| Registry | NCT03286777 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, crossover, masking: double, basic science |
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| Enrollment | 6 (Actual) |
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| Sponsor | University of Hohenheim (Other); collaborators: Universität Tübingen |
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| Conditions | Safety of Native vs. Micellar 6-PN After Oral Intake, Pharmacokinetics of Native vs. Micellar 6-PN After Oral Intake, PBMC Activity After Native vs. Micellar 6-PN Oral Intake |
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| Interventions | Placebo, Native 6-prenylnaringenin, Micellar 6-prenylnaringenin (Dietary supplement) |
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| Dates | start 2017-06-22, primary completion 2017-12-31, completion 2018-07-01, first posted 2017-09-18, last updated 2018-10-10 |
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| Locations | 2 sites in Germany |
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All trials for Safety of Native vs. Micellar 6-PN After Oral Intake All trials for Pharmacokinetics of Native vs. Micellar 6-PN After Oral Intake All trials of Placebo All trials of Native 6-prenylnaringenin
-Summary
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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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo | Mannitol and silicon dioxide |
| Native 6-prenylnaringenin | Experimental | Dietary Supplement: Native 6-prenylnaringenin | 250 mg native 6-PN plus mannitol and silicon dioxide |
| Micellar 6-prenylnaringenin | Experimental | Dietary Supplement: Micellar 6-prenylnaringenin | 250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant |
- Placebo (Dietary supplement): Mannitol and silicon dioxide capsules
- 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
+Outcome measures
Primary outcomes
- Mean area under the curve (AUC) of plasma concentration vs. time of total 6-PN [nmol/L*h] [0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose]: Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase
- Mean maximum plasma concentration (Cmax) of total 6-PN [nmol/L] [0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose]: Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase
- Time to reach maximum plasma concentration (Tmax) of total 6-PN [h] [0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose]: Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase
- Cumulative urinary excretion of total 6-PN [nmol/g creatinine] [0 h - 24 h post dose]: Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase
- 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]
Secondary outcomes
- 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] [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]
+Eligibility
Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers
Inclusion Criteria:
* Healthy volunteers with blood chemistry values within normal ranges
* Age: 18-45 years
* BMI: 19-25 kg/m2
Exclusion Criteria:
* Pregnancy or lactation
* Alcohol and/or drug abuse
* Use of dietary supplements or any medications, except contraceptives
* Any known malignant, metabolic and endocrine diseases
* Previous cardiac infarction
* Dementia
* Participation in a clinical trial within the past 6 weeks prior to recruitment
* Physical activity of more than 5 h/wk
+Locations (2)
| Facility | City | Country | Status |
|---|
| University of Hohenheim | Stuttgart, Baden-Wurttemberg | Germany | |
| Eberhard Karls University Tuebingen | Tübingen, Baden-Wurttemberg | Germany | |
+Investigators
- Jan Frank, Prof. Dr., Principal investigator, University of Hohenheim
- Sascha Venturelli, Dr. med. Dr. rer. nat., Principal investigator, University Hospital, Eberhard Karls University Tuebingen, Germany
- Christian Busch, Dr. med., Principal investigator, University Hospital, Eberhard Karls University Tuebingen, Germany