Journal article
Xanthohumol Microbiome and Signature in Healthy Adults (the XMaS Trial): Safety and Tolerability Results of a Phase I Triple-Masked, Placebo-Controlled Clinical Trial
Molecular nutrition & food research, Vol.65(8), pp.1-9
04/2021
PMID: 33629812
Metrics
22 Record Views
UN Sustainable Development Goals (SDGs)
This output has contributed to the advancement of the following goals:
Source: InCites
Abstract
Scope
Xanthohumol, a prenylflavonoid from hops, has been extensively studied preclinically but has undergone limited research in human subjects. A triple-masked, placebo-controlled phase I clinical trial was conducted to examine the safety and tolerability of xanthohumol.
Methods and Results
Thirty healthy volunteers were randomized to 24 mg day−1 xanthohumol (99.8% pure) or placebo for eight weeks. Comprehensive metabolic panels, complete blood counts, body weight, vital signs, and health-related quality of life questionnaires were assessed every two weeks. Participants were interviewed for adverse events (AEs) throughout the trial. Thirteen of 14 (93%) and 14 of 16 (88%) participants completed the trial in the placebo and xanthohumol groups, respectively. There were no withdrawals due to AEs. There were no clinically relevant, between-group differences in laboratory biomarkers, body weight, vital signs, or health-related quality of life. There were no severe or FDA-defined serious AEs, but non-serious AEs are documented in both the placebo (n = 42) and xanthohumol (n = 58) groups.
Conclusion
Over an eight-week period, 24 mg daily xanthohumol was safe and well-tolerated by healthy adults.
Details
- Title
- Xanthohumol Microbiome and Signature in Healthy Adults (the XMaS Trial): Safety and Tolerability Results of a Phase I Triple-Masked, Placebo-Controlled Clinical Trial
- Creators
- Blake O. Langley - National University of Natural MedicineJennifer Joan Ryan - National University of Natural MedicineDouglas Hanes - National University of Natural MedicineJohn Phipps - National University of Natural MedicineEmily Stack - National University of Natural MedicineThomas O. Metz - Pacific Northwest National LaboratoryJ. Frederik Stevens - Linus Pauling InstituteRyan Bradley - National University of Natural Medicine
- Publication Details
- Molecular nutrition & food research, Vol.65(8), pp.1-9
- Publisher
- Wiley
- Number of pages
- 9
- Grant note
- R01 AT010271; R01 AT010271-02S1 / National Institutes of Health National Center for Complementary and Integrative Health DE-AC05-76RL01830 / U.S. Department of Energy; United States Department of Energy (DOE)
- Identifiers
- 991013036330302368
- Copyright
- © 2021 Wiley-VCH GmbH
- Academic Unit
- National Centre for Naturopathic Medicine
- Language
- English
- Resource Type
- Journal article