Licorice Botanical Dietary Supplements - Metabolism and Safety in Women

Food-drug Interaction Clinical Trial

Official title:

Licorice Botanical Dietary Supplements - Metabolism and Safety in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03948243
• Other study ID #: 2019-0115
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2019
• Est. completion date: April 22, 2022

Study information

• Verified date: May 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

At the start of a study, subjects will be administered low doses of a mixture of four FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial blood samples will be drawn and analyzed for the concentration of each drug over time. Afterwards, participants will take the licorice dietary supplement twice daily for 14 days to allow for potential inhibition or induction of drug metabolizing enzymes and transporters. Thereafter, the same drugs will be taken again to obtain a second measure of drug concentrations in blood over time. Changes in the concentration-time curve values for each probe drug obtained before and after ingestion of the supplement would indicate that metabolism of the probe drugs is impacted by the licorice dietary supplement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 22, 2022
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 79 Years

Eligibility

Inclusion Criteria:

• healthy peri- and post-menopausal women ages 40 - 79

• non-smokers

• no-significant medical conditions as assessed by subject-reported medical history, physical examination and blood and urine chemistry screens

• no medical condition that requires chronic use of medication

Exclusion Criteria:

• known allergies or hypersensitivity to caffeine, dextromethorphan, sulfonylureas (tolbutamide), benzodiazepines, or licorice

• positive pregnancy test

• use of hormone therapy within 8 weeks of study initiation for oral agents, 4 weeks for transdermal or other topical agents

• use of caffeine products 7 days before study participation or during the study

• use of citrus products 7 days before study participation or during the study

• other prescription (with the exception of the Mirena® IUD) or non-prescription medicines within the 2 weeks prior to study initiation or during the study

• chronic diseases, such as inflammatory bowel disease, that could alter the absorption or metabolism of the probe substrates

• unwillingness to comply with study requirements

• current participation in another clinical trial

• CYP2D6 deficiency based on phenotyping at screening

• smoker

• licorice (whether as a botanical dietary supplement, candy, food, drink or otherwise) within the previous two weeks and during the study

• use of any dietary supplements within the last 2 weeks prior to study initiation and during the study

• extreme obesity (defined as >40 BMI)

• alcohol or drug abuse

• chronic diseases such as diabetes.

Related Conditions & MeSH terms

• Food-drug Interaction

Intervention

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

Drug:
• Alprazolam 2 MG
probe substrate
• Caffeine 100 MG
probe substrate
• Tolbutamide 250 mg
probe substrate
• Dextromethorphan 30mg
probe substrate

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Oregon State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Area Under the Curve (AUC)	Concentration of probe drugs from blood draws during the 14-day intervention will be used to calculate area under the (extrapolated) concentration-time curve to determine any changes compared to pre-intervention.	baseline and 14 days
Secondary	1. Apparent Clearance	Concentration of probe drugs from blood draws during the 14-day intervention will be used to calculate apparent clearance of probe drug to determine any changes compared to pre-intervention.	baseline and 14 days
Secondary	2. Peak Concentration	Concentration of probe drugs from blood draws during the 14-day intervention will be used to calculate peak concentration of probe drug to determine any changes compared to pre-intervention.	baseline and 14 days
Secondary	3. Time for Peak Concentration	Concentration of probe drugs from blood draws during the 14-day intervention will be used to calculate time for peak concentration of probe drug to determine any changes compared to pre-intervention.	baseline and 14 days
Secondary	4. Drug Half-life [Time Frame: baseline and 14 days]	Concentration of probe drugs from blood draws during the 14-day intervention will be used to calculate half-life of probe drug to determine any changes compared to pre-intervention.	baseline and 14 days