Hop Botanical Dietary Supplements - Metabolism and Safety in Women

NCT02848430 | Completed DMC

• 1 other identifier: 2015-0651
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Food-Drug Interactions

Keywords

Humulus lupulus

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 14 days

Secondary Outcomes (4)

• Apparent Clearance

  baseline and 14 days

• Peak Concentration

  baseline and 14 days

• Time for Peak Concentration

  baseline and 14 days

• Drug Half-life

  baseline and 14 days

Study Arms (1)

Humulus lupulus

EXPERIMENTAL

Spent hop extract; 2 gelatin capsules (59.5 mg extract) per day for 14 days

Dietary Supplement: Humulus lupulus

Interventions

Humulus lupulus DIETARY_SUPPLEMENT

Extract of spent hops standardized to xanthohumol, isoxanthohumol, 6-prenylnaringenin, and 8-prenylnaringenin

Also known as: hops

Humulus lupulus

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

• 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.

  PMID: 25045111 BACKGROUND

• 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.

  PMID: 32285669 RESULT

Related Links

• University of Illinois at Chicago / National Institutes of Health Center for Botanical Dietary Supplements

MeSH Terms

Interventions

ALPL protein, human

Study Officials

• Richard B van Breemen, Ph.D.

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 28, 2016
• Study Start: August 15, 2016
• Primary Completion: September 10, 2018
• Study Completion: September 24, 2019
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)