Trial Summary
What is the purpose of this trial?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
Adults aged 21-50 with active Crohn's Disease (CDAI score >150) who are non-smokers, willing to fast before blood draws, collect stool and urine samples bi-weekly, and use reliable contraception if of child-bearing potential. Excluded are those on certain medications or diets recently, hospitalized or had GI surgery within the last 3 months, pregnant women, heavy drinkers/smokers, or using illicit drugs.Inclusion Criteria
I am willing to use an IUD or two other forms of birth control during the study.
I am between 21 and 50 years old.
I am willing to take a dietary supplement for 8 weeks.
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Exclusion Criteria
My anti-inflammatory medication dose changes frequently.
You started a new exercise routine or changed your existing one within 2 weeks before screening.
You have changed your diet within two weeks before screening.
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Participant Groups
The trial is testing xanthohumol's safety and effects in adults with Crohn's Disease. Participants will take an oral supplement derived from hops for 8 weeks while their biological response is monitored through blood tests, stool samples, and urine collection to understand how gut microbes metabolize it.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: XanthohumolExperimental Treatment1 Intervention
Participants will take capsules containing 24 mg of xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive capsules filled with a rice protein vehicle by mouth once daily with the first daily meal.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National University of Natural MedicinePortland, OR
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Who Is Running the Clinical Trial?
National University of Natural MedicineLead Sponsor
Oregon State UniversityCollaborator
Pacific Northwest National LaboratoryCollaborator