Plasmakinetics of XanthohumolNCT05524714
Plasma Appearance of Xanthohumol in Healthy Adults
A study testing solubilized Xanthohumol low dose, solubilized Xanthohumol high dose and native Xanthohumol low dose in people with Plasmakinetics of Xanthohumol, run by University of Bonn at 1 site in Germany.
Trial summary
The aim of this study is to investigate the rate and extend of the plasma appearance of native Xanthohumol and Xanthohumol integrated into micelles in healthy men and women. Therefore, participants consume capsules with either 86 or 172 mg of native Xanthohumol or Xanthohumol integrated into micelles. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmakinetics of Xanthohumol
- What is being tested?
- solubilized Xanthohumol low dose, solubilized Xanthohumol high dose and native Xanthohumol low dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2022to 3 Mar 2023
- 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
- All sexes
- 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 15Show fewer
- hepatitis B or C, HIV Infection
- chronic inflammatory diseases
- disordered eating
- psychological diseases
- alcohol and/or drug abuse
- veganism or unbalanced diets
- use of medication
- pregnancy or lactating
- participation in another intervention study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasmakinetics of Micellar Solubilized Xanthohumol in Metabolically Healthy Men and Women
The aim of this study is to investigate the rate and extend of the plasma appearance of native Xanthohumol and Xanthohumol integrated into micelles in healthy men and women. Therefore, participants consume capsules with either 86 or 172 mg of native Xanthohumol or Xanthohumol integrated into micelles. In an observation period of 24 hours, Xanthohumol and its major metabolites are analyzed in plasma.
Read the detailed description
In a crossover design, 6 healthy young men and 6 healthy young women participate in 4 Xanthohumol interventions with either 86 or 172 mg native or micellar solubilized Xanthohumol. During an observation period of 24 hours, Xanthohumol and its major metabolites Isoxanthohumol, 8- and 6-Prenylnaringenin are analyzed in plasma. Each intervention will be separated by a wash-out period of 14 days. Typical plasmakinetic analyses (Cmax, tmax, AUC, t1/2, bioavailability) will be conducted.
- Conditions
- Plasmakinetics of Xanthohumol
- Being tested
- solubilized Xanthohumol low dose, solubilized Xanthohumol high dose, native Xanthohumol low dose, native Xanthohumol high dose
- Keywords
- Polyphenols, Hops, Bioavailability, Xanthohumol, Plasma Kinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solubilized Xanthohumol low doseDietary supplement
single administration of 2 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol and 2 soft gelatine capsules containing only micelles
solubilized Xanthohumol high doseDietary supplement
single administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol
native Xanthohumol low doseDietary supplement
single administration of 2 hard gelatine capsules each containing 43 mg native Xanthohumol and 2 hard gelatine capsules containing silicon dioxide
native Xanthohumol high doseDietary supplement
single administration of 4 hard gelatine capsules each containing 43 mg native Xanthohumol
| Study group | Role | What they receive |
|---|---|---|
| solubilized Xanthohumol low dose | Experimental | single dose of 86 mg micellar solubilized Xanthohumol Receives: Dietary Supplement: solubilized Xanthohumol low dose |
| solubilized Xanthohumol high dose | Experimental | single dose of 172 mg micellar solubilized Xanthohumol Receives: Dietary Supplement: solubilized Xanthohumol high dose |
| native Xanthohumol low dose | Active comparator | single dose of 86 mg native Xanthohumol Receives: Dietary Supplement: native Xanthohumol low dose |
| native Xanthohumol high dose | Active comparator | single dose of 172 mg native Xanthohumol Receives: Dietary Supplement: native Xanthohumol high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic exposure to Xanthohumol
Mean area under the curve (AUC) of plasma concentration vs. time of total Xanthohumol (nmol/L*h)
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Cmax Xanthohumol
Mean maximum plasma concentration of total Xanthohumol (nmol/L)
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
tmax Xanthohumol
Time to reach maximum plasma concentration of total Xanthohumol [h]
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Oral bioavailability Xanthohumol
Minimum bioavailable amount of the ingested compound (%)
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Secondary outcomes (9)
Systemic exposure to Xanthohumol glucuronides
Mean area under the curve (AUC) of plasma concentration vs. time of Xanthohumol glucuronides (nmol/L*h)
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Systemic exposure to Xanthohumol sulfates
Mean area under the curve (AUC) of plasma concentration vs. time of Xanthohumol sulfates (nmol/L*h)
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Systemic exposure to free Xanthohumol
Mean area under the curve (AUC) of plasma concentration vs. time of free Xanthohumol (nmol/L*h)
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Cmax Xanthohumol glucuronides
Mean maximum plasma concentration of Xanthohumol glucuronides (nmol/L)
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Cmax Xanthohumol sulfates
Mean maximum plasma concentration of Xanthohumol sulfates (nmol/L)
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Cmax free Xanthohumol
Mean maximum plasma concentration of free Xanthohumol (nmol/L)
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
tmax Xanthohumol glucuronides
Time to reach maximum plasma concentration of Xanthohumol glucuronides [h]
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
tmax Xanthohumol sulfates
