NCT03948243

Licorice Botanical Dietary Supplements - Metabolism and Safety in Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: Female
• Age: 40 Years – 79 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Food-drug Interaction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-07-31
• Completion: 2022-04-22
• First posted: 2019-05-13
• Last updated: 2023-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study