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This study is designed to identify the minimal effective tested dose of fruit extract consumed with a bread which provides a reduction in venous post-prandial blood glucose compared to a reference bread.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference | Placebo Comparator | No added fruit extract |
|
| Active 1 | Active Comparator | lowest dose of fruit extract |
|
| Active 2 | Active Comparator | low dose of fruit extract |
|
| Active 3 | Active Comparator | medium dose of fruit extract |
|
| Active 4 | Active Comparator | high dose of fruit extract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no added fruit extract | Dietary Supplement |
| ||
| fruit extract |
| Measure | Description | Time Frame |
|---|---|---|
| Positive incremental post-prandial blood glucose area under the curve | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Post-prandial insulin response | 120 minutes | |
| Post-prandial insulin response | 180 minutes | |
| AUC of fruit extract calculated by a non-compartmental model |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité research organisation | Berlin | Charitéplatz 1 | 10117 | Germany |
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|
| fruit extract | Dietary Supplement |
|
| fruit extract | Dietary Supplement |
|
| fruit extract | Dietary Supplement |
|
| 180 minutes |
| AUC of fruit extract calculated by a population model | 180 minutes |
| Positive incremental post-prandial blood glucose area under the curve | 180 minutes |
| ID | Term |
|---|---|
| D005638 | Fruit |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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