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Oral Bioavailability and Bioactivity of Prenylflavonoids From Hops

NCT ID: NCT03140397

Last Updated: 2018-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Safety After Oral Intake Pharmacokinetics After Oral Intake Immune Cells Activity

Keywords

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Bioavailability Pharmacokinetics 8-prenylnaringenin 6-prenylnaringenin Prenylflavonoids PBMC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Capsules filled with mannitol and silicon dioxide

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

6-prenylnaringenin

500 mg 6-PN plus mannitol and silicon dioxide

Group Type EXPERIMENTAL

6-prenylnaringenin

Intervention Type DIETARY_SUPPLEMENT

8-prenylnaringenin

500 mg 8-PN plus mannitol and silicon dioxide

Group Type EXPERIMENTAL

8-prenylnaringenin

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Placebo

Intervention Type DIETARY_SUPPLEMENT

6-prenylnaringenin

Intervention Type DIETARY_SUPPLEMENT

8-prenylnaringenin

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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6-PN 8-PN

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universität Tübingen

OTHER

Sponsor Role collaborator

University of Hohenheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Frank, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Hohenheim

Sascha Venturelli, Dr. med. Dr. rer. nat.

Role: PRINCIPAL_INVESTIGATOR

Eberhard Karls University Tuebingen

Christian Busch, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Eberhard Karls University Tuebingen

Locations

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University of Hohenheim

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Eberhard Karls University Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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Calvo-Castro LA, Burkard M, Sus N, Scheubeck G, Leischner C, Lauer UM, Bosy-Westphal A, Hund V, Busch C, Venturelli S, Frank J. The Oral Bioavailability of 8-Prenylnaringenin from Hops (Humulus Lupulus L.) in Healthy Women and Men is Significantly Higher than that of its Positional Isomer 6-Prenylnaringenin in a Randomized Crossover Trial. Mol Nutr Food Res. 2018 Apr;62(7):e1700838. doi: 10.1002/mnfr.201700838. Epub 2018 Mar 1.

Reference Type DERIVED
PMID: 29363261 (View on PubMed)

Related Links

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http://www.nutrition-research.de/

Website of the research group

Other Identifiers

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HS-PF1-2016

Identifier Type: -

Identifier Source: org_study_id