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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Xanthohumol

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97201
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy men and women in the Portland, Oregon area

Description

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of xanthohumol and metabolites.	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.	6 days

Collaborators and Investigators

• Sponsor: Oregon State University
• Collaborators: Oregon Health and Science University; National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Jan F Stevens, PhD, Oregon State University; Principal Investigator: Jon Q Purnell, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: March 15, 2011
• First Submitted That Met QC Criteria: June 3, 2011
• First Posted (ESTIMATE): June 7, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 24, 2015
• Last Update Submitted That Met QC Criteria: July 23, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Xanthohumol
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Xanthohumol
• Other Study ID Numbers: R21AT005294 (NIH)