Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation: A Clinical Protocol (Preprint)

UNSTRUCTURED Abstract Background: Intermittent fasting (IF) interventions, such as time restricted eating (TRE) without calorie restriction, may offer diverse cardiometabolic health benefits including reducing inflammation. However, the underlying metabolic mechanisms are poorly understood. Methods: A pilot, prospective, single arm diet intervention study to evaluate ketone metabolism and immunoregulation of TRE (6-hr feeding/18-hr fast) without caloric restriction compared to a conventional dietary regimen (12-hr feeding/12-hr fast) in women. Ketone metabolism, immune profiles, and metabolic status will be assessed at baseline and after 3 days of TRE (6-hr feeding/18-hr fast). Discussion: This clinical protocol will evaluate whole-body ketone metabolism and immunoregulatory changes in women during TRE using state-of-the art stable isotope and immunophenotyping techniques. The study will determine the effects of a time-limited dietary pattern, without caloric restriction, on dynamic measures of immunity and metabolism. Trial Registration: The protocol for this study has been registered with the Clinical Trials.gov ID: NCT06169137, Date of registration: 12-11-2023. https://clinicaltrials.gov/study/NCT06169137