A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease

Last updated: October 16, 2024
Sponsor: National University of Natural Medicine
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

Xanthohumol

Clinical Study ID

NCT04590508
Placeholder
  • Ages 21-50
  • All Genders

Study Summary

A pilot study to assess the safety and tolerability of an orally administered natural product derived from hops, called xanthohumol, in humans with Crohn's Disease, in order to identify a biological signature of xanthohumol exposure, and to characterize the role of xanthohumol metabolism by intestinal microorganisms in that signature within adults with Crohn's Disease.

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

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 01, 2020
Estimated Completion Date:
July 30, 2025

Study 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, particularly in individuals with gut pathologies such as Crohn's Disease. This information is necessary for the development of xanthohumol as a potential therapeutic intervention in such conditions.

Connect with a study center

  • National University of Natural Medicine

    Portland, Oregon 97201
    United States

    Site Not Available

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