Safety of Native vs. Micellar 6-PN After Oral IntakeNCT03286777

Increasing the Oral Bioavailability of 6-prenylnaringenin by Micellar Solubilization

A study testing Native 6-prenylnaringenin and Micellar 6-prenylnaringenin in people with Safety of Native vs. Micellar 6-PN After Oral Intake and Pharmacokinetics of Native vs. Micellar 6-PN After Oral Intake, run by University of Hohenheim at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: 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
What is being tested?: Native 6-prenylnaringenin and Micellar 6-prenylnaringenin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6 participants
Where: 2 sitesGermany
Study dates: 22 Jun 2017to 1 Jul 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy volunteers with blood chemistry values within normal ranges
Age: 18-45 years
BMI: 19-25 kg/m2

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

University of Hohenheim
Stuttgart, Baden-Wurttemberg, 70599
Eberhard Karls University Tuebingen
Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

About this study

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
Being tested: Placebo, Native 6-prenylnaringenin, Micellar 6-prenylnaringenin
Keywords: 6-prenylnaringenin, Bioavailability, Pharmacokinetics, PBMC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDietary supplement
Mannitol and silicon dioxide capsules
Native 6-prenylnaringeninDietary supplement
250 mg native 6-PN plus mannitol and silicon dioxide capsules
Micellar 6-prenylnaringeninDietary supplement
250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant capsules

Study groups in NCT03286777
Study group	Role	What they receive
Placebo	Placebo comparator	Mannitol and silicon dioxide Receives: Dietary Supplement: Placebo
Native 6-prenylnaringenin	Experimental	250 mg native 6-PN plus mannitol and silicon dioxide Receives: Dietary Supplement: Native 6-prenylnaringenin
Micellar 6-prenylnaringenin	Experimental	250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant Receives: Dietary Supplement: Micellar 6-prenylnaringenin

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean area under the curve (AUC) of plasma concentration vs. time of total 6-PN [nmol/L*h]
Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase
Measured: 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]
Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase
Measured: 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]
Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase
Measured: 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]
Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase
Measured: 0 h - 24 h post dose
Cell count (dead cells/ml and living cells/ml) of PBMCs after 6-PN administration
Measured: 0 h, 6 h, and 24 h post dose
Cell viability of PBMCs after 6-PN administration
Measured: 0 h, 6 h, and 24 h post dose

Secondary outcomes (22)

Serum aspartate transaminase activity [U/L]
Measured: 0 h, 4 h, 24h post-dose
Serum alanine transaminase activity [U/L]
Measured: 0 h, 4 h, 24h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Measured: 0 h, 4 h, 24h post-dose
Serum alkaline phosphatase activity [U/L]
Measured: 0 h, 4 h, 24h post-dose
Serum bilirubin
Measured: 0 h, 4 h, 24h post-dose
Serum uric acid [mg/dL]
Measured: 0 h, 4 h, 24h post-dose
Serum creatinine [mg/dL]
Measured: 0 h, 4 h, 24h post-dose
Serum total cholesterol [mg/dL]
Measured: 0 h, 4 h, 24h post-dose
Serum HDL cholesterol [mg/dL]
Measured: 0 h, 4 h, 24h post-dose
Serum LDL cholesterol [mg/dL]
Measured: 0 h, 4 h, 24h post-dose
Serum triacylglycerols [mg/dL]
Measured: 0 h, 4 h, 24h post-dose
LDL/HDL cholesterol ratio
Measured: 0 h, 4 h, 24h post-dose
Glomerular filtration rate [mL/min]
Measured: 0 h, 4 h, 24h post-dose
Serum glucose [mg/dL]
Measured: 0 h, 4 h, 24h post-dose
Hemoglobin [g/dL]
Measured: 0 h, 24 h post-dose
Mean corpuscular hemoglobin concentration [g/dL]
Measured: 0 h, 24 h post-dose
Mean corpuscular hemoglobin [pg]
Measured: 0 h, 24 h post-dose
Mean corpuscular volume [fL]
Measured: 0 h, 24 h post-dose
Hematocrit [%]
Measured: 0 h, 24 h post-dose
Erythrocytes [/pL]
Measured: 0 h, 24 h post-dose
Thrombocytes [/nL]
Measured: 0 h, 24 h post-dose
Leucocytes [/nL]
Measured: 0 h, 24 h post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 20171 Jul 2018

