Food-Drug InteractionsNCT02848430
Hop Botanical Dietary Supplements - Metabolism and Safety in Women
A study testing Humulus lupulus in people with Food-Drug Interactions, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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. 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 Interactions
- What is being tested?
- Humulus lupulus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2016to 24 Sep 2019
- Phase
- Interventional
- 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, 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
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
- 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
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 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.
Read the 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.
- Conditions
- Food-Drug Interactions
- Being tested
- Humulus lupulus
- Keywords
- Humulus lupulus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humulus lupulusDietary supplement
Also called hops
Extract of spent hops standardized to xanthohumol, isoxanthohumol, 6-prenylnaringenin, and 8-prenylnaringenin
| Study group | Role | What they receive |
|---|---|---|
| Humulus lupulus | Experimental | Spent hop extract; 2 gelatin capsules (59.5 mg extract) per day for 14 days Receives: Dietary Supplement: Humulus lupulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC)
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.
Measured: baseline and 14 days
Secondary outcomes (4)
Apparent Clearance
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.
Measured: baseline and 14 days
Peak Concentration
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.
Measured: baseline and 14 days
Time for Peak Concentration
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.
Measured: baseline and 14 days
Drug Half-life
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.
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 posted28 Jul 2016 (estimated)
- Study start15 Aug 2016
- Primary completion10 Sep 2018
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food-Drug InteractionsStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard B van Breemen, University of Illinois Chicago
- Investigators
- Richard B van Breemen, Ph.D., Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848430
- Sponsor's protocol ID
- 2015-0651
- Status last verified
- Aug 2020
- First submitted
- 22 Jul 2016
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 25045111van 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.
PubMed 32285669
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hop Botanical Dietary Supplements - Metabolism and Safety in Women
- ClinicalTrials.gov ID
- NCT02848430
- Acronym / sponsor ID
- 2015-0651
- Conditions
- Food-Drug Interactions
- Keywords
- Humulus lupulus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 28 Jul 2016 (estimated)
- 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 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Humulus lupulus | Experimental | Dietary Supplement: Humulus lupulusSpent hop extract; 2 gelatin capsules (59.5 mg extract) per day for 14 days |
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, 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
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 |
|---|---|---|
| Humulus lupulusAlso: hopsExtract of spent hops standardized to xanthohumol, isoxanthohumol, 6-prenylnaringenin, and 8-prenylnaringenin | Dietary supplement | Humulus lupulus |
Primary outcome
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.
4 secondary outcomes
Apparent Clearance
Time frame: baseline and 14 days
Peak Concentration
Time frame: baseline and 14 days
Time for Peak Concentration
Time frame: baseline and 14 days
Drug Half-life
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 28 Aug 2020.
- Background: PubMed 25045111van 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.
- Results publication: PubMed 32285669van 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.
- University of Illinois at Chicago / National Institutes of Health Center for Botanical Dietary SupplementsLink provided by the sponsor.
- 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 B van Breemen, Ph.D. principal investigator
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 study testing Humulus lupulus in people with Food-Drug Interactions, 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 28 Aug 2020. 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.
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?
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?
On the ClinicalTrials.gov record for NCT02848430, which also lists 2 linked publications.
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 28 Aug 2020.