NCT03286777

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

September 14, 2017

Last Update Submit

October 9, 2018

Conditions

Safety of Native vs. Micellar 6-PN After Oral IntakePharmacokinetics of Native vs. Micellar 6-PN After Oral IntakePBMC Activity After Native vs. Micellar 6-PN Oral Intake

Keywords

6-prenylnaringeninBioavailabilityPharmacokineticsPBMC

Outcome Measures

Primary Outcomes (6)

  • 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

    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

    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

    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

    0 h - 24 h post dose

  • Cell count (dead cells/ml and living cells/ml) of PBMCs after 6-PN administration

    0 h, 6 h, and 24 h post dose

  • Cell viability of PBMCs after 6-PN administration

    0 h, 6 h, and 24 h post dose

Secondary Outcomes (22)

  • Serum aspartate transaminase activity [U/L]

    0 h, 4 h, 24h post-dose

  • Serum alanine transaminase activity [U/L]

    0 h, 4 h, 24h post-dose

  • Serum gamma-glutamyl transferase activity [U/L]

    0 h, 4 h, 24h post-dose

  • Serum alkaline phosphatase activity [U/L]

    0 h, 4 h, 24h post-dose

  • Serum bilirubin

    0 h, 4 h, 24h post-dose

  • +17 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Mannitol and silicon dioxide

Dietary Supplement: Placebo

Native 6-prenylnaringenin

EXPERIMENTAL

250 mg native 6-PN plus mannitol and silicon dioxide

Dietary Supplement: Native 6-prenylnaringenin

Micellar 6-prenylnaringenin

EXPERIMENTAL

250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant

Dietary Supplement: Micellar 6-prenylnaringenin

Interventions

PlaceboDIETARY_SUPPLEMENT

Mannitol and silicon dioxide capsules

Placebo
Native 6-prenylnaringeninDIETARY_SUPPLEMENT

250 mg native 6-PN plus mannitol and silicon dioxide capsules

Native 6-prenylnaringenin
Micellar 6-prenylnaringeninDIETARY_SUPPLEMENT

250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant capsules

Micellar 6-prenylnaringenin

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Hohenheim

Stuttgart, Baden-Wurttemberg, 70599, Germany

Location

Eberhard Karls University Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Links

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 18, 2017

Study Start

June 22, 2017

Primary Completion

December 31, 2017

Study Completion

July 1, 2018

Last Updated

October 10, 2018

Record last verified: 2018-10

Locations

DE(2)