A Comparative Pharmacokinetic Study to Evaluate the Ability of a New Formulation to Enhance Curcuminoids Bioavailability
NCT03621865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2018-11-06
Summary
The rhizome of Curcuma longa (turmeric) is commonly used as a spice and for its medicinal properties traditionally in Asian countries. Turmeric extract usually contains 95% curcuminoids with a specific ratio (approximately 75-80% curcumin, 15-20% demethoxycurcumin (DMC), and 0-10% bisdemethoxycurcumin (BDMC)).
Curcuminoids have higher solubility in organic solvents than in water. As a consequence, curcuminoids have low aqueous solubility and poor gastrointestinal absorption. They also exhibit rapid metabolism and systemic elimination and are therefore known to have limited bioavailability, which limits the use of turmeric extract in general health care and as an adjunct in managing various diseases. In order to improve the bioavailability of curcumin, several approaches have been undertaken. The use of adjuvant like piperine that interferes with glucuronidation; liposomal curcumin, nanoparticles, phospholipid complex; and structural analogues of curcumin.
Recently, Naturex has developed a dried emulsion formulation using a turmeric extract mixed together with a quillaja extract, sunflower oil and arabic gum. This formulation is highly dispersible in water and should therefore improve the bioavailability of curcuminoids. The aim of this study is to assess the bioavailability of curcuminoids and their metabolites after oral intake of 4 turmeric extract-based formulations in comparison to a standard unformulated turmeric extract.
Conditions
- Healthy
Interventions
- DIETARY_SUPPLEMENT
-
TG
Turmipure GOLD™ 30% curcuminoids (300 mg)
- DIETARY_SUPPLEMENT
-
STE
Standard turmeric powder extract 95% curcuminoids (1500 mg)
- DIETARY_SUPPLEMENT
-
NOV
Novasol® Liquid micellar formulation 6% curcuminoids (1000 mg)
- DIETARY_SUPPLEMENT
-
PHYT
Meriva® Turmeric Phytosome formulation 20% curcuminoids (1000 mg)
- DIETARY_SUPPLEMENT
-
TEP
Turmeric extract C3 complex® 95% curcuminoids (1500mg) + BioPerine® 95% piperine (15 mg)
Sponsors & Collaborators
-
Biofortis Mérieux NutriSciences
collaborator OTHER -
Givaudan France Naturals
lead INDUSTRY
Principal Investigators
-
Pascale Fança-Berthon, PhD · Naturex
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-07-26
- Primary Completion
- 2018-10-26
- Completion
- 2018-10-26
Countries
- France
Study Locations
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