A clinical trial is evaluating the safety and tolerability of a nutritional formulation containing the ketone beta-hydroxybutyrate BHB as a treatment to help control seizures in children with Angelman syndrome. Seizures that are resistant to medication are estimated to occur in more than three-quarters of people with Angelman syndrome AS. This diet involves eating very few carbohydrates sugars and starches and consuming more fats. Generally, cells in the body will preferentially use carbohydrates — particularly glucose — as an energy source. When carbohydrates are unavailable, the body will instead use fat for energy in a process called ketosis. This process, in turn, generates molecules called ketones, such as BHB. In the FANS trial, instead of going on a ketogenic diet, participants will be given a nutritional formulation that is directly supplemented with BHB. The idea is that directly consuming the ketones could produce similar benefits as a ketogenic diet, but be easier to manage. The trial is expected to enroll 15 participants with AS, ages 4 to Participants must have been on a consistent diet ketogenic or unmodified for at least three months. The study will last for 16 weeks.
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