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The study is designed to explore the pharmacokinetics of a Plant-based ingredient in two different matrices, at different dose levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No added Plant-based ingredient | Placebo Comparator | No Plant-based ingredient added to starchy meal |
|
| Low dose added to starchy meal | Active Comparator | Plant-based ingredient in low dose added to starchy meal |
|
| High dose added to starchy meal | Active Comparator | Plant-based ingredient in high dose added to starchy meal |
|
| Low dose added to liquid | Active Comparator | Plant-based ingredient in low dose added to liquid |
|
| High dose added to liquid | Active Comparator | Plant-based ingredient in high dose added to liquid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant-based ingredient added to starchy meal | Dietary Supplement |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| AUC of the plant based ingredient calculated by a non-compartmental model | predose, 15min, 30min, 45min, 1h, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of the plant based ingredient calculated by a compartmental model | predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs. | |
| Urinary excretion of Plant-based ingredient | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of the plant based ingredient calculated by a population model | predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs. | |
| Describe the time course of the effect on glucose and insulin levels in response to the intake of plant based ingredient |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins OPTIMED | Gierre | France |
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| Plant-based ingredient added to liquid |
| Dietary Supplement |
|
| No Plant-based ingredient | Dietary Supplement |
|
| predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs. |
| +iAUC Blood glucose | 120 minutes and 180 minutes |
| +iAUC Insulin | 120 minutes and 180 minutes |