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

University of Hohenheim

Status and phase: Completed; Early Phase 1

Conditions: Pharmacokinetics of Novel Curcumin Formulations; Safety of Novel Curcumin Formulations

Treatments: Dietary Supplement: curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT01925287

01EA1334AHS1

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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23 participants in 3 patient groups

Native curcumin powder

Active Comparator group

Description:

500 mg curcumin as native powder

Treatment:

Dietary Supplement: curcumin

Micronized curcumin powder

Experimental group

Description:

500 mg curcumin as micronized powder

Treatment:

Dietary Supplement: curcumin

Curcumin micelles

Experimental group

Description:

500 mg curcumin incorporated into liquid micelles

Treatment:

Dietary Supplement: curcumin