Plasma Appearance of Xanthohumol in Healthy Adults

Plasmakinetics of Micellar Solubilized Xanthohumol in Metabolically Healthy Men and Women

The aim of this study is to investigate the rate and extend of the plasma appearance of native Xanthohumol and Xanthohumol integrated into micelles in healthy men and women. Therefore, participants consume capsules with either 86 or 172 mg of native Xanthohumol or Xanthohumol integrated into micelles. In an observation period of 24 hours, Xanthohumol and its major metabolites are analyzed in plasma.

Study Overview

• Status: Completed
• Conditions: Plasmakinetics of Xanthohumol
• Intervention / Treatment: Dietary supplement: solubilized Xanthohumol low dose; Dietary supplement: solubilized Xanthohumol high dose; Dietary supplement: native Xanthohumol low dose; Dietary supplement: native Xanthohumol high dose

Detailed Description

In a crossover design, 6 healthy young men and 6 healthy young women participate in 4 Xanthohumol interventions with either 86 or 172 mg native or micellar solubilized Xanthohumol. During an observation period of 24 hours, Xanthohumol and its major metabolites Isoxanthohumol, 8- and 6-Prenylnaringenin are analyzed in plasma. Each intervention will be separated by a wash-out period of 14 days. Typical plasmakinetic analyses (Cmax, tmax, AUC, t1/2, bioavailability) will be conducted.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany, 53115
    • University of Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• BMI: 18,5 - 24,9 kg/m2
• metabolically healthy
• written consent

Exclusion Criteria:

• smoking
• low or high blood pressure
• dyslipidemia
• insulin resistance or diabetes mellitus type 1 or type 2
• gastrointestinal diseases (e.g. food intolerances or allergies)
• liver, kidney and/or thyroid diseases
• hepatitis B or C, HIV Infection
• chronic inflammatory diseases
• disordered eating
• psychological diseases
• alcohol and/or drug abuse
• veganism or unbalanced diets
• use of medication
• pregnancy or lactating
• participation in another intervention study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: solubilized Xanthohumol low dose; single dose of 86 mg micellar solubilized Xanthohumol	Dietary supplement: solubilized Xanthohumol low dose; single administration of 2 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol and 2 soft gelatine capsules containing only micelles
Experimental: solubilized Xanthohumol high dose; single dose of 172 mg micellar solubilized Xanthohumol	Dietary supplement: solubilized Xanthohumol high dose; single administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol
Active Comparator: native Xanthohumol low dose; single dose of 86 mg native Xanthohumol	Dietary supplement: native Xanthohumol low dose; single administration of 2 hard gelatine capsules each containing 43 mg native Xanthohumol and 2 hard gelatine capsules containing silicon dioxide
Active Comparator: native Xanthohumol high dose; single dose of 172 mg native Xanthohumol	Dietary supplement: native Xanthohumol high dose; single administration of 4 hard gelatine capsules each containing 43 mg native Xanthohumol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic exposure to Xanthohumol	Mean area under the curve (AUC) of plasma concentration vs. time of total Xanthohumol (nmol/L*h)	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Cmax Xanthohumol	Mean maximum plasma concentration of total Xanthohumol (nmol/L)	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
tmax Xanthohumol	Time to reach maximum plasma concentration of total Xanthohumol [h]	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Oral bioavailability Xanthohumol	Minimum bioavailable amount of the ingested compound (%)	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic exposure to Xanthohumol glucuronides	Mean area under the curve (AUC) of plasma concentration vs. time of Xanthohumol glucuronides (nmol/L*h)	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Systemic exposure to Xanthohumol sulfates	Mean area under the curve (AUC) of plasma concentration vs. time of Xanthohumol sulfates (nmol/L*h)	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Systemic exposure to free Xanthohumol	Mean area under the curve (AUC) of plasma concentration vs. time of free Xanthohumol (nmol/L*h)	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Cmax Xanthohumol glucuronides	Mean maximum plasma concentration of Xanthohumol glucuronides (nmol/L)	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Cmax Xanthohumol sulfates	Mean maximum plasma concentration of Xanthohumol sulfates (nmol/L)	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Cmax free Xanthohumol	Mean maximum plasma concentration of free Xanthohumol (nmol/L)	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
tmax Xanthohumol glucuronides	Time to reach maximum plasma concentration of Xanthohumol glucuronides [h]	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
tmax Xanthohumol sulfates	Time to reach maximum plasma concentration of Xanthohumol sulfates [h]	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
tmax free Xanthohumol	Time to reach maximum plasma concentration of free Xanthohumol [h]	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose

Collaborators and Investigators

• Sponsor: University of Bonn
• Collaborators: University of Hohenheim
• Investigators: Principal Investigator: Sarah Egert, Prof PhD, University of Bonn

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): March 3, 2023

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Bioavailability; Polyphenols; Xanthohumol; Hops; Plasma Kinetics
• Additional Relevant MeSH Terms: Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Xanthohumol
• Other Study ID Numbers: XN BV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No