# CIH Practitioner Mentorship in Translational Clinical Research

> **NIH NIH R01** · OREGON STATE UNIVERSITY · 2021 · $95,082

## Abstract

Project Summary
The parent study, Xanthohumol Microbiome and Signature (XMaS), is a RO1-funded, multiple principal
investigator-led, FDA-approved clinical trial that completed its Phase 1 clinical operation earlier this year. The
Phase 1 trial aimed 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, and 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 the Phase 2 clinical trial in Crohn’s Disease, which began recruitment on September
16th, 2020. The additional support of a second-year administrative supplement for Dr. Langley will allow for
continued training opportunity for a post-doctoral, early-career Complementary and Integrative Health (CIH)
clinician by: 1. Building upon 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. Gaining exposure and instruction on the translational scientific methods and techniques used in
the collaborative laboratories of the multi-PI team; 3. Encouraging skill development in technical writing,
presentation, publication, and statistical analysis; and 4. Developing skills in biostatistics, epidemiology, and
clinical trial methodology through didactic coursework. 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 by finalizing the scoping review currently in development, biostatistics and epidemiology coursework,
continuing manuscript development, and performing secondary data analysis under the mentorship of our
resident biostatistician. With the successful completion of his initial year of training, a second year of support for
Dr. Langley will provide valuable experience as he becomes more competitive for future training awards in clinical
and translational research.

## Key facts

- **NIH application ID:** 10273070
- **Project number:** 3R01AT010271-03S1
- **Recipient organization:** OREGON STATE UNIVERSITY
- **Principal Investigator:** Ryan D Bradley
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $95,082
- **Award type:** 3
- **Project period:** 2018-09-21 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10273070

## Citation

> US National Institutes of Health, RePORTER application 10273070, CIH Practitioner Mentorship in Translational Clinical Research (3R01AT010271-03S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10273070. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*