Increasing the Oral Bioavailability of 6-prenylnaringenin by Micellar Solubilization

University of Hohenheim

Status: Completed

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

Treatments: Dietary Supplement: Native 6-prenylnaringenin; Dietary Supplement: Micellar 6-prenylnaringenin; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03286777

HS-PF2-2017

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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6 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Mannitol and silicon dioxide

Treatment:

Dietary Supplement: Placebo

Native 6-prenylnaringenin

Experimental group

Description:

250 mg native 6-PN plus mannitol and silicon dioxide

Treatment:

Dietary Supplement: Native 6-prenylnaringenin

Micellar 6-prenylnaringenin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Micellar 6-prenylnaringenin