Progress 06/01/24 to 05/31/25
Outputs
Target Audience:This project has provided research/experiential learning opportunities in FDA-IND preparation and application process, IRB preparation, regulatory and approval process, clinicaltrials.gov registration, SOP establishment and team staff training to 2 postdoctoral research associates and 1 medical student. Changes/Problems:The major changes of this project include: A change in the ginger supplement: As suggested by FDA and confirmed with the supplement vendor, we will use 5% gingerols ginger extract instead of using 20% gingerols-enriched ginger extract for this study. With the commitment of the study supplement vendor, we have provided FDA all Certificate of Analysis (COA) for raw material of ginger extract, empty capsules, and finished supplement products. Our final ginger supplement (5% gingerol) for an 8-week intervention has been reported in asthma patients in the Zhang 2022 study showing no clinical concern (Zhang 2022, doi: 10.1021/acs.jafc.2c03150). Such a change will have no significant impact on either the overall goal of the project or the rate of expenditure. This change has been approved by the TTUHSC IRB full board meeting. Problems: Although we had encountered an unexpected delay due to FDA-IND/IRB process, our experienced research team, especially study physicians, are proactively assisting in participant enrollment. What opportunities for training and professional development has the project provided?Through preclinical studies, we provided training to two senior research associates in the conceptual aspects of research into bioactive compounds in pain conditions. How have the results been disseminated to communities of interest?Due to the delays mentioned above and because this is the first year of the recruitment phase, we don't have any results to disseminate to communities of interest. However, we have published the following two papers which are in the field of current project. Shen CL, Hassan T, Presto P, Payberah D, Devega R, Wakefield S, Dunn DM, Neugebauer V. Novel insights into dietary bioactive compounds and major depressive disorders: evidence from animal studies and future perspectives. Journal of Nutrition, 2025 Apr 22:S0022-3166(25)00190-7. doi: 10.1016/j.tjnut.2025.04.006. Online ahead of print. Shen CL, Santos JM, Elmassry MM, Chen F, Ji G, Presto P, Kiritoshi T, Liu X, Neugebauer V. Crosstalk among gut microbiota, fecal metabolites, and amygdala neuropathology genes after ginger polyphenols administration in female rats with neuropathic pain: evidence for microbiota-gut-brain connection. Nutrients. 2025 Apr 25;17(9):1444. doi: 10.3390/nu17091444. What do you plan to do during the next reporting period to accomplish the goals?We plan to finish 50% subject recruitment (targeted number 40 subjects) and also complete study intervention (placebo vs. ginger) for 8 weeks. We will have data from the pain survey and fMRI imaging (SA 3) collected at the baseline and after 8 weeks intervention. The specimen including blood and stools will be archived and stored at -80°C prior to laboratory analysis. The PD/Shen will have weekly meetings with study coordinator, laboratory team member, and any involved personnel to discuss study progress and provide timely feedback.
Impacts
What was accomplished under these goals?
During the first 2 months, we have prepared and submitted our study protocol for an IRB approval and we were advised to check with the FDA whether or not an Investigational New Drug (IND) was required. The following 4 months were spent with communications among the FDA, ginger supplement vendor, and research team for IND approval. Then, it took another 2 months for our IRB approval. During that time, we trained our study team, set up all laboratory-related tasks and workflow, arranged Material Transfer Agreement (MTA) between supplement vendor and TTUHSC, and established SOP for the proposed work. Currently, we are taking the following approaches to promote participant enrollment from Lubbock and surrounding areas in Texas: TTUHSC Lubbock Clinics of our study physicians by flyers with QR code, Grace Clinic, TTUHSC Lubbock electronic medical records including advertisements through newspaper (Lubbock Avalanche-Journal), senior newsletters (Lubbock Senior Link Magazine), listservs, as well as direct person-to-person solicitation in the TTUHSC Lubbock clinics, health fairs (Healthwise Expo), flyers, and campus announcements. We have completed a study protocol manuscript (title: Ginger and the microbiota-gut-brain connection in sciatic pain individuals: study protocol for a double-blinded placebo-controlled randomized trial) for publication. Although we have encountered an unexpected delay due to FDA-IND/IRB process, our experienced research team, especially study physicians, are proactively assisting in participant enrollment, and we are now ready to perform the proposed work.
Publications
- Type:
Peer Reviewed Journal Articles
Status:
Published
Year Published:
2025
Citation:
Shen CL, Hassan T, Presto P, Payberah D, Devega R, Wakefield S, Dunn DM, Neugebauer V. Novel insights into dietary bioactive compounds and major depressive disorders: evidence from animal studies and future perspectives. Journal of Nutrition, 2025 Apr 22:S0022-3166(25)00190-7.
- Type:
Peer Reviewed Journal Articles
Status:
Published
Year Published:
2025
Citation:
Shen CL, Santos JM, Elmassry MM, Chen F, Ji G, Presto P, Kiritoshi T, Liu X, Neugebauer V. Crosstalk among gut microbiota, fecal metabolites, and amygdala neuropathology genes after ginger polyphenols administration in female rats with neuropathic pain: evidence for microbiota-gut-brain connection. Nutrients. 2025 Apr 25;17(9):1444.
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