Completed

Examination of the Bioavailability and Bioactivity of the Two Natural Food Ingredients 6-Prenylnaringenin and 8-Prenylnaringenin.

What is being tested

Placebo

+ 6-prenylnaringenin

+ 8-prenylnaringenin

Dietary Supplement

Who is being recruted

From 18 to 45 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-ControlledEarly Phase 1

Interventional

Study Start: January 2016

See protocol details

Summary

Principal SponsorUniversity of Hohenheim

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleExamination of the Bioavailability and Bioactivity of the Two Natural Food Ingredients 6-Prenylnaringenin and 8-Prenylnaringenin.

NCT03140397

Principal SponsorUniversity of Hohenheim

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate

Healthy Volunteers with blood chemistry values within normal ranges

Age: 18-45 years

BMI: 19-25 kg/m2

8 exclusion criteria prevent from participating

Pregnancy or lactation

Alcohol and/or drug abuse

Use of dietary supplements or any medications, except contraceptives

Any known malignant, metabolic and endocrine diseases

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo

Capsules filled with mannitol and silicon dioxide

Group II

Experimental

500 mg 6-PN plus mannitol and silicon dioxide

Group III

Experimental

500 mg 8-PN plus mannitol and silicon dioxide

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

University of Hohenheim

Stuttgart, GermanyOpen University of Hohenheim in Google Maps

Suspended

Eberhard Karls University Tuebingen

Tübingen, Germany

Completed2 Study Centers