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| Name | Class |
|---|---|
| Biofortis Mérieux NutriSciences | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subject sequence 1 | Experimental | subject allocation sequence 1. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
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| subject sequence 2 | Experimental | subject allocation sequence 2. IIntervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
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| subject sequence 3 | Experimental | subject allocation sequence 3. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
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| subject sequence 4 | Experimental | subject allocation sequence 4. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TG | Dietary Supplement | Turmipure GOLD™ 30% curcuminoids (300 mg) |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-normalized AUC of total curcuminoids plasmatic concentration | The primary endpoint is the dose-normalized AUC of total curcuminoids (sum of curcumin, DMC, BDMC and their metabolites) plasmatic concentration from 0 to 24 hours (AUC0-24h/dose) (expressed in µg.h/mL/mg). The dose-normalized AUC is the AUC normalized to curcuminoids intake by dividing the observed AUC by the corresponding curcuminoids dosage of each administration The following time-points are considered: T0, T15, T30, T45, T60, T90, T120, T240, T60, T480, T24H. T-10 will be considered as baseline value (T0) for AUC calculation. The primary comparison is Turmipure Gold 300 mg vs Standard turmeric 1500 mg powder extract. | from 0 to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of total curcuminoids plasmatic concentration | AUC of total curcuminoids plasmatic concentration from 0 to 24 hours (AUC0-24h, expressed in µg.h/mL); | from 0 to 24 hours |
| AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations |
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Inclusion Criteria:
Exclusion Criteria:
After V0 biological analyses the subject will be considered as non-eligible to the study on the following criteria:
- Control record (Glycaemia, GGT, ASAT, ALAT, Urea, Creatinine and Complete blood count) with clinically significant abnormality according to the investigator
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| Name | Affiliation | Role |
|---|---|---|
| Pascale Fança-Berthon, PhD | Naturex | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Mérieux NutriSciences | Saint-Herblain | 44800 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33877323 | Derived | Fanca-Berthon P, Tenon M, Bouter-Banon SL, Manfre A, Maudet C, Dion A, Chevallier H, Laval J, van Breemen RB. Pharmacokinetics of a Single Dose of Turmeric Curcuminoids Depends on Formulation: Results of a Human Crossover Study. J Nutr. 2021 Jul 1;151(7):1802-1816. doi: 10.1093/jn/nxab087. |
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| ID | Term |
|---|---|
| C072829 | tetraethylpyrazine |
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This pharmacokinectic study is designed as a monocentric, randomized, cross-over, pilot and open clinical trial
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| subject sequence 5 | Experimental | subject allocation sequence 5. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
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| subject sequence 6 | Experimental | subject allocation sequence 6. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
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| subject sequence 7 | Experimental | subject allocation sequence 7. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
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| subject sequence 8 | Experimental | subject allocation sequence 8. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
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| subject sequence 9 | Experimental | subject allocation sequence 9. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
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| subject sequence 10 | Experimental | subject allocation sequence 10. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
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| STE | Dietary Supplement | Standard turmeric powder extract 95% curcuminoids (1500 mg) |
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| NOV | Dietary Supplement | Novasol® Liquid micellar formulation 6% curcuminoids (1000 mg) |
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| PHYT | Dietary Supplement | Meriva® Turmeric Phytosome formulation 20% curcuminoids (1000 mg) |
