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| Name | Class |
|---|---|
| University of Hohenheim | OTHER |
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The aim of this study is to investigate the rate and extend of the plasma appearance of native Xanthohumol and Xanthohumol integrated into micelles in healthy men and women. Therefore, participants consume capsules with either 86 or 172 mg of native Xanthohumol or Xanthohumol integrated into micelles. In an observation period of 24 hours, Xanthohumol and its major metabolites are analyzed in plasma.
In a crossover design, 6 healthy young men and 6 healthy young women participate in 4 Xanthohumol interventions with either 86 or 172 mg native or micellar solubilized Xanthohumol. During an observation period of 24 hours, Xanthohumol and its major metabolites Isoxanthohumol, 8- and 6-Prenylnaringenin are analyzed in plasma. Each intervention will be separated by a wash-out period of 14 days. Typical plasmakinetic analyses (Cmax, tmax, AUC, t1/2, bioavailability) will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| solubilized Xanthohumol low dose | Experimental | single dose of 86 mg micellar solubilized Xanthohumol |
|
| solubilized Xanthohumol high dose | Experimental | single dose of 172 mg micellar solubilized Xanthohumol |
|
| native Xanthohumol low dose | Active Comparator | single dose of 86 mg native Xanthohumol |
|
| native Xanthohumol high dose | Active Comparator | single dose of 172 mg native Xanthohumol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| solubilized Xanthohumol low dose | Dietary Supplement | single administration of 2 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol and 2 soft gelatine capsules containing only micelles |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic exposure to Xanthohumol | Mean area under the curve (AUC) of plasma concentration vs. time of total Xanthohumol (nmol/L*h) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose |
| Cmax Xanthohumol | Mean maximum plasma concentration of total Xanthohumol (nmol/L) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose |
| tmax Xanthohumol | Time to reach maximum plasma concentration of total Xanthohumol [h] | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose |
| Oral bioavailability Xanthohumol | Minimum bioavailable amount of the ingested compound (%) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic exposure to Xanthohumol glucuronides | Mean area under the curve (AUC) of plasma concentration vs. time of Xanthohumol glucuronides (nmol/L*h) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose |
| Systemic exposure to Xanthohumol sulfates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Egert, Prof PhD | University of Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bonn | Bonn | 53115 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41723719 | Derived | Brehmer-Henkel S, Diekmann C, Eickeler M, Maris R, Kopp C, Coenen M, Nemeth R, Stoffel-Wagner B, Sus N, Frank J, Egert S. The Bioavailability of Xanthohumol in Humans and the Influence of Formulation and Dose: Randomized Controlled Trial Data. Mol Nutr Food Res. 2026 Feb;70(4):e70413. doi: 10.1002/mnfr.70413. |
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| solubilized Xanthohumol high dose | Dietary Supplement | single administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol |
|
| native Xanthohumol low dose | Dietary Supplement | single administration of 2 hard gelatine capsules each containing 43 mg native Xanthohumol and 2 hard gelatine capsules containing silicon dioxide |
|
| native Xanthohumol high dose | Dietary Supplement | single administration of 4 hard gelatine capsules each containing 43 mg native Xanthohumol |
|
Mean area under the curve (AUC) of plasma concentration vs. time of Xanthohumol sulfates (nmol/L*h) |
| 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose |
| Systemic exposure to free Xanthohumol | Mean area under the curve (AUC) of plasma concentration vs. time of free Xanthohumol (nmol/L*h) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose |
| Cmax Xanthohumol glucuronides | Mean maximum plasma concentration of Xanthohumol glucuronides (nmol/L) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose |
| Cmax Xanthohumol sulfates | Mean maximum plasma concentration of Xanthohumol sulfates (nmol/L) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose |
| Cmax free Xanthohumol | Mean maximum plasma concentration of free Xanthohumol (nmol/L) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose |
| tmax Xanthohumol glucuronides | Time to reach maximum plasma concentration of Xanthohumol glucuronides [h] | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose |
| tmax Xanthohumol sulfates | Time to reach maximum plasma concentration of Xanthohumol sulfates [h] | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose |
| tmax free Xanthohumol | Time to reach maximum plasma concentration of free Xanthohumol [h] | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose |