Xanthohumol and Metabolic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-04-30

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.

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Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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20 mg

Single dose 20 mg Xanthohumol

Xanthohumol

Intervention Type DIETARY_SUPPLEMENT

PK study with one capsule of one of the three doses randomly assigned

60 mg

Single dose 60 mg Xanthohumol

Xanthohumol

Intervention Type DIETARY_SUPPLEMENT

PK study with one capsule of one of the three doses randomly assigned

180 mg

Single dose 180 mg Xanthohumol

Xanthohumol

Intervention Type DIETARY_SUPPLEMENT

PK study with one capsule of one of the three doses randomly assigned

Interventions

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Xanthohumol

PK study with one capsule of one of the three doses randomly assigned

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes