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Plasma Appearance of Xanthohumol in Healthy Adults

NCT ID: NCT05524714

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-03-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Plasmakinetics of Xanthohumol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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solubilized Xanthohumol low dose

single dose of 86 mg micellar solubilized Xanthohumol

Group Type EXPERIMENTAL

solubilized Xanthohumol low dose

Intervention Type DIETARY_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 high dose

single dose of 172 mg micellar solubilized Xanthohumol

Group Type EXPERIMENTAL

solubilized Xanthohumol high dose

Intervention Type DIETARY_SUPPLEMENT

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

native Xanthohumol low dose

single dose of 86 mg native Xanthohumol

Group Type ACTIVE_COMPARATOR

native Xanthohumol low dose

Intervention Type DIETARY_SUPPLEMENT

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

native Xanthohumol high dose

single dose of 172 mg native Xanthohumol

Group Type ACTIVE_COMPARATOR

native Xanthohumol high dose

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

solubilized Xanthohumol high dose

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

native Xanthohumol high dose

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Hohenheim

OTHER

Sponsor Role collaborator

University of Bonn

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Sarah Egert

Prof. PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Egert, Prof PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bonn

Locations

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University of Bonn

Bonn, , Germany

Site Status

Countries

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Germany

Other Identifiers

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XN BV

Identifier Type: -

Identifier Source: org_study_id

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