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NCT04590508: XMaS
A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease
Phase 2 trial testing Xanthohumol in Crohn Disease in 20 participants. Participants enrolled and being followed up; not accepting new ones.
22 August 2024
Quick facts
| Lead sponsor | National University of Natural Medicine |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 October 2020 |
| Primary completion | 22 August 2024 |
| Estimated completion | 30 July 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Xanthohumol — full drug profile →
- Placebo
Conditions studied
- Crohn Disease — all drugs for Crohn Disease →
Sponsor
National University of Natural Medicine
Who can join
Adults 21 to 50, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
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.
Langley BO, Ryan JJ, Phipps J, Buttolph L, et al · · 2022 · cited 12× · PMID 36273173 · DOI 10.1186/s13063-022-06782-z -
Use of Lipid-Modifying Agents for the Treatment of Glomerular Diseases.
Ge M, Merscher S, Fornoni A. · · 2021 · cited 10× · PMID 34442464 · DOI 10.3390/jpm11080820 -
Synergistic Anticancer Activity of Plumbagin and Xanthohumol Combination on Pancreatic Cancer Models.
Palanisamy R, Indrajith Kahingalage N, Archibald D, Casari I, et al · · 2024 · cited 8× · PMID 38397018 · DOI 10.3390/ijms25042340 -
Advancing Brain Health Naturally: β-Caryophyllene and Xanthohumol as Neuroprotective Agents.
Ivanova S, Dzhakova Z, Todorova V, Boyuklieva R, et al · · 2025 · cited 1× · PMID 41011595 · DOI 10.3390/molecules30183702 -
Modulation of Microbiota-Derived Bile Acids Linked to Symptom Amelioration in Crohn's Disease: Insights From a Randomized Clinical Trial With Xanthohumol Supplementation.
Jamieson PE, Gu I, Reichart NJ, Maier CS, et al · · 2026 · PMID 42138225 · DOI 10.1002/mnfr.70501 -
Safety and Tolerability of Xanthohumol in Adults With Crohn's Disease: Results of a Triple‐Masked, Randomized, Placebo‐Controlled Phase 2 Trial
Bradley R, A. Staab C, E. Jamieson P, O. Langley B, et al · · 2026
Verify or expand the search:
- PubMed search for NCT04590508
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Xanthohumol
Trials testing the same drug.
- NCT06745102 — Hop Compounds on the Immune System in Overweight People · NA · recruiting
- NCT06286657 — Xanthohumol and Viral Infections (XL) · NA · recruiting
- NCT06225258 — Xanthohumol as an Adjuvant in the Treatment of Septic Shock · Phase 2 · recruiting
- NCT06286644 — Hop Compounds on the Immune System (VH) · NA · recruiting
- NCT03735420 — Xanthohumol Metabolism and Signature · Phase 1 · active not recruiting
Other recruiting trials for Crohn Disease
Currently open trials in the same condition.
- NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat · Phase 2 · recruiting
- NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) · Phase 4 · recruiting
- NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease · recruiting
- NCT07170462 — Cranberry and Gut Health in Crohn's Disease · EARLY_PHASE1 · recruiting
- NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease · Phase 2, PHASE3 · recruiting
Other National University of Natural Medicine trials
Trials by the same sponsor.
- NCT07498491 — Weighted Blanket Use for Adults With Chronic Pain · NA · not yet recruiting
- NCT07521904 — Naturopathic Approaches to Ulcerative Colitis · not yet recruiting
- NCT07151261 — Ashwagandha for Nighttime Waking · NA · active not recruiting
- NCT07022275 — Safety Evaluation of THC-Free Hemp Protein Isolate · NA · active not recruiting
- NCT06472791 — Centella Asiatica in Older Adults · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04590508 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National University of Natural Medicine
- Last refreshed: 18 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04590508.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing