A Comparative Pharmacokinetic Study to Evaluate the Ability of a New Formulation to Enhance Curcuminoids Bioavailability
Condition: Healthy
Study type: Interventional

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.
    

Detailed description: 
      The rhizome of Curcuma longa (turmeric) is commonly used as a spice and for its medicinal
      proprieties traditionally in Asian countries. Turmeric has been studying in different
      therapeutic areas. Antioxidant, anti-inflammatory (respiratory system, joints and digestive),
      antimutagenic, antimicrobial, neurological disease, hepatoprotective and anticancer
      properties are supported by in vitro and in vivo data.

      Curcumin has been studied as the main bioactive component of turmeric associated to its
      potential health effect. However, besides curcumin, others components have been identified
      (demethoxycurcumin DMC and bisdemethoxycurcumin BDMC); this group of coumpounds are named
      together "curcuminoids". Curcuminoids are natural yellow-orange pigments and hydrophobic
      polyphenols derived from the rhizome of the herb Curcuma longa. They are commonly isolated
      from the spice and food-coloring agent turmeric. Extracts of turmeric generally contain
      75-80% curcumin, 15-20% DMC, and 0-10% BDMC. Regarding the intrinsic property, 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.

      This leads to the conclusion that curcuminoids from turmeric extract have low
      bioavailability, which limits its use 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.
    

Intervention name(s): TG; STE; NOV; PHYT; TEP
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Turmipure GOLD™ 30% curcuminoids (300 mg); Standard turmeric powder extract 95% curcuminoids (1500 mg); Novasol® Liquid micellar formulation 6% curcuminoids (1000 mg); Meriva® Turmeric Phytosome formulation 20% curcuminoids (1000 mg); Turmeric extract C3 complex® 95% curcuminoids (1500mg) + BioPerine® 95% piperine (15 mg)
Other intervention name(s): Turmipure GOLD™; Standard turmeric powder extract
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This pharmacokinectic study is designed as a monocentric, randomized, cross-over, pilot and open clinical trial
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioavailability; pharmacokinetic study; curcuminoids; curcumin; healthy volunteers