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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
12
single administration of 2 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol and 2 soft gelatine capsules containing only micelles
single administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol
single administration of 2 hard gelatine capsules each containing 43 mg native Xanthohumol and 2 hard gelatine capsules containing silicon dioxide
University of Bonn
Bonn, Germany
Systemic exposure to Xanthohumol
Mean area under the curve (AUC) of plasma concentration vs. time of total Xanthohumol (nmol/L\*h)
Time frame: 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)
Time frame: 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 \[h\]
Time frame: 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 (%)
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 glucuronides
Mean area under the curve (AUC) of plasma concentration vs. time of Xanthohumol glucuronides (nmol/L\*h)
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
Mean area under the curve (AUC) of plasma concentration vs. time of Xanthohumol sulfates (nmol/L\*h)
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
Mean area under the curve (AUC) of plasma concentration vs. time of free Xanthohumol (nmol/L\*h)
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose
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single administration of 4 hard gelatine capsules each containing 43 mg native Xanthohumol
Cmax Xanthohumol glucuronides
Mean maximum plasma concentration of Xanthohumol glucuronides (nmol/L)
Time frame: 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)
Time frame: 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)
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 to reach maximum plasma concentration of Xanthohumol glucuronides \[h\]
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 to reach maximum plasma concentration of Xanthohumol sulfates \[h\]
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 to reach maximum plasma concentration of free Xanthohumol \[h\]
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose