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Xanthohumol and Metabolic Syndrome

Xanthohumol and Metabolic Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01367431
Enrollment
48
Registered
2011-06-07
Start date
2011-08-31
Completion date
2012-04-30
Last updated
2015-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

Xanthohumol, Metabolic syndrome

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTXanthohumol

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

Sponsors

Oregon Health and Science University
CollaboratorOTHER
National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Oregon State University
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Levels of xanthohumol and metabolites.6 daysThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026