Hop Botanical Dietary Supplements - Metabolism and Safety in Women

Completed · Not applicable

Conditions studied: Food-Drug Interactions

In brief

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.

Key facts

Study ID

NCT02848430

Run by

University of Illinois at Chicago

People needed

22

Starts

2016-08-15

Expected to finish

2019-09-24

Last updated by the study team

2020-08-28

Who can join

Age: 40 and older, up to 79. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• known allergies or hypersensitivity to caffeine, dextromethorphan, sulfonylureas (tolbutamide), benzodiazepines, red clover, licorice, or hops
• 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
• use of 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
• hops intake (whether as a botanical dietary supplement or beer) 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
• obesity (defined as >33 BMI)
• alcohol or drug abuse
• chronic diseases such as inflammatory bowel disease or diabetes

Where it is running

• University of Illinois at Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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