Improved Oral Bioavailability of Curcumin Incorporated Into Micelles

University of Hohenheim

Status and phase: Completed; Early Phase 1

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

Treatments: Dietary Supplement: curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT01982734

051113-HS2

Details and patient eligibility

About

Curcumin, a lipophilic polyphenol derived from the plant curcuma longa possesses numerous health-promoting activities. The oral bioavailability of curcumin is low due to its poor aqueous solubility, limited gastrointestinal absorption, rapid metabolism and excretion. Therefore, we tested, in a randomized crossover study, simultaneous application of phytochemicals and micellar solubilisation, alone and together, as strategies to enhance the absorption of curcumin into the body. Furthermore, we investigated age and sex differences in curcumin pharmacokinetics.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers with routine blood chemistry values within the normal ranges
• Age: 18-35 years or > 60 years

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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23 participants in 4 patient groups

Native curcumin

Active Comparator group

Description:

80 mg curcumin as native powder

Treatment:

Dietary Supplement: curcumin

Native curcumin plus phytochemicals

Experimental group

Description:

80 mg curcumin as native powder plus 80 mg sesamin, 40 mg naringenin, 40 mg ferulic acid and 40 mg xanthohumol

Treatment:

Dietary Supplement: curcumin

Curcumin micelles

Experimental group

Description:

80 mg curcumin incorporated into liquid micelles

Treatment:

Dietary Supplement: curcumin

Curcumin micelles plus phytochemicals

Experimental group

Description:

80 mg curcumin incorporated into liquid micelles plus 80 mg sesamin, 40 mg naringenin, 40 mg ferulic acid, 40 mg xanthohumol incorporated into micelles

Treatment:

Dietary Supplement: curcumin