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| Name | Class |
|---|---|
| Universität Tübingen | OTHER |
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Micellar encapsulation will be tested to increase the oral bioavailability in humans of 6-prenylnaringenin (6-PN) from hops (Humulus lupulus). The study follows a single dose (250 mg 6-PN), placebo controlled, randomized, double-blind, three armed crossover study design with ≥2-week washout periods. Plasma, urine and PBMC samples will be collected at intervals up to 24 h after intake of the native compound, the micellar formulation or placebo. The safety, pharmacokinetics and impact of oral prenylflavonoids on PBMC survival will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Mannitol and silicon dioxide |
|
| Native 6-prenylnaringenin | Experimental | 250 mg native 6-PN plus mannitol and silicon dioxide |
|
| Micellar 6-prenylnaringenin | Experimental | 250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Mannitol and silicon dioxide capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean area under the curve (AUC) of plasma concentration vs. time of total 6-PN [nmol/L*h] | Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase | 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose |
| Mean maximum plasma concentration (Cmax) of total 6-PN [nmol/L] | Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase | 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose |
| Time to reach maximum plasma concentration (Tmax) of total 6-PN [h] | Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase | 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose |
| Cumulative urinary excretion of total 6-PN [nmol/g creatinine] | Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase | 0 h - 24 h post dose |
| Cell count (dead cells/ml and living cells/ml) of PBMCs after 6-PN administration | 0 h, 6 h, and 24 h post dose | |
| Cell viability of PBMCs after 6-PN administration | 0 h, 6 h, and 24 h post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Serum aspartate transaminase activity [U/L] | 0 h, 4 h, 24h post-dose | |
| Serum alanine transaminase activity [U/L] | 0 h, 4 h, 24h post-dose | |
| Serum gamma-glutamyl transferase activity [U/L] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Frank, Prof. Dr. | University of Hohenheim | Principal Investigator |
| Sascha Venturelli, Dr. med. Dr. rer. nat. | University Hospital, Eberhard Karls University Tuebingen, Germany | Principal Investigator |
| Christian Busch, Dr. med. | University Hospital, Eberhard Karls University Tuebingen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hohenheim | Stuttgart | Baden-Wurttemberg | 70599 | Germany | ||
| Eberhard Karls University Tuebingen |
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| Label | URL |
|---|---|
| Website of the research group | View source |
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| Native 6-prenylnaringenin |
| Dietary Supplement |
250 mg native 6-PN plus mannitol and silicon dioxide capsules |
|
| Micellar 6-prenylnaringenin | Dietary Supplement | 250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant capsules |
|
| 0 h, 4 h, 24h post-dose |
| Serum alkaline phosphatase activity [U/L] | 0 h, 4 h, 24h post-dose |
| Serum bilirubin | 0 h, 4 h, 24h post-dose |
| Serum uric acid [mg/dL] | 0 h, 4 h, 24h post-dose |
| Serum creatinine [mg/dL] | 0 h, 4 h, 24h post-dose |
| Serum total cholesterol [mg/dL] | 0 h, 4 h, 24h post-dose |
| Serum HDL cholesterol [mg/dL] | 0 h, 4 h, 24h post-dose |
| Serum LDL cholesterol [mg/dL] | 0 h, 4 h, 24h post-dose |
| Serum triacylglycerols [mg/dL] | 0 h, 4 h, 24h post-dose |
| LDL/HDL cholesterol ratio | 0 h, 4 h, 24h post-dose |
| Glomerular filtration rate [mL/min] | 0 h, 4 h, 24h post-dose |
| Serum glucose [mg/dL] | 0 h, 4 h, 24h post-dose |
| Hemoglobin [g/dL] | 0 h, 24 h post-dose |
| Mean corpuscular hemoglobin concentration [g/dL] | 0 h, 24 h post-dose |
| Mean corpuscular hemoglobin [pg] | 0 h, 24 h post-dose |
| Mean corpuscular volume [fL] | 0 h, 24 h post-dose |
| Hematocrit [%] | 0 h, 24 h post-dose |
| Erythrocytes [/pL] | 0 h, 24 h post-dose |
| Thrombocytes [/nL] | 0 h, 24 h post-dose |
| Leucocytes [/nL] | 0 h, 24 h post-dose |
| Tübingen |
| Baden-Wurttemberg |
| 72076 |
| Germany |