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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 21 Years - 50 Years
Gender All
More Inclusion & Exclusion Criteria

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 intrauterine device (IUD) or two other concurrent forms of birth control (e.g., 2 of the following categories: condoms, spermicide-containing gels, films or sponges; and/or vaginal rings) to prevent pregnancy while enrolled.

Exclusion Criteria:

  • - Highly variable dosing of anti-inflammatory medications (dose changes more than 1x per week) - Currently or recent (within last 14 days) taking any dietary supplements containing xanthohumol, 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 14 days) - Currently taking anti-coagulant or anti-platelet prescription medications (or they were taken within the last 14 days) - Currently taking antibiotic, antiparasitic, or antifungal medications orally or intravenously (or they were taken within the last 14 days) - Initiation of or changes to supplements or medications within 14 days prior to screening.
  • - 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 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 a scheduled medical procedure) within 3 months 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 per week, 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 in another interventional research study within 14 days of screening.
- Do not have an active primary care provider or specialist (i.e., gastroenterologist) managing their CD

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04590508
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National University of Natural Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherU.S. Fed
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Additional Details

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.

Arms & Interventions

Arms

Experimental: Xanthohumol

Participants will take capsules containing 24 mg of xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.

Placebo Comparator: Placebo

Participants will receive capsules filled with a rice protein vehicle by mouth once daily with the first daily meal.

Interventions

Drug: - Xanthohumol

The xanthohumol supplement will be administered in a capsule and taken orally.

Other: - Placebo

The placebo will be administered in a capsule and taken orally.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

National University of Natural Medicine, Portland, Oregon

Status

Recruiting

Address

National University of Natural Medicine

Portland, Oregon, 97201

Site Contact

Emily Stack

microbiome@nunm.edu

503-552-1777

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