NCT02848430

Hop Botanical Dietary Supplements - Metabolism and Safety in Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: Female
• Age: 40 Years – 79 Years
• Healthy volunteers: Accepted

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.

Detailed description

At the start of a study, subjects were administered low doses of a mixture of four FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial blood samples were drawn and analyzed for the concentration of each drug over time. Afterwards, participants consumed the hop dietary supplement twice daily for 14 days to allow for potential inhibition or induction of drug metabolizing enzymes and transporters. Thereafter, the same drugs were 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 hop dietary supplement.

Conditions

• Food-Drug Interactions

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Humulus lupulus	Extract of spent hops standardized to xanthohumol, isoxanthohumol, 6-prenylnaringenin, and 8-prenylnaringenin

Timeline

• Start date: 2016-08-15
• Primary completion: 2018-09-10
• Completion: 2019-09-24
• First posted: 2016-07-28
• Last updated: 2020-08-28

Locations

1 site across 1 country: United States