University of Bonn
Bonn, 53115, Germany
Completed
NCT Number: NCT05524714
Plasma Appearance of Xanthohumol in Healthy Adults
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.
Completed
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Conditions
Age range
18 year–35 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
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
- veganism or unbalanced diets
- use of medication
- pregnancy or lactating
- participation in another intervention study
Treatment and study plan
solubilized Xanthohumol low dose
Dietary Supplementsingle administration of 2 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol and 2 soft gelatine capsules containing only micelles
solubilized Xanthohumol high dose
Dietary Supplementsingle administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol
native Xanthohumol low dose
Dietary Supplementsingle administration of 2 hard gelatine capsules each containing 43 mg native Xanthohumol and 2 hard gelatine capsules containing silicon dioxide
native Xanthohumol high dose
Dietary Supplementsingle administration of 4 hard gelatine capsules each containing 43 mg native Xanthohumol
Primary outcomes
-
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 (%)
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
Mean area under the curve (AUC) of plasma concentration vs. time of Xanthohumol glucuronides (nmol/L*h)
-
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
Mean area under the curve (AUC) of plasma concentration vs. time of Xanthohumol sulfates (nmol/L*h)
-
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
Mean area under the curve (AUC) of plasma concentration vs. time of free Xanthohumol (nmol/L*h)
-
Cmax Xanthohumol glucuronides
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 Xanthohumol glucuronides (nmol/L)
-
Cmax Xanthohumol sulfates
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 Xanthohumol sulfates (nmol/L)
-
Cmax free 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 free Xanthohumol (nmol/L)
-
tmax Xanthohumol glucuronides
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 Xanthohumol glucuronides [h]
-
tmax Xanthohumol sulfates
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 Xanthohumol sulfates [h]
-
tmax free 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 free Xanthohumol [h]
Sponsors and collaborators
Lead sponsor
University of Bonn
Other
Collaborators
- University of Hohenheim
Registry information
Official study title
Plasmakinetics of Micellar Solubilized Xanthohumol in Metabolically Healthy Men and Women
Important dates
- Study start
- 2022
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Sep 1, 2022
- Registry last updated
- Nov 22, 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.