Xanthohumol and Metabolic Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine the pharmacokinetics (PK) of xanthohumol (XN). Small amounts of xanthohumol occur naturally in hops, used to make beer, and XN is also found in beer itself. Studies in animals have shown that XN can lower blood sugar and blood lipids such as triglycerides, which can contribute to heart disease. The purpose of this study is to see how much of the XN is absorbed into the blood and how fast it leaves the body when taken by mouth. Once the PK study has been done, the investigators' long-term goal is to learn if xanthohumol can lower risk factors for heart disease and type-2 diabetes in humans.

Official Title
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Xanthohumol and Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Xanthohumol


Participation Criteria
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Eligibility Criteria
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BMI 18-32 kg/m2 (to avoid confounders with extreme obesity). Smoking or non-smoking. Having normal or clinically acceptable physical examination and clinical laboratory tests. Willing to abstain from beer consumption for four days prior to and during the study because beer contains XN and related prenylated (PN) flavonoids, such as IX, 8-PN and 6-PN. Not currently taking prescription drugs. Not having had acute medical conditions, such as hospitalizations or surgeries, at least three months prior to entry into the study. If female, not pregnant (as confirmed by urine pregnancy test), breastfeeding, or planning to become pregnant before completing the study, and using effective method of contraception (hormonal methods NOT permitted). If male with a partner of childbearing potential, willing to inform their partner of their participation in this clinical study and use highly effective methods of birth control during the study. Not currently following an extreme diet, such as Atkin's, Zone or Ornish, and willing to maintain their current diet without extreme changes for the duration of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 20 mg<br>Single dose 20 mg Xanthohumol | Dietary Supplement: Xanthohumol<br>* PK study with one capsule of one of the three doses randomly assigned<br>|
| 60 mg<br>Single dose 60 mg Xanthohumol | Dietary Supplement: Xanthohumol<br>* PK study with one capsule of one of the three doses randomly assigned<br>|
| 180 mg<br>Single dose 180 mg Xanthohumol | Dietary Supplement: Xanthohumol<br>* PK study with one capsule of one of the three doses randomly assigned<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of xanthohumol and metabolites. | The outcome measures will be the levels of xanthohumol and its metabolites in blood and urine following a single dose of 20 mg, 60mg, or 180 mg of xanthohumol over a course of six days. These levels will be used to determine the pharmacokinetics of xanthohumol in humans. | 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xanthohumol, Metabolic syndrome