- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03948243
Licorice Botanical Dietary Supplements - Metabolism and Safety in Women
May 3, 2023 updated by: Richard B van Breemen, University of Illinois at Chicago
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: G.Glabra
single arm
|
Experimental :G.
glabra Licorice extract: 2 gelatin capsules (75 mg) per day for 14 days
Other Names:
probe substrate
Other Names:
probe substrate
Other Names:
probe substrate
Other Names:
probe substrate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1. Area Under the Curve (AUC)
Time Frame: baseline and 14 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1. Apparent Clearance
Time Frame: baseline and 14 days
|
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
|
2. Peak Concentration
Time Frame: baseline and 14 days
|
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
|
3. Time for Peak Concentration
Time Frame: baseline and 14 days
|
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
|
4. Drug Half-life [Time Frame: baseline and 14 days]
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
July 31, 2020
Study Completion (Actual)
April 22, 2022
Study Registration Dates
First Submitted
May 8, 2019
First Submitted That Met QC Criteria
May 10, 2019
First Posted (Actual)
May 13, 2019
Study Record Updates
Last Update Posted (Estimate)
May 5, 2023
Last Update Submitted That Met QC Criteria
May 3, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Purinergic Antagonists
- Purinergic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Respiratory System Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Central Nervous System Stimulants
- Antitussive Agents
- Dextromethorphan
- Caffeine
- Alprazolam
- Tolbutamide
Other Study ID Numbers
- 2019-0115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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