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Xanthohumol and Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborators:
Oregon Health and Science University
National Center for Complementary and Alternative Medicine (NCCAM)
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
History of Changes
  Purpose

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.


Condition Intervention
Metabolic Syndrome
 Dietary Supplement: Xanthohumol

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Xanthohumol and Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon State University:

Primary Outcome Measures:
  • 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.


Enrollment: 48
Study Start Date: August 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
20 mg
Single dose 20 mg Xanthohumol
 Dietary Supplement: Xanthohumol
PK study with one capsule of one of the three doses randomly assigned
60 mg
Single dose 60 mg Xanthohumol
 Dietary Supplement: Xanthohumol
PK study with one capsule of one of the three doses randomly assigned
180 mg
Single dose 180 mg Xanthohumol
 Dietary Supplement: Xanthohumol
PK study with one capsule of one of the three doses randomly assigned

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy men and women in the Portland, Oregon area

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367431

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Oregon State University
Oregon Health and Science University
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Jan F Stevens, PhD Oregon State University
Principal Investigator: Jon Q Purnell, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Oregon State University
ClinicalTrials.gov Identifier: NCT01367431     History of Changes
Other Study ID Numbers: R21AT005294, R21AT005294
Study First Received: March 15, 2011
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon State University:
Xanthohumol
Metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013