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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621865 on ClinicalTrials.gov