PMID- 33629812
OWN - NLM
STAT- MEDLINE
DCOM- 20211119
LR  - 20240402
IS  - 1613-4133 (Electronic)
IS  - 1613-4125 (Print)
IS  - 1613-4125 (Linking)
VI  - 65
IP  - 8
DP  - 2021 Apr
TI  - Xanthohumol Microbiome and Signature in Healthy Adults (the XMaS Trial): Safety 
      and Tolerability Results of a Phase I Triple-Masked, Placebo-Controlled Clinical 
      Trial.
PG  - e2001170
LID - 10.1002/mnfr.202001170 [doi]
AB  - 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.
CI  - (c) 2021 Wiley-VCH GmbH.
FAU - Langley, Blake O
AU  - Langley BO
AUID- ORCID: 0000-0002-8942-1981
AD  - Helfgott Research Institute, National University of Natural Medicine, Portland, 
      Oregon, USA.
FAU - Ryan, Jennifer Joan
AU  - Ryan JJ
AUID- ORCID: 0000-0001-6324-9186
AD  - Helfgott Research Institute, National University of Natural Medicine, Portland, 
      Oregon, USA.
FAU - Hanes, Douglas
AU  - Hanes D
AD  - Helfgott Research Institute, National University of Natural Medicine, Portland, 
      Oregon, USA.
FAU - Phipps, John
AU  - Phipps J
AUID- ORCID: 0000-0001-6831-0564
AD  - Helfgott Research Institute, National University of Natural Medicine, Portland, 
      Oregon, USA.
FAU - Stack, Emily
AU  - Stack E
AD  - Helfgott Research Institute, National University of Natural Medicine, Portland, 
      Oregon, USA.
FAU - Metz, Thomas O
AU  - Metz TO
AUID- ORCID: 0000-0001-6049-3968
AD  - Biological Sciences Division, Pacific Northwest National Laboratory, Richland, 
      Washington, USA.
FAU - Stevens, J Frederik
AU  - Stevens JF
AUID- ORCID: 0000-0002-6348-9347
AD  - College of Pharmacy and the Linus Pauling Institute, Oregon State University, 
      Corvallis, Oregon, USA.
FAU - Bradley, Ryan
AU  - Bradley R
AUID- ORCID: 0000-0002-8073-3671
AD  - Helfgott Research Institute, National University of Natural Medicine, Portland, 
      Oregon, USA.
AD  - Herbert Wertheim School of Public Health and Human Longevity Science, San Diego, 
      University of California, La Jolla, California, USA.
LA  - eng
GR  - K24 AT011568/AT/NCCIH NIH HHS/United States
GR  - R01 AT010271/AT/NCCIH NIH HHS/United States
GR  - R90 AT008924/AT/NCCIH NIH HHS/United States
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20210311
PL  - Germany
TA  - Mol Nutr Food Res
JT  - Molecular nutrition & food research
JID - 101231818
RN  - 0 (Biomarkers)
RN  - 0 (Flavonoids)
RN  - 0 (Placebos)
RN  - 0 (Propiophenones)
RN  - T4467YT1NT (xanthohumol)
SB  - IM
MH  - Adult
MH  - Biomarkers/blood
MH  - Body Weight/drug effects
MH  - Female
MH  - Flavonoids/*adverse effects/*pharmacology
MH  - Healthy Volunteers
MH  - Humans
MH  - Male
MH  - Placebos
MH  - Propiophenones/*adverse effects/*pharmacology
MH  - Quality of Life
PMC - PMC8221389
MID - NIHMS1707595
OTO - NOTNLM
OT  - clinical trial
OT  - phase I
OT  - safety
OT  - tolerability
OT  - xanthohumol
COIS- Potential Conflicts of Interest: No conflicts of interest to report.
EDAT- 2021/02/26 06:00
MHDA- 2021/11/20 06:00
PMCR- 2022/04/01
CRDT- 2021/02/25 08:40
PHST- 2021/01/21 00:00 [revised]
PHST- 2020/12/09 00:00 [received]
PHST- 2021/02/26 06:00 [pubmed]
PHST- 2021/11/20 06:00 [medline]
PHST- 2021/02/25 08:40 [entrez]
PHST- 2022/04/01 00:00 [pmc-release]
AID - 10.1002/mnfr.202001170 [doi]
PST - ppublish
SO  - Mol Nutr Food Res. 2021 Apr;65(8):e2001170. doi: 10.1002/mnfr.202001170. Epub 
      2021 Mar 11.