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Completed

NCT Number: NCT05711212

Effects of 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.

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Key information

Conditions

Resting Energy Expenditure

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Bonn

Bonn, 53115, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

micellar solubilized Xanthohumol

Dietary Supplement

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

Placebo

Dietary Supplement

single administration of 4 soft gelatine capsules containing only micelles

Primary outcomes

  1. Acute Effect on Resting Energy Expenditure

    Time frame: assessed uninterrupted for 3 hours post dose

    calculated from Volume of inhaled oxygen (VO2) in L/min and exhaled carbon dioxide (VCO2) in L/min, given in kcal/24 hours

  2. Prolonged Effect on Resting Energy Expenditure

    Time frame: assessed uninterrupted for 30 minutes 24 h post dose

    calculated from Volume of inhaled oxygen (VO2) in L/min and exhaled carbon dioxide (VCO2) in L/min, given in kcal/24hours

  3. Acute Effect on Substrate Oxidation

    Time frame: assessed uninterrupted for 3 hours post dose

    assessed by the respiratory quotient (RQ=VCO2/VO2), given in percent

  4. Prolonged Effect on Substrate Oxidation

    Time frame: assessed uninterrupted for 30 minutes 24 h post dose

    assessed by the respiratory quotient (RQ=VCO2/VO2), given in percent

Secondary outcomes

  1. Acute Effect on Blood pressure

    Time frame: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180 minutes post dose

    given in millimeter mercury

  2. Prolonged Effect on Blood pressure

    Time frame: 24 hours, 24 hours and 10 minutes, 24 hours and 20 minutes, 24 hours and 30 minutes post dose

    given in millimeter mercury

  3. Acute Effect on Pulse

    Time frame: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180 minutes post dose

    given in beats per minute

  4. Prolonged Effect on Pulse

    Time frame: 24 hours, 24 hours and 10 minutes, 24 hours and 20 minutes, 24 hours and 30 minutes post dose

    given in beats per minute

Sponsors and collaborators

Lead sponsor

University of Bonn

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 2, 2023
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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