Clinical trial NCT03286777: Increasing the Oral Bioavailability of 6-prenylnaringenin by Micellar Solubilization
Official title: Increasing the Oral Bioavailability of 6-prenylnaringenin by Micellar Solubilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
Collaborators: name: Universität Tübingen
First posted: 2017-09-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean area under the curve (AUC) of plasma concentration vs. time of total 6-PN [nmol/L*h]
timeFrame: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose
measure: Mean maximum plasma concentration (Cmax) of total 6-PN [nmol/L]
timeFrame: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose
measure: Time to reach maximum plasma concentration (Tmax) of total 6-PN [h]
timeFrame: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose
measure: Cumulative urinary excretion of total 6-PN [nmol/g creatinine]
timeFrame: 0 h - 24 h post dose
measure: Cell count (dead cells/ml and living cells/ml) of PBMCs after 6-PN administration
timeFrame: 0 h, 6 h, and 24 h post dose
measure: Cell viability of PBMCs after 6-PN administration
timeFrame: 0 h, 6 h, and 24 h post dose
Secondary outcomes:
measure: Serum aspartate transaminase activity [U/L]
timeFrame: 0 h, 4 h, 24h post-dose
measure: Serum alanine transaminase activity [U/L]
timeFrame: 0 h, 4 h, 24h post-dose
measure: Serum gamma-glutamyl transferase activity [U/L]
timeFrame: 0 h, 4 h, 24h post-dose
measure: Serum alkaline phosphatase activity [U/L]
timeFrame: 0 h, 4 h, 24h post-dose
measure: Serum bilirubin
timeFrame: 0 h, 4 h, 24h post-dose
measure: Serum uric acid [mg/dL]
timeFrame: 0 h, 4 h, 24h post-dose
measure: Serum creatinine [mg/dL]
timeFrame: 0 h, 4 h, 24h post-dose
measure: Serum total cholesterol [mg/dL]
timeFrame: 0 h, 4 h, 24h post-dose
measure: Serum HDL cholesterol [mg/dL]
timeFrame: 0 h, 4 h, 24h post-dose
measure: Serum LDL cholesterol [mg/dL]
timeFrame: 0 h, 4 h, 24h post-dose
measure: Serum triacylglycerols [mg/dL]
timeFrame: 0 h, 4 h, 24h post-dose
measure: LDL/HDL cholesterol ratio
timeFrame: 0 h, 4 h, 24h post-dose
measure: Glomerular filtration rate [mL/min]
timeFrame: 0 h, 4 h, 24h post-dose
measure: Serum glucose [mg/dL]
timeFrame: 0 h, 4 h, 24h post-dose
measure: Hemoglobin [g/dL]
timeFrame: 0 h, 24 h post-dose
measure: Mean corpuscular hemoglobin concentration [g/dL]
timeFrame: 0 h, 24 h post-dose
measure: Mean corpuscular hemoglobin [pg]
timeFrame: 0 h, 24 h post-dose
measure: Mean corpuscular volume [fL]
timeFrame: 0 h, 24 h post-dose
measure: Hematocrit [%]
timeFrame: 0 h, 24 h post-dose
measure: Erythrocytes [/pL]
timeFrame: 0 h, 24 h post-dose
measure: Thrombocytes [/nL]
timeFrame: 0 h, 24 h post-dose
measure: Leucocytes [/nL]
timeFrame: 0 h, 24 h post-dose
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Eberhard Karls University Tuebingen
state: Baden-Württemberg
Study officials:
affiliation: University of Hohenheim
name: Jan Frank, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Eberhard Karls University Tuebingen, Germany
name: Sascha Venturelli, Dr. med. Dr. rer. nat.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Eberhard Karls University Tuebingen, Germany
name: Christian Busch, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: