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Increasing the Oral Bioavailability of 6-prenylnaringenin by Micellar Solubilization

NCT03286777 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-10-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Universität Tübingen

    collaborator OTHER

  • University of Hohenheim

    lead OTHER

Principal Investigators

  • Jan Frank, Prof. Dr. · University of Hohenheim

  • Sascha Venturelli, Dr. med. Dr. rer. nat. · University Hospital, Eberhard Karls University Tuebingen, Germany

  • Christian Busch, Dr. med. · University Hospital, Eberhard Karls University Tuebingen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-22
Primary Completion
2017-12-31
Completion
2018-07-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03286777 on ClinicalTrials.gov