The parent study, Xanthohumol Microbiome and Signature (XMaS) in Healthy Adults, is a RO1-funded, multiple principal investigator-led, FDA-approved Phase 1 clinical trial which aims to determine the safety and tolerability of a natural product made from xanthohumol (XN), a compound found in Humulus lupulus (hops), in healthy adults. In addition to assessing safety, collaborators on the trial from Oregon State University will also generate data on XN metabolites and its effects on biomarkers of inflammation and gut integrity. Additionally, collaborators at the Pacific Northwest National Laboratory will determine the effects of XN on the microbiota through sequencing and metabolomics profiling. Collectively, these data will be used as comparison data for a subsequent Phase 2 clinical trial in adults with Crohn?s Disease. The parent project is actively recruiting and enrolling participants, and will be doing so throughout 2020. The additional support of an administrative supplement will allow for a unique training opportunity for a post-doctoral, early-career Complementary and Integrative Health (CIH) clinician by: 1. Providing experience in the conduct of clinical trials through participation in the operational aspects of an active clinical trial while under the leadership and mentorship of an experienced team of researchers; 2. Supporting unique exposure and instruction on the translational scientific methods and techniques used in the laboratories of the multi-PI team; and 3. Encouraging skill development in biostatistics, presentation and publication. Trial participation will be initiated by training the candidate in clinical screenings and other visits, including: collection of survey data and biologic specimens, and adverse event reporting, as outlined in the trial protocol. The candidate will also gain exposure to specific assays included in the trial, such as microbiota sequencing and metabolomic profiling, through hands-on experience with rotations in each collaborative lab. Finally, skills development in biostatistics, presentation, and future publication will be conducted through training in systematic reviews, biostatistics coursework, performing an ancillary analysis of pre-existing data and participating in a systematic review writing team. While an initial year of participation is expected to produce measurable progress toward these aims, a second year of support would enable an extension of training into additional stages of the parent study.
Over the past several decades there has been an increased public use of complementary and integrative health (CIH) therapies, and a corresponding decrease in the number of clinicians pursuing clinical research careers, with very few pursuing clinical CIH research. One recognized barrier to entry into clinical research careers is the availability of mentorship and training in clinical research. This proposal leverages an active NIH-funded Phase 1 clinical trial of a natural product to provide a mentorship and training opportunity for a CIH practitioner in order to provide first hand experiences in the conduct of clinical research, allow for rotations through translational science laboratories and begin developing skills in biostatistics, research presentations and publications.
