Comparison of Curcumin Bioavailability

Study Overview
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Brief Summary
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The curcuminoids curcumin, demethoxycurcumin and bisdemethoxycurcumin can be found in the rhizome of turmeric (Curcuma longa). Curcumin is widespread used for colouring foods. Based on its natural low bioavailability and the number of its effects on human health, several approaches such as increasing its water solubility or inhibiting its metabolism were taken to improve its bioavailability. Pharmacokinetics of curcumin from various supplements using those different mechanisms have been compared to the one of native curcumin. The investigator's study here will compare the bioavailability of curcumin from eight different curcumin formulations with native curcumin and between themselves. The study will folllow a single dose (in form of curcumin formulations, normalized to 207 mg curcumin), placebo-controlled, randomized, double-blind, nine-armed crossover study design with ≥ 1-week washout periods. Plasma samples will be collected at intervals up to 24 hours after intake. Investigators will compare the pharmacokinetics between the different curcumin formulations and to native curcumin.

Official Title
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Comparison of the Bioavailability of Different Curcumin Formulations in Healthy Humans

Conditions
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Safety After Oral Intake, Pharmacokinetics After Oral Intake

Intervention / Treatment
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* Dietary Supplement: Native turmeric extract
* Dietary Supplement: Native turmeric extract with 7-9% volatile turmeric oils
* Dietary Supplement: Turmeric extract plus mixture of phytochemicals
* Dietary Supplement: Cyclodextrin complex of curcuminoids
* Dietary Supplement: Turmeric oleoresin
* Dietary Supplement: Liposomal curcumin
* Dietary Supplement: Phytosomal curcumin
* Dietary Supplement: Micellar turmeric extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Volunteers with blood chemistry values within normal ranges Body mass index in a normal range Exclusion Criteria: Pregnancy or lactation Alcohol and or drug abuse Use of dietary supplements or any medications except contraceptives Any known malignant, metabolic and endocrine diseases Previous cardiac infarction Dementia Blood pressure >140/90 mmHg Resting heart rate not within 50 to 90 beats per minute Participation in a clinical trial within the past 6 weeks Smoking Physical activity of more than 5 h per wk

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Native turmeric extract<br>6 capsules of native curcumin (207 mg curcumin) | Dietary Supplement: Native turmeric extract<br>* 207 mg curcumin<br>|
| Experimental: Native turmeric extract with 7-9% volatile turmeric oils<br>6 capsules of the formulation; dosage normalized to 207 mg curcumin | Dietary Supplement: Native turmeric extract with 7-9% volatile turmeric oils<br>* 207 mg curcumin<br>|
| Experimental: Turmeric extract plus mixture of phytochemicals<br>6 capsules of the formulation; dosage normalized to 207 mg curcumin | Dietary Supplement: Turmeric extract plus mixture of phytochemicals<br>* 207 mg curcumin<br>|
| Experimental: Cyclodextrin complex of curcuminoids<br>6 capsules of the formulation; dosage normalized to 207 mg curcumin | Dietary Supplement: Cyclodextrin complex of curcuminoids<br>* 207 mg curcumin<br>|
| Experimental: Turmeric oleoresin<br>6 capsules of the formulation; dosage normalized to 207 mg curcumin | Dietary Supplement: Turmeric oleoresin<br>* 207 mg curcumin<br>|
| Experimental: Liposomal curcumin<br>6 capsules of the formulation; dosage normalized to 207 mg curcumin | Dietary Supplement: Liposomal curcumin<br>* 207 mg curcumin<br>|
| Experimental: Phytosomal curcumin<br>6 capsules of the formulation; dosage normalized to 207 mg curcumin | Dietary Supplement: Phytosomal curcumin<br>* 207 mg curcumin<br>|
| Experimental: Micellar turmeric extract<br>6 capsules of the formulation; dosage normalized to 207 mg curcumin | Dietary Supplement: Micellar turmeric extract<br>* 207 mg curcumin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean area under the curve (AUC) of plasma concentration vs. time of total curcumin [nmol/L*h] | Total curcumin after deconjugation with β-glucuronidase | 0, 1, 2, 4, 6, 8 and 24 hours post dose | 
| Mean area under the curve (AUC) of plasma concentration vs. time of total demethoxycurcumin [nmol/L*h] | Total demethoxycurcumin after deconjugation with β-glucuronidase | 0, 1, 2, 4, 6, 8 and 24 hours post dose | 
| Mean area under the curve (AUC) of plasma concentration vs. time of total bisdemethoxycurcumin [nmol/L*h] | Total bisdemethoxycurcumin after deconjugation with β-glucuronidase | 0, 1, 2, 4, 6, 8 and 24 hours post dose | 
| Maximum plasma concentration (Cmax) of total curcumin [nmol/L] | Total curcumin after deconjugation with β-glucuronidase | 0, 1, 2, 4, 6, 8 and 24 hours post dose | 
| Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L] | Total demethoxycurcumin after deconjugation with β-glucuronidase | 0, 1, 2, 4, 6, 8 and 24 hours post dose | 
| Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L] | Total bisdemethoxycurcumin after deconjugation with β-glucuronidase | 0, 1, 2, 4, 6, 8 and 24 hours post dose | 
| Time to reach maximum plasma concentration (Tmax) of total curcumin [h] | Total curcumin after deconjugation with β-glucuronidase | 0, 1, 2, 4, 6, 8 and 24 hours post dose | 
| Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h] | Total demethoxycurcumin after deconjugation with β-glucuronidase | 0, 1, 2, 4, 6, 8 and 24 hours post dose | 
| Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h] | Total bisdemethoxycurcumin after deconjugation with β-glucuronidase | 0, 1, 2, 4, 6, 8 and 24 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability, Pharmacokinetics, Curcumin, Demethoxycurcumin, Bisdemethoxycurcumin