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Hop Botanical Dietary Supplements - Metabolism and Safety in Women

NCT02848430 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-08-28

No results posted yet for this study

Summary

Human safety studies were carried out to test whether hop botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs. To test this, a hop dietary supplement (previously tested in women at the University of Illinois at Chicago without any harmful effects) was given with four selected FDA-approved drugs to determine if the hop supplement can increase or decrease how these medications are absorbed, metabolized and excreted by the human body. Preclinical studies had predicted that the hop supplement might affect the metabolism or break down of these probe drugs.

Conditions

  • Food-Drug Interactions

Interventions

DIETARY_SUPPLEMENT

Humulus lupulus

Extract of spent hops standardized to xanthohumol, isoxanthohumol, 6-prenylnaringenin, and 8-prenylnaringenin

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Richard B van Breemen, Ph.D. · University of Illinois at Chicago

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-15
Primary Completion
2018-09-10
Completion
2019-09-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02848430 on ClinicalTrials.gov