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Oral Bioavailability and Bioactivity of Prenylflavonoids From Hops

NCT03140397 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-03-30

No results posted yet for this study

Summary

The prenylflavonoids 6-prenylnaringenin (6-PN) and 8-prenylnaringenin (8-PN) are secondary plant substances, almost exclusively found in hops (Humulus lupulus). Both compounds have known potential biological properties, but poor bioavailability due to their low oral absorption and retention. Our study followed a single dose (500 mg 6- or 8-PN), placebo controlled, randomized, double-blind, three armed crossover study design with ≥2-week washout periods. Plasma, PBMC and urine samples were collected at intervals up to 24 h after intake. Investigators investigated the safety, pharmacokinetics and impact of oral prenylflavonoids on the function of cells of the immune system.

Conditions

  • Safety After Oral Intake
  • Pharmacokinetics After Oral Intake
  • Immune Cells Activity

Interventions

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

6-prenylnaringenin

DIETARY_SUPPLEMENT

8-prenylnaringenin

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. · Eberhard Karls University Tuebingen

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

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
2016-01-31
Primary Completion
2017-04-30
Completion
2017-12-31

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 NCT03140397 on ClinicalTrials.gov