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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Resting Energy Expenditure

Intervention / Treatment
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* Dietary Supplement: micellar solubilized Xanthohumol
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xanthohumol<br>single dose of 172 mg of micellar solubilized Xanthohumol | Dietary Supplement: micellar solubilized Xanthohumol<br>* single administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* single administration of 4 soft gelatine capsules containing only micelles<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xanthohumol, micellar solubilization, fatty acid oxidation