NCT05524714

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

August 1, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

August 15, 2022

Last Update Submit

November 19, 2024

Conditions

Plasmakinetics of Xanthohumol

Keywords

PolyphenolsHopsBioavailabilityXanthohumolPlasma Kinetics

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (9)

  • Systemic exposure to Xanthohumol glucuronides

    0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose

  • Systemic exposure to Xanthohumol sulfates

    0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose

  • Systemic exposure to free Xanthohumol

    0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose

  • Cmax Xanthohumol glucuronides

    0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose

  • Cmax Xanthohumol sulfates

    0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose

  • +4 more secondary outcomes

Study Arms (4)

solubilized Xanthohumol low dose

EXPERIMENTAL

single dose of 86 mg micellar solubilized Xanthohumol

Dietary Supplement: solubilized Xanthohumol low dose

solubilized Xanthohumol high dose

EXPERIMENTAL

single dose of 172 mg micellar solubilized Xanthohumol

Dietary Supplement: solubilized Xanthohumol high dose

native Xanthohumol low dose

ACTIVE COMPARATOR

single dose of 86 mg native Xanthohumol

Dietary Supplement: native Xanthohumol low dose

native Xanthohumol high dose

ACTIVE COMPARATOR

single dose of 172 mg native Xanthohumol

Dietary Supplement: native Xanthohumol high dose

Interventions

solubilized Xanthohumol low doseDIETARY_SUPPLEMENT

single administration of 2 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol and 2 soft gelatine capsules containing only micelles

solubilized Xanthohumol low dose
solubilized Xanthohumol high doseDIETARY_SUPPLEMENT

single administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol

solubilized Xanthohumol high dose
native Xanthohumol low doseDIETARY_SUPPLEMENT

single administration of 2 hard gelatine capsules each containing 43 mg native Xanthohumol and 2 hard gelatine capsules containing silicon dioxide

native Xanthohumol low dose
native Xanthohumol high doseDIETARY_SUPPLEMENT

single administration of 4 hard gelatine capsules each containing 43 mg native Xanthohumol

native Xanthohumol high dose

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bonn

Bonn, 53115, Germany

Location

Study Officials

  • Sarah Egert, Prof PhD

    University of Bonn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. PhD

Study Record Dates

First Submitted

August 15, 2022

First Posted

September 1, 2022

Study Start

August 1, 2022

Primary Completion

March 3, 2023

Study Completion

March 3, 2023

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)