Clinical trial NCT05711212: Effects of Xanthohumol on Resting Energy Expenditure and Substrate Oxidation in Healthy Women
Official title: Effects of Micellar Solubilized Xanthohumol on Resting Energy Expenditure and Substrate Oxidation in Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resting Energy Expenditure
Keywords: Xanthohumol
micellar solubilization
fatty acid oxidation
Lead sponsor: University of Bonn
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute Effect on Resting Energy Expenditure
timeFrame: assessed uninterrupted for 3 hours post dose
measure: Prolonged Effect on Resting Energy Expenditure
timeFrame: assessed uninterrupted for 30 minutes 24 h post dose
measure: Acute Effect on Substrate Oxidation
timeFrame: assessed uninterrupted for 3 hours post dose
measure: Prolonged Effect on Substrate Oxidation
timeFrame: assessed uninterrupted for 30 minutes 24 h post dose
Secondary outcomes:
measure: Acute Effect on Blood pressure
timeFrame: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180 minutes post dose
measure: Prolonged Effect on Blood pressure
timeFrame: 24 hours, 24 hours and 10 minutes, 24 hours and 20 minutes, 24 hours and 30 minutes post dose
measure: Acute Effect on Pulse
timeFrame: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180 minutes post dose
measure: Prolonged Effect on Pulse
timeFrame: 24 hours, 24 hours and 10 minutes, 24 hours and 20 minutes, 24 hours and 30 minutes post dose
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn
Study officials:
affiliation: University of Bonn
name: Sarah Egert, Prof PhD
role: PRINCIPAL_INVESTIGATOR
References: