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Safety and Tolerability of Xanthohumol in Adults With Crohn's Disease: Results of a Triple-Masked, Randomized, Placebo-Controlled Phase 2 Trial.

  • 2026-03
  • Molecular nutrition & food research 70(6)
    • Ryan Bradley
    • Carina A Staab
    • Paige E Jamieson
    • Blake O Langley
    • Thomas O Metz
    • Jan F Stevens

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 20
Population
20 adults with unremitted Crohn's disease (CD)
Methods
randomized, triple-masked, placebo-controlled phase 2 trial, 24 mg/day XN or placebo for 8 weeks
Blinding
Double-blind
Duration
8 weeks
Funding
Unclear
  • Rigorous Journal
Xanthohumol (XN), a flavonoid from hops (Humulus lupulus), exhibits mucosal anti-inflammatory, antioxidant, and microbiome-modulating effects, making it a candidate therapeutic for inflammatory bowel disease. We assessed the safety and tolerability of XN in adults with Crohn's disease (CD) over 8 weeks. In this randomized, triple-masked, placebo-controlled phase 2 trial, 20 adults with unremitted CD received either 24 mg/day XN or placebo for 8 weeks. Primary outcomes included clinical laboratory toxicology parameters, vital signs and adverse events (AEs). Disease activity was screened and assessed using the Crohn's Disease Activity Index (CDAI). XN was well tolerated, with adherence exceeding 95%. Neither halting nor stopping criteria were met, and all laboratory elevations were minor and transient in both groups. There were no attributable serious AEs in either group, and all moderate AEs were short-term and self-resolving. Between-group comparisons demonstrated differences for changes in BMI and gamma-glutamyltransferase (GGT), favoring XN: BMI: -0.67 (0.0, 1.3), p = 0.04 and GGT: -4.8 U/L, 95% CI 0.8-8.8, p = 0.02, which may reflect beneficial effects on hepatic and metabolic health in CD. XN at 24 mg/day was safe and well tolerated in adults with active CD, supporting further research in inflammatory bowel disease.

Research Insights

  • Hops→Reduced Body Mass Index

    Between-group comparisons demonstrated differences for changes in BMI and gamma-glutamyltransferase (GGT), favoring XN: BMI: -0.67 (0.0, 1.3), p = 0.04 and GGT: -4.8 U/L, 95% CI 0.8-8.8, p = 0.02, which may reflect beneficial effects on hepatic and metabolic health in CD.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    24 mg/day
  • Hops→Reduced Gamma-Glutamyl Transferase Levels

    Between-group comparisons demonstrated differences for changes in BMI and gamma-glutamyltransferase (GGT), favoring XN: BMI: -0.67 (0.0, 1.3), p = 0.04 and GGT: -4.8 U/L, 95% CI 0.8-8.8, p = 0.02, which may reflect beneficial effects on hepatic and metabolic health in CD.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    24 mg/day
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