Xanthohumol Metabolism and Signature (XMaS)

National University of Natural Medicine (NUNM)

Status and phase

Active, not recruiting

Phase 1

Conditions

Healthy

Treatments

Drug: Xanthohumol

Drug: Placebo oral capsule

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT03735420

RB9718

Details and patient eligibility

About

A pilot study to assess the safety and tolerability of oral xanthohumol in humans, to identify a biological signature of xanthohumol exposure, and to characterize the role of xanthohumol metabolism by intestinal microorganisms in that signature.

Full description

This is a double-masked, placebo controlled, randomized clinical trial of xanthohumol, which is a constituent of hops (Humulus lupulus). Hops and its constituents have a long history of use for a variety of conditions. However, knowledge is limited regarding the measurable biological markers of human exposure, and the role of xanthohumol metabolism by microorganisms present in the gut. This information is necessary for the development of xanthohumol as a potential therapeutic intervention in conditions such as inflammatory bowel disease.

Enrollment

30 patients

Sex

All

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Men and Women aged 21-50 years
Willing to take isolated xanthohumol as a dietary supplement for 8 weeks
Willing to have blood drawn semi-weekly and to fast for 10-12 hours before blood draws
Willing and able to collect semi-weekly stool samples at home
Able to speak, read, and understand English
Must be able to provide written informed consent
Non-smokers (including tobacco and Cannabis products, combusted or vaporized)

Exclusion criteria

History of any chronic disease including, but not limited to: diabetes (type 1 or 2); uncontrolled hypertension; coronary artery disease resulting in angina; cardiovascular disease requiring percutaneous coronary intervention (PCI), bypass, or past myocardial infarction or stroke; blood disease including current anemia; cancer (except non-melanoma skin cancer) within the last year or still requiring chemotherapy or hormonal therapy; chronic kidney disease; liver disease including viral hepatitis, non-alcoholic fatty liver disease, or alcoholic hepatitis/cirrhosis; any immunocompromising condition including human immunodeficiency virus/acquired immunodeficiency syndrome or organ transplant requiring anti-rejection medications; chronic osteoarthritis requiring joint replacement or daily use of NSAIDs; chronic endocrine condition including but not limited to: Cushing's, Addison's, Hashimoto's thyroiditis, Grave's disease, etc.
Body Mass Index (BMI) less than 20 (underweight) or greater than 30 (obese)
Consumption of more than 1 microbrew beer per day
Use of NSAIDs more than once per week for headaches, routine aches/pains, etc.
Use of any prescription drugs, including oral contraceptives (due to potential interference with mechanisms under investigation)
Use of prescription opioids for any reason within the past 3 months
Use of prescription corticosteroids for any reason within the past 3 months
Free of acute viral or bacterial infection, or recent infection within the last 14 days or still requiring prescription medication for treatment
Free of recent acute trauma occurring within the last 14 days
Currently or recently (within last 14 days) taking any dietary supplements containing xanthohumol flavonoids, or other known herbal "anti-inflammatories" including: curcumin, turmeric, fenugreek, hops, rosemary, ginger, white willow, Devil's claw, fish oil (doses>1 g/day), or quercetin. Candidates will be given the option to "wash out" for 14 days and re-contact the study team.
Currently receiving intravenous nutrition support therapy (or within the last 30 days)
Currently taking anti-coagulant or anti-platelet prescription medications (or they were taken within the last 30 days)
Currently taking antibiotic, antiparasitic, or antifungal medications orally or intravenously (or they were taken within the last 30 days)
Initiation of or changes to supplements or medications within 30 days prior to screening
Initiation of or changes to an exercise regimen within 30 days prior to screening
Initiation of or changes to a food plan within 30 days prior to screening
Current involvement or within 30 days prior to screening of a significant diet or weight loss program, such as NutriSystem, Jenny Craig, Atkin's or other low-carb diet programs, or very low-calorie liquid diet programs (such as optifast, medifast, and/or HMR)
Hospitalization (for any reason other than an elective medical procedure) within 3 months prior to screening
Gastrointestinal surgery within 3 months prior to screening
Undergoing UV therapy (e.g. treatment for skin conditions such as psoriasis).
Engaging in vigorous exercise more than 6 hours per week.
Women who are lactating, pregnant or planning pregnancy within the next four months
Typical intake of more than 2 alcohol-containing beverages per day, more than 14 per week, or more than 4 in any single day within the past 28 days
Use of recreational drugs/substances (such as but not limited to cocaine, phencyclidine (PCP), and methamphetamine) within 30 days of screening
Currently participating in another interventional research study or participated in another interventional study within 30 days of screening