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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Resting Energy Expenditure
• Intervention / Treatment: Dietary supplement: micellar solubilized Xanthohumol; Dietary supplement: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany, 53115
    • Recruiting
    • University of Bonn
    • Contact: Sarah Egert, Prof. Dr.; Phone Number: +49(0)228/735953; Email: s.egert@uni-bonn.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; single administration of 4 soft gelatine capsules containing only micelles
Experimental: Xanthohumol; single dose of 172 mg of micellar solubilized Xanthohumol	Dietary supplement: micellar solubilized Xanthohumol; single administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Acute Effect on Substrate Oxidation	assessed by the respiratory quotient (RQ=VCO2/VO2), given in percent	assessed uninterrupted for 3 hours post dose
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Bonn

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Xanthohumol; fatty acid oxidation; micellar solubilization
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Xanthohumol
• Other Study ID Numbers: XN REE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No