NCT05524714

Plasma Appearance of Xanthohumol in Healthy Adults

Plasmakinetics of Micellar Solubilized Xanthohumol in Metabolically Healthy Men and Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Bonn · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Plasmakinetics of Xanthohumol

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	solubilized 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_SUPPLEMENT	solubilized Xanthohumol high dose	single administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol
DIETARY_SUPPLEMENT	native 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_SUPPLEMENT	native Xanthohumol high dose	single administration of 4 hard gelatine capsules each containing 43 mg native Xanthohumol

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-03-03
• Completion: 2023-03-03
• First posted: 2022-09-01
• Last updated: 2024-11-22

Locations

1 site across 1 country: Germany