Xanthohumol and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Xanthohumol and Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367431
• Other study ID #: R21AT005294
• Secondary ID: R21AT005294
• Status: Completed
• Phase: N/A
• First received: March 15, 2011
• Last updated: July 23, 2015
• Start date: August 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2015
• Source: Oregon State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

• 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Xanthohumol
PK study with one capsule of one of the three doses randomly assigned

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon State University	National Center for Complementary and Integrative Health (NCCIH), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No