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

NCT05711212 | Completed

• 1 other identifier: XN REE
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Resting Energy Expenditure

Keywords

Xanthohumol; micellar solubilization; fatty acid oxidation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Acute Effect on Blood pressure

  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

  24 hours, 24 hours and 10 minutes, 24 hours and 20 minutes, 24 hours and 30 minutes post dose

• Acute Effect on Pulse

  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

  24 hours, 24 hours and 10 minutes, 24 hours and 20 minutes, 24 hours and 30 minutes post dose

Study Arms (2)

Xanthohumol

EXPERIMENTAL

single dose of 172 mg of micellar solubilized Xanthohumol

Dietary Supplement: micellar solubilized Xanthohumol

Placebo

PLACEBO COMPARATOR

Polysorbat 80 (E433)

Dietary Supplement: Placebo

Interventions

micellar solubilized Xanthohumol DIETARY_SUPPLEMENT

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

Xanthohumol

Placebo DIETARY_SUPPLEMENT

single administration of 4 soft gelatine capsules containing only micelles

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI: 18,5 - 24,9 kg/m2
• metabolically healthy
• written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bonn: lead

Study Sites (1)

University of Bonn

Bonn, 53115, Germany

Location

Study Officials

• Sarah Egert, Prof PhD

  University of Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. PhD

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: February 15, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)