Blake O Langley1, Jennifer Joan Ryan1, Douglas Hanes1, John Phipps1, Emily Stack1, Thomas O Metz2, J Frederik Stevens3, Ryan Bradley1,4. 1. Helfgott Research Institute, National University of Natural Medicine, Portland, Oregon, USA. 2. Biological Sciences Division, Pacific Northwest National Laboratory, Richland, Washington, USA. 3. College of Pharmacy and the Linus Pauling Institute, Oregon State University, Corvallis, Oregon, USA. 4. Herbert Wertheim School of Public Health and Human Longevity Science, San Diego, University of California, La Jolla, California, USA.
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.
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.
Authors: Richard B van Breemen; Yang Yuan; Suzanne Banuvar; Lee P Shulman; Xi Qiu; René F Ramos Alvarenga; Shao-Nong Chen; Birgit M Dietz; Judy L Bolton; Guido F Pauli; Elizabeth Krause; Marlos Viana; Dejan Nikolic Journal: Mol Nutr Food Res Date: 2014-09-16 Impact factor: 5.914
Authors: Annalouise O'Connor; Veera Konda; Ralph L Reed; J Mark Christensen; Jan F Stevens; Nikhat Contractor Journal: Mol Nutr Food Res Date: 2018-02-26 Impact factor: 5.914
Authors: Franziska Ferk; Miroslav Mišík; Armen Nersesyan; Christoph Pichler; Walter Jäger; Thomas Szekeres; Rodrig Marculescu; Henrik E Poulsen; Trine Henriksen; Roberto Bono; Valeria Romanazzi; Halh Al-Serori; Martin Biendl; Karl-Heinz Wagner; Michael Kundi; Siegfried Knasmüller Journal: Mol Nutr Food Res Date: 2016-03-17 Impact factor: 5.914