PRG Single-arm Intervention Study and the Impact on Formula Intolerance in pALS
Andrea Charvet, PhD, is an Assistant Professor in the Department of Nutrition within the Dr. Kiran C. Patel College of Osteopathic Medicine. She is also the Registered Dietitian for the Cathy J. Husman ALS Center at the NSU Health Neuroscience Institute.
Tell me briefly about your recent grant-funded project.
My project entitled “Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding via G-tube and its Impact on Formula Intolerance in pALS” has been awarded a Nova Southeastern University 2024-2025 President’s Research Grant in the amount of $14,996. The primary focus of the proposed study is to evaluate whether oral intake of enteral nutrition (EN) formula preceding gastrostomy tube (G-tube) placement will impact tolerance upon placement and feeding via G-tube in patients with Amyotrophic Lateral Sclerosis (pALS).
This single–arm intervention study will utilize validated indicators along with clinical expertise to assess gastrointestinal symptoms of feeding intolerance before and after the intervention, with each patient serving as their own control. The study protocol is currently in the final stages of IRB review and patient recruitment is expected to begin early October.
Who is working with you on this project?
The collaborators in this project are from the Cathy J. Husman ALS Center: Gabriela Lopes, DNP, APRN, FNP-BC is the lead clinic coordinator; Eduardo Locatelli, MD, MPH is the medical director of the NSU Health Neuroscience Institute and Co-Director of the NSU Health Cathy J. Husman ALS Center; and Lauren Tabor Gray, PhD, CCC-SLP is an Assistant Professor at NSU and Co-Director of the NSU Health Cathy J. Husman ALS Center. The project also includes the participation of two undergraduate students in the Human Nutrition major program. Hannah Baumer, who is an undergraduate student at NSU pursuing a major degree in Human Nutrition and minor degrees in Pre-Health and Biology, was hired as a Research Assistant for the summer of 2024 and continues to work with me on this study as part of a Directed Individual Study course during the fall semester. The second student is expected to begin in the winter semester.
What opportunities and/or benefits does this grant bring to the NSU community?
This is the first PRG awarded to a faculty from the Nutrition Department in KPCOM. It serves as motivation for other faculty to pursue a similar funding mechanism and fosters research efforts aligning with NSU’s core values. I am sharing my experience and mentoring our department’s faculty on their research efforts. By involving students in this research project and including a grant-funded, paid Research Assistant position, we provide an opportunity for students to gain hands-on experience in research. The two undergraduate students will participate in data collection, data management, data analysis and scientific dissemination, and are encouraged to submit abstracts to scientific conferences.
The proposed work is the first to evaluate the impact of oral intake of EN formula preceding placement and feeding via G-tube on feeding intolerance. Given the importance of preventing weight loss and consequent malnutrition in individuals living with ALS, it is crucial to explore nutrition interventions to improve patient adherence to the prescribed feeding regimen. If the proposed therapeutic strategy is shown to be effective, it may be incorporated into clinical practice guidelines much needed in the management of G-tube usage to minimize malnutrition, increase survival time, and improve quality of life in pALS.
How does this project connect with your other work at NSU?
I am the course designer and course director for Principles of Medical Nutrition Therapy and Exploring Nutrition Research in the Bachelor of Science in Human Nutrition program. I use examples from both my clinical and my research experience in class with my students, and thrive to inspire them to be curious, ask questions, and pursue the answers. Twenty percent of my faculty position efforts are dedicated to my role as an ALS dietitian in the NSU Health Cathy J. Husman ALS Center. Through the multidisciplinary collaboration in the clinic, this study was conceptualized, and it is exciting to see it now come to life.
How has NSU helped you pursue and/or achieve personal and professional goals you have set for yourself? NSU resources used?
I always had a special interest in research and at NSU, I found the support to pursue my goals. In 2022, I approached my program director and asked for approval to be part of the NSU’s Grant Writing Mentorship program. I knew this was the best way to demonstrate my interest and receive the guidance to prepare my first grant application. I had an amazing research mentor and received tremendous support from the Division of Research and Economic Development. I also want to acknowledge the experienced researchers within the ALS clinic team, who have contributed with their perspectives and helped this project become reality. Lastly, the President’s Office and the Dr. Kiran C. Patel College of Osteopathic Medicine are the sponsors that are making this research study possible. I am extremely thankful for the continuous support I have received within NSU. But before I end this response, I must give a special thank you to the students that have worked with me in research efforts. You have helped me tremendously!
What advice do you have for other grant seekers at NSU?
All you need is a strong research question, and a pinch of perseverance. Stay focused, and don’t let obstacles stop you from reaching your goal. And don’t forget to continue to grow your professional network. Today you may be helping a colleague, but tomorrow you may be the one receiving help.
What is the next grant proposal or project on your agenda?
This study will generate preliminary data for an NIH R15 (or similar) grant submission, designed as a large multicenter randomized controlled intervention study.