Food-drug InteractionPhase 1NCT03948243
Licorice Botanical Dietary Supplements - Metabolism and Safety in Women
A Phase 1 study testing Licorice, Alprazolam 2 MG and Caffeine 100 MG in people with Food-drug Interaction, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Food-drug Interaction
- What is being tested?
- Licorice, Alprazolam 2 MG and Caffeine 100 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 22 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
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.
Read the 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
- Being tested
- Licorice, Alprazolam 2 MG, Caffeine 100 MG, Tolbutamide 250 mg, Dextromethorphan 30mg
- Keywords
- Licorice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LicoriceDietary supplement
Also called G. glabra
Experimental :G. glabra Licorice extract: 2 gelatin capsules (75 mg) per day for 14 days
Alprazolam 2 MGDrug
Also called CYP3A4/5 substrate
probe substrate
Caffeine 100 MGDrug
Also called CYP1A2 substrate
probe substrate
Tolbutamide 250 mgDrug
Also called CYP2C9 substrate
probe substrate
Dextromethorphan 30mgDrug
Also called CYP2D6 substrate
probe substrate
| Study group | Role | What they receive |
|---|---|---|
| G.Glabra | Experimental | single arm Receives: Dietary Supplement: Licorice; Drug: Alprazolam 2 MG; Drug: Caffeine 100 MG; Drug: Tolbutamide 250 mg; Drug: Dextromethorphan 30mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Area Under the Curve (AUC)
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.
Measured: baseline and 14 days
Secondary outcomes (4)
1. Apparent Clearance
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.
Measured: baseline and 14 days
2. Peak Concentration
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.
Measured: baseline and 14 days
3. Time for Peak Concentration
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.
Measured: baseline and 14 days
4. Drug Half-life [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.
Measured: baseline and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Apr 2019
- Primary completion31 Jul 2020
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food-drug InteractionStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon State University
- Responsible party
- Principal investigator, Richard B van Breemen, University of Illinois Chicago
- Investigators
- Richard vanBreemen, PhD, Study director, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948243
- Sponsor's protocol ID
- 2019-0115
- Status last verified
- May 2023
- First submitted
- 8 May 2019
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Licorice Botanical Dietary Supplements - Metabolism and Safety in Women
- ClinicalTrials.gov ID
- NCT03948243
- Acronym / sponsor ID
- 2019-0115
- Conditions
- Food-drug Interaction
- Keywords
- Licorice
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Oregon State University
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G.Glabra | Experimental | Dietary Supplement: Licorice, Drug: Alprazolam 2 MG, Drug: Caffeine 100 MG, Drug: Tolbutamide 250 mg, Drug: Dextromethorphan 30mgsingle arm |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LicoriceAlso: G. glabraExperimental :G. glabra Licorice extract: 2 gelatin capsules (75 mg) per day for 14 days | Dietary supplement | G.Glabra |
| Alprazolam 2 MGAlso: CYP3A4/5 substrateprobe substrate | Drug | G.Glabra |
| Caffeine 100 MGAlso: CYP1A2 substrateprobe substrate | Drug | G.Glabra |
| Tolbutamide 250 mgAlso: CYP2C9 substrateprobe substrate | Drug | G.Glabra |
| Dextromethorphan 30mgAlso: CYP2D6 substrateprobe substrate | Drug | G.Glabra |
Primary outcome
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.
4 secondary outcomes
1. Apparent Clearance
Time frame: baseline and 14 days
2. Peak Concentration
Time frame: baseline and 14 days
3. Time for Peak Concentration
Time frame: baseline and 14 days
4. Drug Half-life [Time Frame: baseline and 14 days]
Time frame: baseline and 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard vanBreemen, PhD study director
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Licorice, Alprazolam 2 MG and Caffeine 100 MG in people with Food-drug Interaction, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Area Under the Curve (AUC) (time frame: baseline and 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.