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. 2022 Oct 22;23:885. doi: 10.1186/s13063-022-06782-z

Table 2.

Participant eligibility

Inclusion criteria Exclusion criteria

• Adults 21–70 years of age

• Active Crohn’s disease not in remission based on a CDAI score >150

• Willing to take isolated XN as a dietary supplement for 8 weeks

• Willing to have blood drawn biweekly and fast for 10–12 h before blood draws

• Willing and able to collect biweekly stool samples at home

• Willing and able to collect a 24-h urine sample before each study visit

• Able to speak, read, and understand English

• Able to provide written informed consent

• Non-smokers (including tobacco and Cannabis products in any delivery including cannabidiol)

• For individuals of child-bearing potential, willing to use an intrauterine device or two other concurrent forms of birth control to prevent pregnancy while enrolled

• Variable dosing of anti-inflammatory medications >1×/week

• Currently or recent (within last 14 days):

o Taking any dietary supplements containing xanthohumol, flavonoids, or other “anti-inflammatories” including curcumin, turmeric, fenugreek, hops, rosemary, ginger, white willow, devil’s claw, fish oil (doses >1 g/day), or quercetin

o Receiving intravenous nutrition support therapy

o Taking anti-coagulant or anti-platelet prescription medications

o Taking antibiotic, antiparasitic, or antifungal medications orally or intravenously

o Initiated of or changes to supplements or medications

o Initiated or changes to an exercise regimen

o Initiated changes to a food plan

o Involvement of a significant diet, weight loss, or very low-calorie liquid diet programs

o Use of illicit drugs/substances

o Participation in an interventional research study

• Consumption of more than 1 beer per day or 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

• Hospitalization (for any reason other than a scheduled medical procedure) within the last 3 months

• Gastrointestinal surgery within the last 3 months

• Malignancy within the last 5 years (except 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 4 months

• Do not have an active primary care provider or specialist (i.e., gastroenterologist) managing their CD