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| TEP | Dietary Supplement | Turmeric extract C3 complex® 95% curcuminoids (1500mg) + BioPerine® 95% piperine (15 mg) |
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AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations from 0 to 24 hours (AUC0-24h, expressed in µg.h/mL); |
| from 0 to 24 hours |
| AUC of curcuminoids metabolites plasmatic concentrations | AUC of curcuminoids metabolites plasmatic concentrations from 0 to 24 hours (AUC0-24h, expressed in µg.h/mL); | from 0 to 24 hours |
| AUC of total curcuminoids plasmatic concentration normalized to curcuminoids intake | AUC of total curcuminoids plasmatic concentration from 0 to 8 hours normalized to curcuminoids intake (AUC0-8h/dose, expressed in µg.h/mL/mg); | from 0 to 8 hours |
| AUC of total curcuminoids plasmatic concentration | AUC of total curcuminoids plasmatic concentration from 0 to 8 hours (AUC0-8h) (expressed in µg.h/mL); | from 0 to 8 hours |
| AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations | AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations from 0 to 8 hours (AUC0-8h, expressed in µg.h/mL); | from 0 to 8 hours |
| AUC of curcuminoids metabolites plasmatic concentrations | AUC of curcuminoids metabolites plasmatic concentrations from 0 to 8 hours (AUC0-8h, expressed in µg.h/mL); | from 0 to 8 hours |
| AUC of total curcuminoids plasmatic concentration normalized to curcuminoids intake | AUC of total curcuminoids plasmatic concentration from 0 to infinity normalized to curcuminoids intake (AUC0-infinity/dose, expressed in µg.h/mL/mg); | from 0 to infinity |
| AUC of total curcuminoids plasmatic concentration | AUC of total curcuminoids plasmatic concentration from 0 to infinity (AUC0-infinity, expressed in µg.h/mL); | from 0 to infinity |
| AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations | AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations from 0 to infinity (AUC0-infinity, expressed in µg.h/mL); | from 0 to infinity |
| AUC of curcuminoids metabolites plasmatic concentrations | AUC of curcuminoidsmetabolites plasmatic concentrations from 0 to infinity (AUC0-infinity, expressed in µg.h/mL); | from 0 to infinity |
| Peak of total curcuminoids plasmatic concentration normalized to curcuminoids intake | Peak of total curcuminoids plasmatic concentration normalized to curcuminoids intake (Cmax/dose, expressed in µg/mL/mg); | 24hours |
| Peak of total curcuminoids plasmatic concentration | Peak of total curcuminoids plasmatic concentration (Cmax, expressed in µg/mL); | 24hours |
| Peak of curcuminoids separately plasmatic concentrations | Peak of curcuminoids separately plasmatic concentrations (Cmax, expressed in µg/mL); | 24hours |
| Peak of curcuminoids metabolites plasmatic concentrations | Peak of curcuminoids metabolites plasmatic concentrations (Cmax, expressed in µg/mL); | 24hours |
| Half-life of total curcuminoids in plasma | Half-life of total curcuminoids in plasma (t1/2, expressed in minutes); | 24hours |
| Half-life of curcuminoids separately (curcumin, DMC, BDMC) in plasma | Half-life of curcuminoids separately (curcumin, DMC, BDMC) in plasma (t1/2, expressed in minutes); | 24hours |
| Half-life of curcuminoids metabolites in plasma | Half-life of curcuminoids metabolites in plasma (t1/2, expressed in minutes); | 24hours |
| Terminal elimination rate constant of total curcuminoids in plasma (λz) | Terminal elimination rate constant of total curcuminoids in plasma (λz); | 24hours |
| Terminal elimination rate constant curcuminoids separately (curcumin, DMC, BDMC) in plasma (λz) | Terminal elimination rate constant curcuminoids separately (curcumin, DMC, BDMC) in plasma (λz); | 24hours |
| Terminal elimination rate constant curcuminoids metabolites in plasma (λz) | Terminal elimination rate constant curcuminoids metabolites in plasma (λz); | 24hours |
| Time to peak of total curcuminoids plasmatic concentrations | Time to peak of total curcuminoids plasmatic concentration in plasma (Tmax, expressed in minutes) | 24hours |
| Time to peak of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations | Time to peak of plasmatic concentrations curcuminoids separately (curcumin, DMC, BDMC) in plasma (Tmax, expressed in minutes); | 24hours |
| Time to peak of curcuminoids metabolites plasmatic concentrations | Time to peak of plasmatic concentrations curcuminoids metabolites in plasma (Tmax, expressed in minutes); | 24hours |
| Relative bioavailability | Relative bioavailability from 0 to 24 hours defined as the ratio of dose-normalized AUC0-24h of total curcuminoids for the different tested formulation to the dose-normalized AUC0-24h obtained for the reference product (turmeric extract 95% curcuminoids). | from 0 to 24 hours |