First posted18 Sep 2017
Study start22 Jun 2017
Primary completion31 Dec 2017
Study completion1 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Safety of Native vs. Micellar 6-PN After Oral IntakeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03286777
Sponsor's protocol ID: HS-PF2-2017
Status last verified: Oct 2018
First submitted: 14 Sep 2017
Last updated: 10 Oct 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Increasing the Oral Bioavailability of 6-prenylnaringenin by Micellar Solubilization
ClinicalTrials.gov ID: NCT03286777
Acronym / sponsor ID: HS-PF2-2017
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
Keywords: 6-prenylnaringenin, Bioavailability, Pharmacokinetics, PBMC
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: University of HohenheimUniversity, hospital or other
Collaborators: Universität Tübingen
Study start: 22 Jun 2017 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 1 Jul 2018 (actual)
First posted: 18 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Dietary Supplement: PlaceboMannitol and silicon dioxide
Native 6-prenylnaringenin	Experimental	Dietary Supplement: Native 6-prenylnaringenin250 mg native 6-PN plus mannitol and silicon dioxide
Micellar 6-prenylnaringenin	Experimental	Dietary Supplement: Micellar 6-prenylnaringenin250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy volunteers with blood chemistry values within normal ranges
Age: 18-45 years
BMI: 19-25 kg/m2

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboMannitol and silicon dioxide capsules	Dietary supplement	Placebo
Native 6-prenylnaringenin250 mg native 6-PN plus mannitol and silicon dioxide capsules	Dietary supplement	Native 6-prenylnaringenin
Micellar 6-prenylnaringenin250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant capsules	Dietary supplement	Micellar 6-prenylnaringenin

Primary outcome

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
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
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
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
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
Cell viability of PBMCs after 6-PN administration
Time frame: 0 h, 6 h, and 24 h post dose

22 secondary outcomes

Serum aspartate transaminase activity [U/L]
Time frame: 0 h, 4 h, 24h post-dose
Serum alanine transaminase activity [U/L]
Time frame: 0 h, 4 h, 24h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Time frame: 0 h, 4 h, 24h post-dose
Serum alkaline phosphatase activity [U/L]
Time frame: 0 h, 4 h, 24h post-dose
Serum bilirubin
Time frame: 0 h, 4 h, 24h post-dose
Serum uric acid [mg/dL]
Time frame: 0 h, 4 h, 24h post-dose
Serum creatinine [mg/dL]
Time frame: 0 h, 4 h, 24h post-dose
Serum total cholesterol [mg/dL]
Time frame: 0 h, 4 h, 24h post-dose
Serum HDL cholesterol [mg/dL]
Time frame: 0 h, 4 h, 24h post-dose
Serum LDL cholesterol [mg/dL]
Time frame: 0 h, 4 h, 24h post-dose
Serum triacylglycerols [mg/dL]
Time frame: 0 h, 4 h, 24h post-dose
LDL/HDL cholesterol ratio
Time frame: 0 h, 4 h, 24h post-dose
Glomerular filtration rate [mL/min]
Time frame: 0 h, 4 h, 24h post-dose
Serum glucose [mg/dL]
Time frame: 0 h, 4 h, 24h post-dose
Hemoglobin [g/dL]
Time frame: 0 h, 24 h post-dose
Mean corpuscular hemoglobin concentration [g/dL]
Time frame: 0 h, 24 h post-dose
Mean corpuscular hemoglobin [pg]
Time frame: 0 h, 24 h post-dose
Mean corpuscular volume [fL]
Time frame: 0 h, 24 h post-dose
Hematocrit [%]
Time frame: 0 h, 24 h post-dose
Erythrocytes [/pL]
Time frame: 0 h, 24 h post-dose
Thrombocytes [/nL]
Time frame: 0 h, 24 h post-dose
Leucocytes [/nL]
Time frame: 0 h, 24 h post-dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
Website of the research groupLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jan Frank, Prof. Dr. principal investigator

University of Hohenheim

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

University Hospital, Eberhard Karls University Tuebingen, Germany

Christian Busch, Dr. med. principal investigator

University Hospital, Eberhard Karls University Tuebingen, Germany

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03286777.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.