Advertisement

Topics

Hop Botanical Dietary Supplements - Metabolism and Safety in Women

2016-07-29 04:08:21 | BioPortfolio

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.

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Food-Drug Interactions

Intervention

Humulus lupulus

Status

Not yet recruiting

Source

University of Illinois at Chicago

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-07-29T04:08:21-0400

Clinical Trials [1198 Associated Clinical Trials listed on BioPortfolio]

Older HIV-infected Adults and Drug Interactions: French Cross-sectional Study

Drug interactions between antiretroviral drugs and concomitants drugs and between antiretroviral need to be studied HIV-population is ageing. The referential of interactions is the Liverpo...

Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs

This is open label, phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment (Child - Pugh Clas...

Oral Bioavailability and Bioactivity of Prenylflavonoids From Hops

The prenylflavonoids 6-prenylnaringenin (6-PN) and 8-prenylnaringenin (8-PN) are secondary plant substances, almost exclusively found in hops (Humulus lupulus). Both compounds have known p...

DDI Effectiveness and Clinical Awareness

The DECART study will determine if primary care physicians, including internists and family physicians, are able to identify and address drug-drug interactions among simulated patients and...

Increasing the Oral Bioavailability of 6-prenylnaringenin by Micellar Solubilization

Micellar encapsulation will be tested to increase the oral bioavailability in humans of 6-prenylnaringenin (6-PN) from hops (Humulus lupulus). The study follows a single dose (250 mg 6-PN)...

PubMed Articles [15746 Associated PubMed Articles listed on BioPortfolio]

Medicinal properties of terpenes found in Cannabis sativa and Humulus lupulus.

Cannabaceae plants Cannabis sativa L. and Humulus lupulus L. are rich in terpenes - both are typically comprised of terpenes as up to 3-5% of the dry-mass of the female inflorescence. Terpenes of cann...

Potential Drug-Drug Interactions with Antimicrobials in Hospitalized Patients: A Multicenter Point-Prevalence Study.

BACKGROUND Improper use of antimicrobials can cause adverse drug events and high costs. The purpose of this study was to investigate the frequency and potential drug-drug interactions associated with ...

In vitro effects of rebaudioside A, stevioside and steviol on porcine cytochrome p450 expression and activity.

The physiological effects of the Stevia-derived compounds, rebaudioside A, stevioside and steviol have been the focus of several studies due to their use as sweeteners in food. Despite that, little is...

FDA Public Meeting Report on "Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications".

Potential drug interactions with hormonal contraceptives are an important public health concern. A public meeting on "Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development...

The case-crossover design for drug-drug interactions: considerations for implementation.

The case-crossover design may be useful for evaluating the clinical impact of drug-drug interactions in electronic healthcare data; however, experience with the design in this context is limited.

Medical and Biotech [MESH] Definitions

A plant genus in the CANNABACEAE family. Best known for the buds of Humulus lupulus L. used in BEER.

Specific effects of drugs and substances on metabolic pathways such as those occurring through the CYTOCHROME P-450 ENZYME SYSTEM. These include effects that often result in DRUG INTERACTIONS; FOOD-DRUG INTERACTIONS; and HERB-DRUG INTERACTIONS.

The pharmacological result, either desirable or undesirable, of drugs interacting with components of the diet. (From Stedman, 25th ed)

The action of a drug that may affect the activity, metabolism, or toxicity of another drug.

The properties and processes of drug metabolism and drug interactions.

More From BioPortfolio on "Hop Botanical Dietary Supplements - Metabolism and Safety in Women"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Drug Approvals
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...


Searches Linking to this Trial