Effects of Xanthohumol on Resting Energy Expenditure and Substrate Oxidation in Healthy Women

NCT ID: NCT05711212

Last Updated: 2024-05-28

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2024-04-30

Brief Summary

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The aim of this study is to investigate the effects of Xanthohumol on resting energy expenditure and substrate oxidation in healthy women. It is assumed that resting energy expenditure and fatty acid oxidation is higher after Xanthohumol ingestion.

Detailed Description

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In a crossover design, 16 healthy young women ingest 172 mg micellar solubilized Xanthohumol or placebo in a randomized fashion. During an observational period of 3 hours, the acute effects of Xanthohumol on the resting energy expenditure and substrate oxidation is determined by respiratory gas analysis. An additional 30-minute determination of the resting energy expenditure and substrate oxidation is executed 24 hours after Xanthohumol ingestion. The wash-out period will be 28 days.

Conditions

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Resting Energy Expenditure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Xanthohumol

single dose of 172 mg of micellar solubilized Xanthohumol

Group Type EXPERIMENTAL

micellar solubilized Xanthohumol

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Polysorbat 80 (E433)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

single administration of 4 soft gelatine capsules containing only micelles

Interventions

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micellar solubilized Xanthohumol

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

single administration of 4 soft gelatine capsules containing only micelles

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
* use of medication
* pregnancy or lactating
* participation in another intervention study
* irregular menstrual cycle
* more than 6 hours of sports per week
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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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 REE

Identifier Type: -

Identifier Source: org_study_id

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