Resting Energy ExpenditureNCT05711212
Effects of Xanthohumol on Resting Energy Expenditure and Substrate Oxidation in Healthy Women
A study testing micellar solubilized Xanthohumol in people with Resting Energy Expenditure, run by University of Bonn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Resting Energy Expenditure
- What is being tested?
- micellar solubilized Xanthohumol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 15 Feb 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 18,5 - 24,9 kg/m2
- metabolically healthy
- written consent
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Resting Energy Expenditure
- Being tested
- micellar solubilized Xanthohumol, Placebo
- Keywords
- Xanthohumol, micellar solubilization, fatty acid oxidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micellar solubilized XanthohumolDietary supplement
single administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol
PlaceboDietary supplement
single administration of 4 soft gelatine capsules containing only micelles
| Study group | Role | What they receive |
|---|---|---|
| Xanthohumol | Experimental | single dose of 172 mg of micellar solubilized Xanthohumol Receives: Dietary Supplement: micellar solubilized Xanthohumol |
| Placebo | Placebo comparator | Polysorbat 80 (E433) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: assessed uninterrupted for 3 hours post dose
Prolonged Effect on Substrate Oxidation
assessed by the respiratory quotient (RQ=VCO2/VO2), given in percent
Measured: assessed uninterrupted for 30 minutes 24 h post dose
Secondary outcomes (4)
Acute Effect on Blood pressure
given in millimeter mercury
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours, 24 hours and 10 minutes, 24 hours and 20 minutes, 24 hours and 30 minutes post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start15 Feb 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resting Energy ExpenditureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Sarah Egert, University of Bonn
- Investigators
- Sarah Egert, Prof PhD, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711212
- Sponsor's protocol ID
- XN REE
- Status last verified
- May 2024
- First submitted
- 24 Jan 2023
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brehmer-Henkel S, Diekmann C, Eickeler M, Maris R, Kopp C, Coenen M, Nemeth R, Stoffel-Wagner B, Sus N, Frank J, Egert S. The Bioavailability of Xanthohumol in Humans and the Influence of Formulation and Dose: Randomized Controlled Trial Data. Mol Nutr Food Res. 2026 Feb;70(4):e70413. doi: 10.1002/mnfr.70413.
PubMed 41723719
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Micellar Solubilized Xanthohumol on Resting Energy Expenditure and Substrate Oxidation in Healthy Women
- ClinicalTrials.gov ID
- NCT05711212
- Acronym / sponsor ID
- XN REE
- Conditions
- Resting Energy Expenditure
- Keywords
- Xanthohumol, micellar solubilization, fatty acid oxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xanthohumol | Experimental | Dietary Supplement: micellar solubilized Xanthohumolsingle dose of 172 mg of micellar solubilized Xanthohumol |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPolysorbat 80 (E433) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI: 18,5 - 24,9 kg/m2
- metabolically healthy
- written consent
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micellar solubilized Xanthohumolsingle administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol | Dietary supplement | Xanthohumol |
| Placebosingle administration of 4 soft gelatine capsules containing only micelles | Dietary supplement | Placebo |
Primary outcome
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
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
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
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Derived from this study: PubMed 41723719Brehmer-Henkel S, Diekmann C, Eickeler M, Maris R, Kopp C, Coenen M, Nemeth R, Stoffel-Wagner B, Sus N, Frank J, Egert S. The Bioavailability of Xanthohumol in Humans and the Influence of Formulation and Dose: Randomized Controlled Trial Data. Mol Nutr Food Res. 2026 Feb;70(4):e70413. doi: 10.1002/mnfr.70413.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Egert, Prof PhD principal investigator
University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micellar solubilized Xanthohumol in people with Resting Energy Expenditure, run by University of Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Effect on Resting Energy Expenditure (time frame: assessed uninterrupted for 3 hours post dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05711212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.