Xanthohumol and Metabolic Syndrome

NCT01367431 | Completed DMC

• 1 other identifier: R21AT005294
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Xanthohumol; Metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

20 mg

Single dose 20 mg Xanthohumol

Dietary Supplement: Xanthohumol

60 mg

Single dose 60 mg Xanthohumol

Dietary Supplement: Xanthohumol

180 mg

Single dose 180 mg Xanthohumol

Dietary Supplement: Xanthohumol

Interventions

Xanthohumol DIETARY_SUPPLEMENT

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

180 mg; 20 mg; 60 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy men and women in the Portland, Oregon area

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Oregon State University: lead
• Oregon Health and Science University: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

xanthohumol

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jan F Stevens, PhD

  Oregon State University

  PRINCIPAL INVESTIGATOR

• Jon Q Purnell, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicinal Chemistry, Department of Pharmaceutical Sciences, College of Pharmacy

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: June 7, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

US (1)