Comparison of Curcumin Bioavailability

University of Hohenheim

Status

Completed

Conditions

Safety After Oral Intake

Pharmacokinetics After Oral Intake

Treatments

Dietary Supplement: Phytosomal curcumin

Dietary Supplement: Cyclodextrin complex of curcuminoids

Dietary Supplement: Native turmeric extract

Dietary Supplement: Micellar turmeric extract

Dietary Supplement: Turmeric oleoresin

Dietary Supplement: Liposomal curcumin

Dietary Supplement: Turmeric extract plus mixture of phytochemicals

Dietary Supplement: Native turmeric extract with 7-9% volatile turmeric oils

Study type

Interventional

Funder types

Other

Identifiers

NCT03530436

HS-CUV-2018

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

12 participants in 8 patient groups

Native turmeric extract

Other group

Description:

6 capsules of native curcumin (207 mg curcumin)

Treatment:

Dietary Supplement: Native turmeric extract

Native turmeric extract with 7-9% volatile turmeric oils

Experimental group

Description: