Increasing the Oral Bioavailability of 6-prenylnaringenin by Micellar Solubilization

October 9, 2018 updated by: University of Hohenheim
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Stuttgart, Baden-Württemberg, Germany, 70599
        • University of Hohenheim
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Eberhard Karls University Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Mannitol and silicon dioxide
Dietary supplement: Placebo
Mannitol and silicon dioxide capsules
Experimental: Native 6-prenylnaringenin
250 mg native 6-PN plus mannitol and silicon dioxide
Dietary supplement: Native 6-prenylnaringenin
250 mg native 6-PN plus mannitol and silicon dioxide capsules
Experimental: Micellar 6-prenylnaringenin
250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant
Dietary supplement: Micellar 6-prenylnaringenin
250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean area under the curve (AUC) of plasma concentration vs. time of total 6-PN [nmol/L*h]
Time Frame: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose
Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase
0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose
Mean maximum plasma concentration (Cmax) of total 6-PN [nmol/L]
Time Frame: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose
Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase
0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose
Time to reach maximum plasma concentration (Tmax) of total 6-PN [h]
Time Frame: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose
Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase
0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose
Cumulative urinary excretion of total 6-PN [nmol/g creatinine]
Time Frame: 0 h - 24 h post dose
Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase
0 h - 24 h post dose
Cell count (dead cells/ml and living cells/ml) of PBMCs after 6-PN administration
Time Frame: 0 h, 6 h, and 24 h post dose
0 h, 6 h, and 24 h post dose
Cell viability of PBMCs after 6-PN administration
Time Frame: 0 h, 6 h, and 24 h post dose
0 h, 6 h, and 24 h post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Serum aspartate transaminase activity [U/L]
Time Frame: 0 h, 4 h, 24h post-dose
0 h, 4 h, 24h post-dose
Serum alanine transaminase activity [U/L]
Time Frame: 0 h, 4 h, 24h post-dose
0 h, 4 h, 24h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Time Frame: 0 h, 4 h, 24h post-dose
0 h, 4 h, 24h post-dose
Serum alkaline phosphatase activity [U/L]
Time Frame: 0 h, 4 h, 24h post-dose
0 h, 4 h, 24h post-dose
Serum bilirubin
Time Frame: 0 h, 4 h, 24h post-dose
0 h, 4 h, 24h post-dose
Serum uric acid [mg/dL]
Time Frame: 0 h, 4 h, 24h post-dose
0 h, 4 h, 24h post-dose
Serum creatinine [mg/dL]
Time Frame: 0 h, 4 h, 24h post-dose
0 h, 4 h, 24h post-dose
Serum total cholesterol [mg/dL]
Time Frame: 0 h, 4 h, 24h post-dose
0 h, 4 h, 24h post-dose
Serum HDL cholesterol [mg/dL]
Time Frame: 0 h, 4 h, 24h post-dose
0 h, 4 h, 24h post-dose
Serum LDL cholesterol [mg/dL]
Time Frame: 0 h, 4 h, 24h post-dose
0 h, 4 h, 24h post-dose
Serum triacylglycerols [mg/dL]
Time Frame: 0 h, 4 h, 24h post-dose
0 h, 4 h, 24h post-dose
LDL/HDL cholesterol ratio
Time Frame: 0 h, 4 h, 24h post-dose
0 h, 4 h, 24h post-dose
Glomerular filtration rate [mL/min]
Time Frame: 0 h, 4 h, 24h post-dose
0 h, 4 h, 24h post-dose
Serum glucose [mg/dL]
Time Frame: 0 h, 4 h, 24h post-dose
0 h, 4 h, 24h post-dose
Hemoglobin [g/dL]
Time Frame: 0 h, 24 h post-dose
0 h, 24 h post-dose
Mean corpuscular hemoglobin concentration [g/dL]
Time Frame: 0 h, 24 h post-dose
0 h, 24 h post-dose
Mean corpuscular hemoglobin [pg]
Time Frame: 0 h, 24 h post-dose
0 h, 24 h post-dose
Mean corpuscular volume [fL]
Time Frame: 0 h, 24 h post-dose
0 h, 24 h post-dose
Hematocrit [%]
Time Frame: 0 h, 24 h post-dose
0 h, 24 h post-dose
Erythrocytes [/pL]
Time Frame: 0 h, 24 h post-dose
0 h, 24 h post-dose
Thrombocytes [/nL]
Time Frame: 0 h, 24 h post-dose
0 h, 24 h post-dose
Leucocytes [/nL]
Time Frame: 0 h, 24 h post-dose
0 h, 24 h post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Hohenheim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universität Tübingen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan Frank, Prof. Dr., University of Hohenheim
  • Principal Investigator: Sascha Venturelli, Dr. med. Dr. rer. nat., University Hospital, Eberhard Karls University Tuebingen, Germany
  • Principal Investigator: Christian Busch, Dr. med., University Hospital, Eberhard Karls University Tuebingen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS-PF2-2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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