Xanthohumol and Metabolic Syndrome

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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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xanthohumol

Dietary Supplement

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

Primary outcomes

Levels of xanthohumol and metabolites.

Time frame: 6 days

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.

Sponsors and collaborators

Lead sponsor

Oregon State University

Other

Collaborators

National Center for Complementary and Integrative Health (NCCIH)
Oregon Health and Science University

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jun 7, 2011
Registry last updated: Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed