Plasma Appearance of Xanthohumol in Healthy Adults

U

University of Bonn

Status

Completed

Conditions

Plasmakinetics of Xanthohumol

Treatments

Dietary Supplement: solubilized Xanthohumol low dose
Dietary Supplement: solubilized Xanthohumol high dose
Dietary Supplement: native Xanthohumol low dose
Dietary Supplement: native Xanthohumol high dose

Study type

Interventional

Funder types

Other

Identifiers

NCT05524714
XN BV

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

12 participants in 4 patient groups

solubilized Xanthohumol low dose
Experimental group
Description:
single dose of 86 mg micellar solubilized Xanthohumol
Treatment:
Dietary Supplement: solubilized Xanthohumol low dose
solubilized Xanthohumol high dose
Experimental group
Description:
single dose of 172 mg micellar solubilized Xanthohumol
Treatment:
Dietary Supplement: solubilized Xanthohumol high dose
native Xanthohumol low dose
Active Comparator group
Description:
single dose of 86 mg native Xanthohumol
Treatment:
Dietary Supplement: native Xanthohumol low dose
native Xanthohumol high dose
Active Comparator group
Description:
single dose of 172 mg native Xanthohumol
Treatment:
Dietary Supplement: native Xanthohumol high dose

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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