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

Resting Energy Expenditure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05711212
• Other study ID #: XN REE
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: June 2023

Study information

• Verified date: February 2023
• Source: University of Bonn
• Contact: Sarah Egert, Prof PhD
• Phone: +49(0)228/735953
• Email: s.egert[@]uni-bonn.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In a crossover design, 6 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Resting Energy Expenditure

Intervention

Dietary Supplement:
• micellar solubilized Xanthohumol
single administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol
• Placebo
single administration of 4 soft gelatine capsules containing only micelles

Locations

Country	Name	City	State
Germany	University of Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University of Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Effect on Resting Energy Expenditure	calculated from Volume of inhaled oxygen (VO2) in L/min and exhaled carbon dioxide (VCO2) in L/min, given in kcal/24 hours	assessed uninterrupted for 3 hours post dose
Primary	Prolonged Effect on Resting Energy Expenditure	calculated from Volume of inhaled oxygen (VO2) in L/min and exhaled carbon dioxide (VCO2) in L/min, given in kcal/24hours	assessed uninterrupted for 30 minutes 24 h post dose
Primary	Acute Effect on Substrate Oxidation	assessed by the respiratory quotient (RQ=VCO2/VO2), given in percent	assessed uninterrupted for 3 hours post dose
Primary	Prolonged Effect on Substrate Oxidation	assessed by the respiratory quotient (RQ=VCO2/VO2), given in percent	assessed uninterrupted for 30 minutes 24 h post dose
Secondary	Acute Effect on Blood pressure	given in millimeter mercury	0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180 minutes post dose
Secondary	Prolonged Effect on Blood pressure	given in millimeter mercury	24 hours, 24 hours and 10 minutes, 24 hours and 20 minutes, 24 hours and 30 minutes post dose
Secondary	Acute Effect on Pulse	given in beats per minute	0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180 minutes post dose
Secondary	Prolonged Effect on Pulse	given in beats per minute	24 hours, 24 hours and 10 minutes, 24 hours and 20 minutes, 24 hours and 30 minutes post dose