Plasma Appearance of Xanthohumol in Healthy Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Plasmakinetics of Micellar Solubilized Xanthohumol in Metabolically Healthy Men and Women

Conditions
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Plasmakinetics of Xanthohumol

Intervention / Treatment
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* Dietary Supplement: solubilized Xanthohumol low dose
* Dietary Supplement: solubilized Xanthohumol high dose
* Dietary Supplement: native Xanthohumol low dose
* Dietary Supplement: native Xanthohumol high dose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: solubilized Xanthohumol low dose<br>single dose of 86 mg micellar solubilized Xanthohumol | Dietary Supplement: solubilized Xanthohumol low dose<br>* single administration of 2 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol and 2 soft gelatine capsules containing only micelles<br>|
| Experimental: solubilized Xanthohumol high dose<br>single dose of 172 mg micellar solubilized Xanthohumol | Dietary Supplement: solubilized Xanthohumol high dose<br>* single administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol<br>|
| Active Comparator: native Xanthohumol low dose<br>single dose of 86 mg native Xanthohumol | Dietary Supplement: native Xanthohumol low dose<br>* single administration of 2 hard gelatine capsules each containing 43 mg native Xanthohumol and 2 hard gelatine capsules containing silicon dioxide<br>|
| Active Comparator: native Xanthohumol high dose<br>single dose of 172 mg native Xanthohumol | Dietary Supplement: native Xanthohumol high dose<br>* single administration of 4 hard gelatine capsules each containing 43 mg native Xanthohumol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic exposure to Xanthohumol | Mean area under the curve (AUC) of plasma concentration vs. time of total Xanthohumol (nmol/L*h) | 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) | 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] | 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 (%) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic exposure to Isoxanthohumol | Mean area under the curve (AUC) of plasma concentration vs. time of total Isoxanthohumol (nmol/L*h) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose | 
| Systemic exposure to 8-Prenylnaringenin | Mean area under the curve (AUC) of plasma concentration vs. time of total 8-Prenylnaringenin (nmol/L*h) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose | 
| Systemic exposure to 6-Prenylnaringenin | Mean area under the curve (AUC) of plasma concentration vs. time of total 6-Prenylnaringenin (nmol/L*h) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose | 
| Cmax Isoxanthohumol | Mean maximum plasma concentration of total Isoxanthohumol (nmol/L) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose | 
| Cmax 8-Prenylnaringenin | Mean maximum plasma concentration of total 8-Prenylnaringenin (nmol/L) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose | 
| Cmax 6-Prenylnaringenin | Mean maximum plasma concentration of total 6-Prenylnaringenin (nmol/L) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose | 
| tmax Isoxanthohumol | Time to reach maximum plasma concentration of total Isoxanthohumol [h] | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose | 
| tmax 8-Prenylnaringenin | Time to reach maximum plasma concentration of total 8-Prenylnaringenin [h] | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose | 
| tmax 6-Prenylnaringenin | Time to reach maximum plasma concentration of total 6-Prenylnaringenin [h] | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9 and 24 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Isoxanthohumol, 6-Prenylnaringenin, 8-Prenylnaringenin, Polyphenols, Hops, Bioavailability