Plasma Appearance of Xanthohumol in Healthy Adults

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 high dose; Dietary Supplement: native Xanthohumol low 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

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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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