Xanthohumol and Metabolic Syndrome

Oregon State University (OSU)

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Dietary Supplement: Xanthohumol

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT01367431

R21AT005294 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.