Trials / Completed
CompletedNCT03286777
Increasing the Oral Bioavailability of 6-prenylnaringenin by Micellar Solubilization
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- University of Hohenheim · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Placebo | Mannitol and silicon dioxide capsules |
| DIETARY_SUPPLEMENT | Native 6-prenylnaringenin | 250 mg native 6-PN plus mannitol and silicon dioxide capsules |
| DIETARY_SUPPLEMENT | Micellar 6-prenylnaringenin | 250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant capsules |
Timeline
- Start date
- 2017-06-22
- Primary completion
- 2017-12-31
- Completion
- 2018-07-01
- First posted
- 2017-09-18
- Last updated
- 2018-10-10
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03286777. Inclusion in this directory is not an endorsement.