Ketogenic Diet Supplement Shows Promise in Angelman Syndrome Trial
A small clinical trial has found a dietary supplement, designed to mimic a ketogenic diet, to be well-tolerated by youngsters with Angelman syndrome. The trial, involving 14 children aged 4 to 11, lasted 16 weeks and was conducted in four phases. While the supplement's efficacy could not be confirmed due to the small sample size, it was deemed safe and showed promising results in managing constipation.
The trial, led by Disruptive Nutrition, tested their ketogenic medical food formulation (KF). The supplement, containing ketones, was administered in powder form and was accepted and tolerated by 13 out of the 14 participants. Notably, the supplement demonstrated a consistent, gentle, and statistically significant improvement in constipation among the youngsters. Some families also reported reduced food-seeking behavior during the trial. Despite two reported adverse events - elevated triglycerides and low albumin levels - the supplement was generally well-tolerated. Further research, including a larger randomized placebo-controlled trial, is needed to confirm these findings and determine the supplement's efficacy.
Half of the participating families chose to continue using the ketogenic medical food formulation after the trial, indicating their satisfaction with the results. The company producing the supplement, Keto Vie, will likely build on these findings to further explore the potential benefits of their product for children with Angelman syndrome. However, a larger and longer randomized placebo-controlled trial is necessary to validate these initial findings and establish the supplement's safety and efficacy.
