Crohn DiseasePhase 2XMaSNCT04590508
A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease
A Phase 2 study testing Xanthohumol in people with Crohn Disease, run by National University of Natural Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Xanthohumol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 30 Jul 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
National University of Natural Medicine
Portland, Oregon, 97201
About this study
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.
Read the detailed 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.
- Conditions
- Crohn Disease
- Being tested
- Xanthohumol, Placebo
- Keywords
- Crohn's Disease, Inflammatory Bowel Disease, IBD, Xanthohumol, Humulus lupulus, Hops
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XanthohumolDrug
The xanthohumol supplement will be administered in a capsule and taken orally.
PlaceboOther
The placebo will be administered in a capsule and taken orally.
| Study group | Role | What they receive |
|---|---|---|
| Xanthohumol | Experimental | Participants will take capsules containing 24 mg of xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal. Receives: Drug: Xanthohumol |
| Placebo | Placebo comparator | Participants will receive capsules filled with a rice protein vehicle by mouth once daily with the first daily meal. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline: Aspartate aminotransferase (AST)
Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as: % abnormal, % new abnormals, and mean change from baseline.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Change from Baseline:Alanine aminotransferase (ALT)
Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as: % abnormal, % new abnormals, and mean change from baseline.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Change from Baseline: gamma-Glutamyl transferase (GGT)
Gamma-glutamyl transferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as: % abnormal, % new abnormals, and mean change from baseline.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Change from Baseline: Estimated glomerular filtration rate
Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. Reported as: % abnormal, % new abnormals, and mean change from baseline.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Change from Baseline: Blood urea nitrogen to creatinine ratio
Blood urea nitrogen:creatinine is a ratio of serum concentrations of two compounds associated with renal function. Reported as: % abnormal, % new abnormals, and mean change from baseline.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Change from Baseline: Complete blood count
Enumeration of the various subtypes of blood cells (i.e., red blood cells, white blood cells, and platelets), plus indices including mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), and hemocrit. Reported as: % abnormal, % new abnormals, and mean change from baseline.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Secondary outcomes (3)
Change from Baseline: Composite Symptoms: Crohn's Disease Activity Index (CDAI)
The Crohn's Disease Activity Index or CDAI is frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit. A CDAI score of less than 150 is considered to be remission, a score greater than 220 is considered to define moderate to severe disease, and a score greater than 300 is considered to be severe disease. Most major research studies on medications in Crohn's disease define response as a fall of the CDAI of greater than 70 points.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Change from Baseline: Change in fecal calprotectin levels
Fecal calprotectin, a protein associated with gut inflammation and irritable gut syndrome, will be measured by enzyme-linked immunosorbent assay, and expressed as mean change over time from baseline.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Change from Baseline: Change in plasma inflammatory markers (pg/mL)
Circulating pro-inflammatory cytokine concentrations (tumor necrosis factor (TNF)-α, interleukin (IL)-1β, IL-2, IL-6, IL-8, IL-10, , and IL-12p70), will be measured simultaneously with a flow cytometry-based multiplex assay. The results will be expressed as change from baseline over time.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Oct 2020
- Primary completion22 Aug 2024
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive either encapsulated xanthohumol in a rice protein vehicle, or an identical capsule containing vehicle alone.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon State University, Pacific Northwest National Laboratory
- Responsible party
- Sponsor
- Investigators
- Ryan Bradley, ND/MPH, Principal investigator, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590508
- Sponsor's protocol ID
- Placeholder
- Acronym
- XMaS
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2020
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will use the University of California San Diego (UCSD) Metabolomics Workbench for sharing metabolomics datasets and results (including raw data matrices, platform information, and associated metadata). For activity-based proteomics data, we will use PRIDE or the MassIVE data repository at UCSD. Nucleic acid sequence data will be submitted to the National Center for Biotechnology Information (NCBI) Short Read Archive. Gene expression data will be submitted to Gene expression Omnibus at NCBI. Microbiome metadata will be deposited into database of Genotypes and Phenotypes. Metagenomic nucleic acid sequence data will additionally be deposited in Metagenomic Rapid Annotations using Subsystems Technology (MG-RAST) at Argonne National Laboratory, along with associated metadata. Microbiome summary files (e.g., tables cataloging: sample metadata, taxon or protein family abundances across samples) publicly available through github.
Publications
Jamieson PE, Gu I, Reichart NJ, Maier CS, Ho E, Sharpton TJ, Metz TO, Bradley R, Stevens JF. Modulation of Microbiota-Derived Bile Acids Linked to Symptom Amelioration in Crohn's Disease: Insights From a Randomized Clinical Trial With Xanthohumol Supplementation. Mol Nutr Food Res. 2026 May;70(10):e70501. doi: 10.1002/mnfr.70501.
PubMed 42138225Bradley R, A Staab C, E Jamieson P, O Langley B, O Metz T, F Stevens J. Safety and Tolerability of Xanthohumol in Adults With Crohn's Disease: Results of a Triple-Masked, Randomized, Placebo-Controlled Phase 2 Trial. Mol Nutr Food Res. 2026 Mar;70(6):e70438. doi: 10.1002/mnfr.70438.
