Xanthohumol and Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborators:
Oregon Health and Science University
Information provided by (Responsible Party):
Oregon State University
ClinicalTrials.gov Identifier:
NCT01367431
First received: March 15, 2011
Last updated: April 23, 2013
Last verified: April 2013

March 15, 2011
April 23, 2013
August 2011
April 2012   (final data collection date for primary outcome measure)
Levels of xanthohumol and metabolites. [ Time Frame: 6 days ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01367431 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Xanthohumol and Metabolic Syndrome
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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Healthy men and women in the Portland, Oregon area

Metabolic Syndrome
Dietary Supplement: Xanthohumol
PK study with one capsule of one of the three doses randomly assigned
  • 20 mg
    Single dose 20 mg Xanthohumol
    Intervention: Dietary Supplement: Xanthohumol
  • 60 mg
    Single dose 60 mg Xanthohumol
    Intervention: Dietary Supplement: Xanthohumol
  • 180 mg
    Single dose 180 mg Xanthohumol
    Intervention: Dietary Supplement: Xanthohumol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2012
April 2012   (final data collection date for primary outcome measure)
  • 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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01367431
R21AT005294, R21AT005294
Yes
Oregon State University
Oregon State University
  • Oregon Health and Science University
  • National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Jan F Stevens, PhD Oregon State University
Principal Investigator: Jon Q Purnell, MD Oregon Health and Science University
Oregon State University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP