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| Name | Class |
|---|---|
| Isura | OTHER |
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Differences in metabolites of dihydroberberine (DHB) and micellar berberine (LipoMicel®, LMB) are investigated through a randomized study involving human volunteers. Over a 24-hour period, blood samples are collected and subjected to Ultra High-Performance Liquid Chromatography-High Resolution Mass Spectrometry (UHPLC-HRMS) analysis to quantify the concentrations of berberine and its metabolites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMB (LipoMicel Berberine) | Experimental |
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| DHB (Dihydroberberine) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMB | Other | A baseline blood sample (t=0) is collected from each participant prior to the intervention (LMB), and subsequent blood samples are collected at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC: the area under the concentration-time curve | For each berberine metabolite, PK parameters such as Area Under Curve (AUC) of the blood concentrations over a 24-hour period are reported. | at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention. |
| Cmax: the maximum blood concentration | For each berberine metabolite, PK parameters such as the maximum blood concentration (Cmax) are reported. | at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention. |
| Tmax: the time at which Cmax is reached | For each berberine metabolite, PK parameters such as Tmax, the time at which Cmax is reached, are reported. | at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISURA | Burnaby | British Columbia | V3N 4S9 | Canada |
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| ID | Term |
|---|---|
| C039639 | dihydroberberine |
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| DHB | Other | A baseline blood sample (t=0) is collected from each participant prior to the intervention (DHB), and subsequent blood samples are collected at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention. |
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