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Licorice Botanical Dietary Supplements - Metabolism and Safety in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948243
Recruitment Status : Active, not recruiting
First Posted : May 13, 2019
Last Update Posted : November 6, 2020
Sponsor:
Collaborator:
Oregon State University
Information provided by (Responsible Party):
Elena Barengolts, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date November 6, 2020
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
1. Area Under the Curve (AUC) [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 area under the (extrapolated) concentration-time curve to determine any changes compared to pre-intervention.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Licorice Botanical Dietary Supplements - Metabolism and Safety in Women
Official Title  ICMJE Licorice Botanical Dietary Supplements - Metabolism and Safety in Women
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Food-drug Interaction
Intervention  ICMJE
  • Dietary Supplement: Licorice
    Experimental :G.Glabra Licorice extract: 2 gelatin capsules (75 mg) per day for 14 days
    Other Name: G.Glabra
  • Drug: Alprazolam 2 MG
    substrate
  • Drug: Caffeine 100 MG
    substrate
  • Drug: Tolbutamide 250 mg
    substrate
  • Drug: Dextromethorphan 30mg
    substrate
Study Arms  ICMJE Experimental: G.Glabra
single arm
Interventions:
  • Dietary Supplement: Licorice
  • Drug: Alprazolam 2 MG
  • Drug: Caffeine 100 MG
  • Drug: Tolbutamide 250 mg
  • Drug: Dextromethorphan 30mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 5, 2020)
19
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2019)
20
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 40 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948243
Other Study ID Numbers  ICMJE 2019-0115
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Elena Barengolts, University of Illinois at Chicago
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE Oregon State University
Investigators  ICMJE
Principal Investigator: Elena I Barengolts, MD University of Illinois at Chicago
PRS Account University of Illinois at Chicago
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP