Oral Bioavailability and Bioactivity of Prenylflavonoids From Hops

University of Hohenheim

Status and phase: Completed; Early Phase 1

Conditions: Safety After Oral Intake; Immune Cells Activity; Pharmacokinetics After Oral Intake

Treatments: Dietary Supplement: 6-prenylnaringenin; Dietary Supplement: Placebo; Dietary Supplement: 8-prenylnaringenin

Study type: Interventional

Funder types: Other

Identifiers

NCT03140397

HS-PF1-2016

Details and patient eligibility

About

The prenylflavonoids 6-prenylnaringenin (6-PN) and 8-prenylnaringenin (8-PN) are secondary plant substances, almost exclusively found in hops (Humulus lupulus). Both compounds have known potential biological properties, but poor bioavailability due to their low oral absorption and retention. Our study followed a single dose (500 mg 6- or 8-PN), placebo controlled, randomized, double-blind, three armed crossover study design with ≥2-week washout periods. Plasma, PBMC and urine samples were collected at intervals up to 24 h after intake. Investigators investigated the safety, pharmacokinetics and impact of oral prenylflavonoids on the function of cells of the immune system.

Enrollment: 16 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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16 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Capsules filled with mannitol and silicon dioxide

Treatment:

Dietary Supplement: Placebo

6-prenylnaringenin

Experimental group

Description:

500 mg 6-PN plus mannitol and silicon dioxide

Treatment:

Dietary Supplement: 6-prenylnaringenin

8-prenylnaringenin

Experimental group

Description:

500 mg 8-PN plus mannitol and silicon dioxide

Treatment:

Dietary Supplement: 8-prenylnaringenin