Time to reach maximum plasma concentration of Xanthohumol sulfates [h]
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
tmax free Xanthohumol
Time to reach maximum plasma concentration of free Xanthohumol [h]
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Aug 2022
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
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 Plasmakinetics of XanthohumolStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hohenheim
- 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
- NCT05524714
- Sponsor's protocol ID
- XN BV
- Status last verified
- Nov 2024
- First submitted
- 15 Aug 2022
- Last updated
- 22 Nov 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 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasmakinetics of Micellar Solubilized Xanthohumol in Metabolically Healthy Men and Women
- ClinicalTrials.gov ID
- NCT05524714
- Acronym / sponsor ID
- XN BV
- Conditions
- Plasmakinetics of Xanthohumol
- Keywords
- Polyphenols, Hops, Bioavailability, Xanthohumol, Plasma Kinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Collaborators
- University of Hohenheim
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 1 Sep 2022 (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 rate and extend of the plasma appearance of native Xanthohumol and Xanthohumol integrated into micelles in healthy men and women. Therefore, participants consume capsules with either 86 or 172 mg of native Xanthohumol or Xanthohumol integrated into micelles. In an observation period of 24 hours, Xanthohumol and its major metabolites are analyzed in plasma.
Detailed description
In a crossover design, 6 healthy young men and 6 healthy young women participate in 4 Xanthohumol interventions with either 86 or 172 mg native or micellar solubilized Xanthohumol. During an observation period of 24 hours, Xanthohumol and its major metabolites Isoxanthohumol, 8- and 6-Prenylnaringenin are analyzed in plasma. Each intervention will be separated by a wash-out period of 14 days. Typical plasmakinetic analyses (Cmax, tmax, AUC, t1/2, bioavailability) will be conducted.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| solubilized Xanthohumol low dose | Experimental | Dietary Supplement: solubilized Xanthohumol low dosesingle dose of 86 mg micellar solubilized Xanthohumol |
| solubilized Xanthohumol high dose | Experimental | Dietary Supplement: solubilized Xanthohumol high dosesingle dose of 172 mg micellar solubilized Xanthohumol |
| native Xanthohumol low dose | Active comparator | Dietary Supplement: native Xanthohumol low dosesingle dose of 86 mg native Xanthohumol |
| native Xanthohumol high dose | Active comparator | Dietary Supplement: native Xanthohumol high dosesingle dose of 172 mg native Xanthohumol |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- 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 (15 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 |
|---|---|---|
| solubilized Xanthohumol low dosesingle administration of 2 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol and 2 soft gelatine capsules containing only micelles | Dietary supplement | solubilized Xanthohumol low dose |
| solubilized Xanthohumol high dosesingle administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol | Dietary supplement | solubilized Xanthohumol high dose |
| native Xanthohumol low dosesingle administration of 2 hard gelatine capsules each containing 43 mg native Xanthohumol and 2 hard gelatine capsules containing silicon dioxide | Dietary supplement | native Xanthohumol low dose |
| native Xanthohumol high dosesingle administration of 4 hard gelatine capsules each containing 43 mg native Xanthohumol | Dietary supplement | native Xanthohumol high dose |
Primary outcome
Systemic exposure to Xanthohumol
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Mean area under the curve (AUC) of plasma concentration vs. time of total Xanthohumol (nmol/L*h)
Cmax Xanthohumol
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Mean maximum plasma concentration of total Xanthohumol (nmol/L)
tmax Xanthohumol
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Time to reach maximum plasma concentration of total Xanthohumol [h]
Oral bioavailability Xanthohumol
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Minimum bioavailable amount of the ingested compound (%)
9 secondary outcomes
Systemic exposure to Xanthohumol glucuronides
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Systemic exposure to Xanthohumol sulfates
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Systemic exposure to free Xanthohumol
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Cmax Xanthohumol glucuronides
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Cmax Xanthohumol sulfates
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
Cmax free Xanthohumol
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
tmax Xanthohumol glucuronides
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
tmax Xanthohumol sulfates
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
tmax free Xanthohumol
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours 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 22 Nov 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
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 solubilized Xanthohumol low dose, solubilized Xanthohumol high dose and native Xanthohumol low dose in people with Plasmakinetics of Xanthohumol, 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 15 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 22 Nov 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. 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?
Systemic exposure to Xanthohumol (time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 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 NCT05524714, 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 22 Nov 2024.