Phase
Condition
N/ATreatment
Placebo
Xanthohumol
Clinical Study ID
Ages 21-50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults 21-50 years of age
Active Crohn's disease not in remission based on a CDAI score >150
Willing to take isolated Xanthohumol as a dietary supplement for 8 weeks
Willing to have blood drawn bi-weekly and fast for 10-12 hours before blood draws
Willing and able to collect bi-weekly stool samples at home
Willing and able to collect a 24-hour urine sample before each study visit
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)
For individuals of child-bearing potential, willingness to use an intrauterinedevice (IUD) or two other concurrent forms of birth control (e.g., 2 of thefollowing categories: condoms, spermicide-containing gels, films or sponges; and/orvaginal rings) to prevent pregnancy while enrolled
Exclusion
Exclusion Criteria:
Highly variable dosing of anti-inflammatory medications (dose changes more than 1xper week)
Currently or recent (within last 14 days) taking any dietary supplements containingxanthohumol, flavonoids, or other known "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.
Consumption of more than 1 beer per day.
Currently receiving intravenous nutrition support therapy (or within the last 14days)
Currently taking anti-coagulant or anti-platelet prescription medications (or theywere taken within the last 14 days)
Currently taking antibiotic, antiparasitic, or antifungal medications orally orintravenously (or they were taken within the last 14 days)
Initiation of or changes to supplements or medications within 14 days prior toscreening.
Initiation of or changes to an exercise regimen within 14 days prior to screening.
Initiation of or changes to a food plan within 14 days prior to screening.
Current involvement or within 14 days prior to screening of a significant diet orweight loss program (such as NutriSystem, Jenny Craig, Atkin's or other low-carbdiet programs) or very low-calorie liquid diet programs (such as Optifast, Medifast,and/or HMR)
Hospitalization (for any reason other than a scheduled medical procedure) within 3months prior to screening
Gastrointestinal surgery within 3 months prior to screening
Malignancy within the last 5 years (with the exception of basal cell carcinoma,squamous cell carcinoma, and/or carcinoma in situ of the cervix)
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 perweek, or more than 4 in any single day within the past 14 days.
Smoking tobacco or nicotine products (combusted or vaporized)
Use of illicit drugs/substances (such as but not limited to cocaine, phencyclidine (PCP), and methamphetamine) within 14 days of screening
Use of inhaled or ingested Cannabis products, including Cannabidiol (CBD)
Currently participating in another interventional research study, or participated inanother interventional research study within 14 days of screening
Do not have an active primary care provider or specialist (i.e., gastroenterologist)managing their CD
Study Design
Study Description
Connect with a study center
National University of Natural Medicine
Portland, Oregon 97201
United StatesSite Not Available
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