PubMed 41834265Langley BO, Ryan JJ, Phipps J, Buttolph L, Bray B, Aslan JE, Metz TO, Stevens JF, Bradley R. Xanthohumol microbiome and signature in adults with Crohn's disease (the XMaS trial): a protocol for a phase II triple-masked, placebo-controlled clinical trial. Trials. 2022 Oct 22;23(1):885. doi: 10.1186/s13063-022-06782-z.
PubMed 36273173
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease
- ClinicalTrials.gov ID
- NCT04590508
- Acronym / sponsor ID
- XMaS / Placeholder
- Conditions
- Crohn Disease
- Keywords
- Crohn's Disease, Inflammatory Bowel Disease, IBD, Xanthohumol, Humulus lupulus, Hops
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Collaborators
- Oregon State University, Pacific Northwest National Laboratory
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive either encapsulated xanthohumol in a rice protein vehicle, or an identical capsule containing vehicle alone.
| Arm | Type | Receives |
|---|---|---|
| Xanthohumol | Experimental | Drug: XanthohumolParticipants will take capsules containing 24 mg of xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive capsules filled with a rice protein vehicle by mouth once daily with the first daily meal. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XanthohumolThe xanthohumol supplement will be administered in a capsule and taken orally. | Drug | Xanthohumol |
| PlaceboThe placebo will be administered in a capsule and taken orally. | Other | Placebo |
Primary outcome
Change from Baseline: Aspartate aminotransferase (AST)
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as: % abnormal, % new abnormals, and mean change from baseline.
Change from Baseline:Alanine aminotransferase (ALT)
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as: % abnormal, % new abnormals, and mean change from baseline.
Change from Baseline: gamma-Glutamyl transferase (GGT)
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Gamma-glutamyl transferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as: % abnormal, % new abnormals, and mean change from baseline.
Change from Baseline: Estimated glomerular filtration rate
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. Reported as: % abnormal, % new abnormals, and mean change from baseline.
Change from Baseline: Blood urea nitrogen to creatinine ratio
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Blood urea nitrogen:creatinine is a ratio of serum concentrations of two compounds associated with renal function. Reported as: % abnormal, % new abnormals, and mean change from baseline.
Change from Baseline: Complete blood count
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Enumeration of the various subtypes of blood cells (i.e., red blood cells, white blood cells, and platelets), plus indices including mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), and hemocrit. Reported as: % abnormal, % new abnormals, and mean change from baseline.
3 secondary outcomes
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
Change from Baseline: Change in plasma inflammatory markers (pg/mL)
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Derived from this study: PubMed 42138225Jamieson PE, Gu I, Reichart NJ, Maier CS, Ho E, Sharpton TJ, Metz TO, Bradley R, Stevens JF. Modulation of Microbiota-Derived Bile Acids Linked to Symptom Amelioration in Crohn's Disease: Insights From a Randomized Clinical Trial With Xanthohumol Supplementation. Mol Nutr Food Res. 2026 May;70(10):e70501. doi: 10.1002/mnfr.70501.
- Derived from this study: PubMed 41834265Bradley R, A Staab C, E Jamieson P, O Langley B, O Metz T, F Stevens J. Safety and Tolerability of Xanthohumol in Adults With Crohn's Disease: Results of a Triple-Masked, Randomized, Placebo-Controlled Phase 2 Trial. Mol Nutr Food Res. 2026 Mar;70(6):e70438. doi: 10.1002/mnfr.70438.
- Derived from this study: PubMed 36273173Langley BO, Ryan JJ, Phipps J, Buttolph L, Bray B, Aslan JE, Metz TO, Stevens JF, Bradley R. Xanthohumol microbiome and signature in adults with Crohn's disease (the XMaS trial): a protocol for a phase II triple-masked, placebo-controlled clinical trial. Trials. 2022 Oct 22;23(1):885. doi: 10.1186/s13063-022-06782-z.
- Individual participant dataSharing planned: Yes. We will use the University of California San Diego (UCSD) Metabolomics Workbench for sharing metabolomics datasets and results (including raw data matrices, platform information, and associated metadata). For activity-based proteomics data, we will use PRIDE or the MassIVE data repository at UCSD. Nucleic acid sequence data will be submitted to the National Center for Biotechnology Information (NCBI) Short Read Archive. Gene expression data will be submitted to Gene expression Omnibus at NCBI. Microbiome metadata will be deposited into database of Genotypes and Phenotypes. Metagenomic nucleic acid sequence data will additionally be deposited in Metagenomic Rapid Annotations using Subsystems Technology (MG-RAST) at Argonne National Laboratory, along with associated metadata. Microbiome summary files (e.g., tables cataloging: sample metadata, taxon or protein family abundances across samples) publicly available through github.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Bradley, ND/MPH principal investigator
National University of Natural Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xanthohumol in people with Crohn Disease, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline: Aspartate aminotransferase (AST) (time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04590508, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.