Plasmakinetics of Xanthohumol
Conditions
Keywords
Polyphenols, Hops, Bioavailability, Xanthohumol, Plasma Kinetics
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTsolubilized Xanthohumol low dose
single administration of 2 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol and 2 soft gelatine capsules containing only micelles
DIETARY_SUPPLEMENTsolubilized Xanthohumol high dose
single administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol
DIETARY_SUPPLEMENTnative Xanthohumol low dose
single administration of 2 hard gelatine capsules each containing 43 mg native Xanthohumol and 2 hard gelatine capsules containing silicon dioxide
DIETARY_SUPPLEMENTnative Xanthohumol high dose
single administration of 4 hard gelatine capsules each containing 43 mg native Xanthohumol
Sponsors
University of Hohenheim
University of Bonn
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systemic exposure to Xanthohumol | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Cmax Xanthohumol glucuronides | 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 | 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) |
| tmax Xanthohumol glucuronides | 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 | 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 | 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 \[h\] |
| Cmax free Xanthohumol | 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) |
| Systemic exposure to Xanthohumol glucuronides | 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 | 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 | 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) |
Countries
Germany
Outcome results
None listed