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| Name | Class |
|---|---|
| Biofortis Mérieux NutriSciences | OTHER |
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The objective of this study is to assess bioavailability of total gingeroids, free gingerols and shogaols, so as their glucuronide and sulfate metabolites, in the plasma, after consumption of a single dose of 5 different ginger extracts. These five extracts have the same quantity of active substance but with different titration (1.6%, 5%, 39%, 26% and 26% NOP80).
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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 (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
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| Subject sequence 2 | Experimental | Subject allocation sequence 2. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
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| Subject sequence 3 | Experimental | Subject allocation sequence 3. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tested product n°1 | Dietary Supplement | 1 capsule (26% of gingerol/shogaol in 100 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of total gingeroids plasmatic concentration | The primary endpoint is the AUC (Area Under the Curve) of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentration from 0 to 8 hours (AUC0-8h) following consumption of ginger extract (expressed in µg.h/mL) and considering the following time-points: T0 to T480. The primary comparisons are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg and Gingest TM 26% versus Ginger 1.6% 28.9 mg. | From 0 to 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-8H of total gingeroids plasmatic concentration | AUC of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations from 0 to 8 hours following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T480. Secondary comparisons are GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Romain Le Cozannet, PhD | Givaudan France Naturals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Mérieux Nutrisciences | Saint-Herblain | 44800 | France |
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| ID | Term |
|---|---|
| C018620 | oleoresins |
| C000713927 | ginger extract |
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| Subject sequence 4 | Experimental | Subject allocation sequence 4. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
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| Subject sequence 5 | Experimental | Subject allocation sequence 5. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
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| Subject sequence 6 | Experimental | Subject allocation sequence 6. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
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| Subject sequence 7 | Experimental | Subject allocation sequence 7. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
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| Subject sequence 8 | Experimental | Subject allocation sequence 8. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
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| Subject sequence 9 | Experimental | Subject allocation sequence 9. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
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| Subject sequence 10 | Experimental | Subject allocation sequence 10. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
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| Tested product n°2 | Dietary Supplement | 1 capsule (38.6% of gingerol/shogaol in 74.9 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic) |
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| Tested product n°3 | Dietary Supplement | 2 capsules (6.8% of gingerol/shogaol in 424.3 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic) |
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| Tested product n°4 | Dietary Supplement | 1 capsule (27% of gingerol/shogaol in 104.9 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic) |
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| Tested product n°5 | Dietary Supplement | 6 capsules (1.6% of gingerol/shogaol in 1806.25 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic) |
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| From 0 to 8 hours |
| AUC0-8H of each analytes of ginger plasmatic concentration separately | AUC of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations from 0 to 8 hours following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T480. Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg | From 0 to 8 hours |
| AUC0-24H of each total gingeroids plasmatic concentrations | AUC of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations from 0 to 24 hours following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H. Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg | From 0 to 24 hours |
| AUC0-24H of each analytes of ginger plasmatic concentration separately | AUC of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations from 0 to 24 hours following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H. Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg | From 0 to 24 hours |
| AUC0-∞ of each analytes of ginger plasmatic concentration separately | AUC of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations from 0 to infinity following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H. Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg | From 0 to infinity |
| AUC0-∞ of total gingeroids plasmatic concentrations | AUC of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations from 0 to infinity following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H. Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg | From 0 to infinity |
| Half-life time of total gingeroids plasmatic concentrations | Half-life time of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations following consumption of each test product (expressed in minutes). Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg | 24 hours |
| Half-life time of each analytes of ginger plasmatic concentration separately | Half-life time of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10- gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate plasmatic concentrations following consumption of each test product (expressed in minutes). Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg | 24 hours |
| Terminal elimination rate constant of each analytes of ginger plasmatic concentration separately | Terminal elimination rate constant of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10- gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations following consumption of each test product. Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg | 24 hours |
| Terminal elimination rate constant of total gingeroids plasmatic concentrations | Terminal elimination rate constant of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations following consumption of each test product. Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg | 24 hours |
| Time to peak of total gingeroids plasmatic concentrations | Time to peak of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations following consumption of each test product (expressed in minutes). Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg | 24 hours |
| Time to peak of each analytes of ginger plasmatic concentration | Time to peak of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations following consumption of each test product (expressed in minutes). Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg | 24 hours |
| Peak of each analytes of ginger plasmatic concentration | Peak of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations following consumption of each test product (expressed in µg/mL). Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg | 24 hours |
| Peak of total gingeroids plasmatic concentrations | Peak of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations following consumption of each test product (expressed in µg/mL). Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg | 24 hours |