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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 October 2024
• Main ID: NCT04590508
• Date of registration: 28/09/2020
• Prospective Registration: Yes
• Primary sponsor: National University of Natural Medicine
• Public title: A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease XMaS
• Scientific title: A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease
• Date of first enrolment: October 1, 2020
• Target sample size: 20
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04590508
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Ryan Bradley, ND/MPH
• Affiliation: National University of Natural Medicine

Key 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


Age minimum: 21 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Xanthohumol

Other: Placebo

Primary Outcome(s)

Change from Baseline: Complete blood count [Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks]

Change from Baseline: Aspartate aminotransferase (AST) [Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks]

Change from Baseline: Estimated glomerular filtration rate [Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks]

Change from Baseline: gamma-Glutamyl transferase (GGT) [Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks]

Change from Baseline:Alanine aminotransferase (ALT) [Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks]

Change from Baseline: Blood urea nitrogen to creatinine ratio [Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks]

Secondary Outcome(s)

Change from Baseline: Change in plasma inflammatory markers (pg/mL) [Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks]

Change from Baseline: Composite Symptoms: Crohn's Disease Activity Index (CDAI) [Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks]

Change from Baseline: Change in fecal calprotectin levels [Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks]

Secondary ID(s)

Placeholder

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Oregon State University

Pacific Northwest National Laboratory