# CIH Practitioner Mentorship in Translational Clinical Research

> **NIH NIH R01** · OREGON STATE UNIVERSITY · 2020 · $139,600

## Abstract

Project Summary
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.

## Key facts

- **NIH application ID:** 10027107
- **Project number:** 3R01AT010271-02S1
- **Recipient organization:** OREGON STATE UNIVERSITY
- **Principal Investigator:** Ryan D Bradley
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $139,600
- **Award type:** 3
- **Project period:** 2018-09-21 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10027107

## Citation

> US National Institutes of Health, RePORTER application 10027107, CIH Practitioner Mentorship in Translational Clinical Research (3R01AT010271-02S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10027107. Licensed CC0.

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