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Hop 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: NCT02848430
Recruitment Status : Active, not recruiting
First Posted : July 28, 2016
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Richard B van Breemen, University of Illinois at Chicago

Brief Summary:
Human safety studies will be 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) will be 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 predict that the hop supplement might affect the metabolism or break down of these probe drugs.

Condition or disease Intervention/treatment Phase
Food-Drug Interactions Dietary Supplement: Humulus lupulus Not Applicable

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 hop 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 hop dietary supplement.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Hop Botanical Dietary Supplements - Metabolism and Safety in Women
Study Start Date : August 2016
Estimated Primary Completion Date : October 18, 2018
Estimated Study Completion Date : October 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Humulus lupulus
Spent hop extract; 2 gelatin capsules (59.5 mg extract) per day for 14 days
Dietary Supplement: Humulus lupulus
Extract of spent hops standardized to xanthohumol, isoxanthohumol, 6-prenylnaringenin, and 8-prenylnaringenin
Other Name: hops




Primary Outcome Measures :
  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.


Secondary Outcome Measures :
  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 area under the (extrapolated) concentration-time curve 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848430


Locations
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United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Richard B van Breemen, Ph.D. University of Illinois at Chicago

Additional Information:
Publications:
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Responsible Party: Richard B van Breemen, Principal Investigator, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02848430    
Other Study ID Numbers: 2015-0651
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Richard B van Breemen, University of Illinois at Chicago:
Humulus lupulus