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Licorice Botanical Dietary Supplements - Metabolism and Safety in Women

NCT03948243 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-05-06

No results posted yet for this study

Summary

Human safety studies will be carried out to test whether red clover 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 red clover dietary supplement (previously tested in women at the University of Illinois at Chicago without any harmful effects) will be given with four selected FDA-approved drugs to determine if the Licorice supplement can increase or decrease how these medications are absorbed, metabolized and excreted by the human body. Preclinical studies predict that the licorice supplement might affect the metabolism or break down of these probe drugs.

Conditions

  • Food-drug Interaction

Interventions

DIETARY_SUPPLEMENT

Licorice

Experimental :G. glabra Licorice extract: 2 gelatin capsules (75 mg) per day for 14 days

DRUG

Alprazolam 2 MG

probe substrate

DRUG

Caffeine 100 MG

probe substrate

DRUG

Tolbutamide 250 mg

probe substrate

DRUG

Dextromethorphan 30mg

probe substrate

Sponsors & Collaborators

  • Oregon State University

    collaborator OTHER

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Richard vanBreemen, PhD · University of Illinois at Chicago

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-07-31
Completion
2022-04-22
FDA Drug
Yes

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 NCT03948243 on ClinicalTrials.gov