Disruptive Nutrition, the keto-medical foods company, a subsidiary of Disruptive Enterprises, today announced the first patient enrolled in a clinical research study that it is being conducted in collaboration with leading investigators at Monroe Carell Jr. Children’s Hospital at Vanderbilt and the University of South Florida (USF). The study was funded by a grant from the Foundation for Angelman Syndrome Therapeutics (FAST). Angelman Syndrome is a genetic disorder that mainly affects the nervous system. Symptoms include a small head and a specific facial appearance, severe intellectual disability, developmental disability, speaking problems, balance and movement problems, seizures, and sleep problems. Children usually have a happy personality and have a particular interest in water. The symptoms generally become noticeable by one year of age. This randomized, double-blind placebo controlled, crossover study will assess safety and tolerability of a nutritional formula containing exogeneous ketones for use in dietary interventions for Angelman syndrome.
“Initiation of this nutritional intervention represents a significant milestone for patients with Angelman syndrome, their caregivers and physicians,” said Donna Herber, PhD, chief science officer, Disruptive Enterprises. “This study demonstrates our continued commitment to improving societal wellbeing and scientific advancement of ketogenic technologies for nutritional support of Angelman syndrome and other medical conditions that would potentially benefit from a ketogenic diet. We are grateful for the families that will participate in this study and for our study partners at FAST, Vanderbilt and USF that are working with us on the scientific advancement of readily accessible and lifestyle appropriate ketogenic technologies.”
“For more than 10 years, FAST has been committed to the care of patients and families with Angelman syndrome with the goal of bringing practical treatment into current medical practice as quickly as possible,” said Allyson Berent, chief science officer, FAST. “The dedication shown by Disruptive and our academic study partners at Vanderbilt and USF on this innovative nutritional intervention has the potential to be a paradigm shift in the management of Angelman syndrome.”
“There is a significant unmet need for targeted nutritional support of patients with Angelman syndrome that could serve as adjunct therapy for the management of refractory seizures,” said Jessica Duis, MD, MS, Assistant Professor of Pediatrics at Children’s Hospital at Vanderbilt. “We expect that this study will generate important insights about ketogenic diets and how they can benefit Angelman syndrome patients. We look forward to continuing our partnership with Disruptive Nutrition, FAST and other academic centers to educate and advance the utilization of exogenous ketones in dietary interventions for a variety of patient populations.”“We are excited to support this innovative clinical research study on a nutritional formulation containing exogenous ketones that would potentially transform the management of Angelman syndrome,” said Ed Weeber Professor, Molecular Pharmacology and Physiology, College of Medicine at the University of South Florida. For more information about the study, please visit Clinicaltrials.gov (Identifier, NCT 03644693) or see the link.