Clinical Trial

Durham, NC and Melbourne, Australia — Disruptive Nutrition, LLC the science-based leader in education and innovation for easy-to-access ketogenic products, and a subsidiary of Disruptive Enterprises, today announced its first clinical study in Australia to improve nutrition using ketogenic ingredients in children with Angelman syndrome. This is part of a broader clinical program using medical food formulations launched this past summer under the brand trumacro™ Nutrition.

“Exploration of ketogenic ingredients as nutritional intervention for the children living with Angelman syndrome represents an important facet of this clinical study,” said Dr. Donna Herber, Chief Science Officer, trumacro™ Nutrition. “This study represents our commitment to improving the lives of patients and their families through thoughtful approaches such as ketogenic technologies for nutritional support.”

The randomized, double-blind placebo-controlled crossover study will be managed in collaboration with the non-profit Neuroscience Trials Australia and supported through a grant from the Foundation for Angelman Syndrome Therapeutics Australia (FAST). The trial will assess the safety and tolerability of a nutritional formula containing exogenous ketones for use in dietary interventions for Angelman syndrome.

The study will be conducted by Disruptive Nutrition Pty Ltd – an Australian subsidiary of Disruptive Enterprises. Medical food formulations, trial design, and supportive funding will be provided by Disruptive Nutrition, which plans ultimately to launch trumacro™ Nutrition medical foods in Australia.

“I am delighted to be part of bringing a promising technology to the clinic in Australia. Our aim is to address unmet needs of children with Angelman syndrome and we believe this study will help us achieve that goal,” said Kathy Harrison, Director of Disruptive Nutrition Pty Ltd.

In 2016 a U.S. patent was issued entitled, “Ketone Supplements for the Treatment of Angelman Syndrome”, a project led by former USF Professor Edwin Weeber, USF Morsani College of Medicine Associate Professor Dominic D’Agostino, and USF Ph.D. alum Stephanie Ciarlone. The ketone supplementation has been found in research to alleviate seizures, cognitive disruption, motor coordination deficits and other symptoms in Angelman’s Syndrome. This technology is licensed to Disruptive Nutrition, LLC, which conducts research, develops intellectual property, and sell products under the trumacro™ Nutrition brand.

Disruptive Nutrition’s institutional research partners are FAST, Vanderbilt University, and the University of South Florida (USF). For more information about the study, please visit Clinicaltrials.gov (Identifier, NCT 03644693).

The study design is a 16-week, randomized, double blind, placebo-controlled crossover. Children ages 4-11 with genetically confirmed AS, and a variety of dietary backgrounds (standard, low glycemic index, ketogenic) are eligible to participate. The protocol consists of a two-week baseline period, followed by the first four-week intervention period, a four-week washout period, cross over to the second four-week intervention period, and ending with a two-week washout. During baseline and intervention periods, children are assessed in the clinic for neurodevelopment, medical, seizure and dietary history, blood metabolism, EEG, and mobility.

Disruptive Nutrition, LLC is the science-based leader in education and innovation for easy-to-access ketogenic products that boost overall nutrition and wellness for patients and consumers. The launch of the trumacro™ Nutrition brand further demonstrates a corporate commitment to improving lives through the therapeutic use of ketogenic (low-carb, high-fat) foods. trumacro™ Nutrition medical food formulations and meals target whole-body metabolism for optimal health and nutrition. For more information on trumacro, please visit www.trumacro.com