Licorice Botanical Dietary Supplements - Metabolism and Safety in Women

2019-0115

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.

2019-04-01

2020-07-31

2022-04-22

Completed

Early phase I

19

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}

2023-05-06