Plasma Appearance of Xanthohumol in Healthy Adults

Not Applicable

Completed

• Conditions: Plasmakinetics of Xanthohumol
• Interventions: Dietary Supplement: native Xanthohumol high dose; Dietary Supplement: solubilized Xanthohumol high dose; Dietary Supplement: solubilized Xanthohumol low dose; Dietary Supplement: native Xanthohumol low dose

• Registration Number: NCT05524714
• Lead Sponsor: University of Bonn

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.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-01
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• BMI: 18,5 - 24,9 kg/m2
• metabolically healthy
• written consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
native Xanthohumol high dose	native Xanthohumol high dose	single dose of 172 mg native Xanthohumol
solubilized Xanthohumol high dose	solubilized Xanthohumol high dose	single dose of 172 mg micellar solubilized Xanthohumol
solubilized Xanthohumol low dose	solubilized Xanthohumol low dose	single dose of 86 mg micellar solubilized Xanthohumol
native Xanthohumol low dose	native Xanthohumol low dose	single dose of 86 mg native Xanthohumol

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
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)
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 \[h\]

Trial Locations

Locations (1)

University of Bonn; 🇩🇪 Bonn, Germany