Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 23, 2025
Date Accepted: Jan 15, 2026
Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation: A Clinical Protocol
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.
Objective:
This study is designed 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.
Methods:
A pilot, prospective, single arm dietary intervention study in premenopausal women classified as lean and obese, with intraindividual and stratified comparisons. Ketone turnover, immunological responses and metabolic profiles will be compared between a conventional dietary regimen (12-hr feeding/12-hr fast) at admission and after 3 days of TRE (6-hr feeding/18-hr fast).
Results:
The trial commenced in August 2024. As of the time of manuscript submission, participant enrollment is ongoing. The integrated analyses will be reported once the data analysis is completed.
Conclusions:
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. Clinical Trial: 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
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