseline | 
| Serum triacylglycerols [mg/dL] |  | 4 h post-dose | 
| Serum triacylglycerols [mg/dL] |  | 24 h post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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curcumin, bioavailability, curcuma longa, healthy humans, safety, sex differences