- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02848430
Hop Botanical Dietary Supplements - Metabolism and Safety in Women
August 26, 2020 updated by: Richard B van Breemen, University of Illinois at Chicago
Human safety studies were 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) was 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 had predicted that the hop supplement might affect the metabolism or break down of these probe drugs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
At the start of a study, subjects were administered low doses of a mixture of four FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial blood samples were drawn and analyzed for the concentration of each drug over time.
Afterwards, participants consumed 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 were 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.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
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
Genders Eligible for Study
Female
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, 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
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: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Humulus lupulus
Spent hop extract; 2 gelatin capsules (59.5 mg extract) per day for 14 days
|
Extract of spent hops standardized to xanthohumol, isoxanthohumol, 6-prenylnaringenin, and 8-prenylnaringenin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve (AUC)
Time Frame: baseline and 14 days
|
Concentration of probe drugs from blood draws during the 14-day intervention were 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 |
---|---|---|
Apparent Clearance
Time Frame: baseline and 14 days
|
Concentration of probe drugs from blood draws during the 14-day intervention were used to calculate area under the (extrapolated) concentration-time curve to determine any changes compared to pre-intervention.
|
baseline and 14 days
|
Peak Concentration
Time Frame: baseline and 14 days
|
Concentration of probe drugs from blood draws during the 14-day intervention were used to calculate peak concentration of probe drug to determine any changes compared to pre-intervention.
|
baseline and 14 days
|
Time for Peak Concentration
Time Frame: baseline and 14 days
|
Concentration of probe drugs from blood draws during the 14-day intervention were used to calculate time for peak concentration of probe drug to determine any changes compared to pre-intervention.
|
baseline and 14 days
|
Drug Half-life
Time Frame: baseline and 14 days
|
Concentration of probe drugs from blood draws during the 14-day intervention were 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.
Investigators
- Principal Investigator: Richard B van Breemen, Ph.D., University of Illinois at Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- van Breemen RB, Yuan Y, Banuvar S, Shulman LP, Qiu X, Alvarenga RF, Chen SN, Dietz BM, Bolton JL, Pauli GF, Krause E, Viana M, Nikolic D. Pharmacokinetics of prenylated hop phenols in women following oral administration of a standardized extract of hops. Mol Nutr Food Res. 2014 Oct;58(10):1962-9. doi: 10.1002/mnfr.201400245. Epub 2014 Sep 16.
- van Breemen RB, Chen L, Tonsing-Carter A, Banuvar S, Barengolts E, Viana M, Chen SN, Pauli GF, Bolton JL. Pharmacokinetic Interactions of a Hop Dietary Supplement with Drug Metabolism in Perimenopausal and Postmenopausal Women. J Agric Food Chem. 2020 May 6;68(18):5212-5220. doi: 10.1021/acs.jafc.0c01077. Epub 2020 Apr 24.
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)
August 15, 2016
Primary Completion (ACTUAL)
September 10, 2018
Study Completion (ACTUAL)
September 24, 2019
Study Registration Dates
First Submitted
July 22, 2016
First Submitted That Met QC Criteria
July 27, 2016
First Posted (ESTIMATE)
July 28, 2016
Study Record Updates
Last Update Posted (ACTUAL)
August 28, 2020
Last Update Submitted That Met QC Criteria
August 26, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2015-0651
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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