Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism andImmunoregulation

National Institute Of Diabetes And Digestive And Kidney Diseases

Investigators

Abstract

The protocol was IRB approved in November 2023 but protocol site activation occurred in September 2024 due to unanticipated delays in supply chain for acquiring stable isotopes of beta hydroxybutyrate. Recruitment was started and has been successful with expected enrollment rates and no unanticipated events or serious protocol deviations. There are no new reports in the literature that would affect the conduct of this study and stable isotope administration continues per protocol without incident. As of August 30, 2025, we have recruited 50% of total study numbers and the protocol is expected to continue within the expected timeframe.