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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Jul 23, 2025
Date Accepted: Jan 15, 2026

The final, peer-reviewed published version of this preprint can be found here:

Effects of Time-Restricted Eating on Ketone Metabolism and Immunoregulation in Premenopausal Women: Protocol for a Pilot, Prospective, Single-Arm Dietary Intervention Study

Thota GP, Macheret NA, Glaros SB, Kacker IN, Cantor SL, Mabundo L, Malandrino N, Chen KY, Courville AB, Turner S, Yang S, Krenek A, Recupero TC, Klein RJ, Han K, Puchalska P, Crawford P, Sack MN, Chung ST

Effects of Time-Restricted Eating on Ketone Metabolism and Immunoregulation in Premenopausal Women: Protocol for a Pilot, Prospective, Single-Arm Dietary Intervention Study

JMIR Res Protoc 2026;15:e81063

DOI: 10.2196/81063

PMID: 41791103

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

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

  • Geethika P Thota; 
  • Natalie A Macheret; 
  • Sophia B Glaros; 
  • Ila N Kacker; 
  • Samson L Cantor; 
  • Lilian Mabundo; 
  • Noemi Malandrino; 
  • Kong Y Chen; 
  • Amber B Courville; 
  • Sara Turner; 
  • Shanna Yang; 
  • Andrea Krenek; 
  • Thomas C Recupero; 
  • Rachael J Klein; 
  • Kim Han; 
  • Patrycja Puchalska; 
  • Peter Crawford; 
  • Michael N Sack; 
  • Stephanie T Chung

ABSTRACT

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


 Citation

Please cite as:

Thota GP, Macheret NA, Glaros SB, Kacker IN, Cantor SL, Mabundo L, Malandrino N, Chen KY, Courville AB, Turner S, Yang S, Krenek A, Recupero TC, Klein RJ, Han K, Puchalska P, Crawford P, Sack MN, Chung ST

Effects of Time-Restricted Eating on Ketone Metabolism and Immunoregulation in Premenopausal Women: Protocol for a Pilot, Prospective, Single-Arm Dietary Intervention Study

JMIR Res Protoc 2026;15:e81063

DOI: 10.2196/81063

PMID: 41791103

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