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This study is designed to test bioequivalence of a assumed key active compound vs. natural fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for assumed key active compound vs. natural extract falls between 0.8 - 1.25.
The basic study design for this Williams design consists of six distinct treatment sequences; within each of the treatment sequences the treatments are duplicated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Rice only |
|
| Assumed active | Active Comparator | Assumed key active consumed with rice |
|
| Natural fruit extract | Active Comparator | Natural fruit extract consumed with rice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural fruit extract | Other | Natural fruit extract consumed with rice |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of 2-h Post Prandial Blood Glucose (PPG) based on response to different treatments | +iAUC | 0-2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change of 3-h PPG based on response to different treatments | +iAUC | 0-3 hours |
| Change of 2-h and 3-h post-prandial insulin based on response to different treatments | tAUC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Keicher, Dr | Charité Research Organisation GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Research Organisation GmbH | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40419090 | Derived | Hoogenraad AR, Geldof M, Hiemstra H, de Jong A, Duchateau GS, Mela DJ. Bioequivalence of Mulberry Fruit Extract and 1-Deoxynojirimycin for Postprandial Blood Glucose Lowering: A Randomized Trial in Humans. J Nutr. 2025 Jul;155(7):2164-2171. doi: 10.1016/j.tjnut.2025.05.037. Epub 2025 May 24. |
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| Assumed active |
| Other |
Assumed key active consumed with rice |
|
| Placebo | Other | Rice only |
|
| 0-2 hours and 0-3 hours |
| Max plasma concentration for assumed key active | Cmax | 0-12 hours |
| Time of max plasma concentration for assumed key active | Tmax | 0-12 hours |
| AUC for plasma concentration versus time curve for assumed key active | AUC | 0-12 hours |
| Half-life of elimination phase for assumed key active | t1/2 | 0-12 hours |
| Total amount of assumed key active excreted in urine | 0-36 hours |