Comparing the effectiveness of calorie restriction with and without time-restricted eating on the circadian regulation of metabolism – rationale and protocol of a three-arm randomised controlled trial in adults at risk of type 2 diabetes

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2025

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Chang, Y.J.
Turner, L.
Teong, X.T.
Zhao, L.
Variji, A.
Wittert, G.A.
Thompkins, S.
Vincent, A.D.
Grosser, L.
Young, M.J.

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Nutrition Research, 2025; 138:33-44

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You Jin Chang, Laurent Turner, Xiao Tong Teong, Lijun Zhao, Athena Variji, Gary A. Wittert, Sophia Thompkins, Andrew D. Vincent, Linda Grosser, Morag J. Young, Stephen Blake, Satchidananda Panda, Emily N.C. Manoogian, Siobhan Banks, Leonie K. Heilbronn, Amy T. Hutchison

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Abstract

Time-restricted eating (TRE) may extend the cardiometabolic health benefits of calorie re- striction (CR). However, few studies have compared its effect on the circadian regulation of glucose metabolism and the optimal time of day to initiate TRE is also unclear. This study aims to compare the effectiveness of CR with and without TRE on glucose tolerance in re- sponse to 3 identical meals consumed over the day. A parallel, single-blinded, 3-arm ran- domised controlled trial will be conducted in 114 adults, aged 35 to 75 years with a BMI ≥25.1 but < 45.0 kg/m2 , elevated waist circumference and fasting blood glucose ( ≥5.6 mmol/L), and who score ≥12 on the Australian Type 2 Diabetes Risk Assessment tool. Participants will be stratified by sex and fasting blood glucose ( ≤6.0 mmol/L; > 6.0 mmol/L) and then randomised (1:1:1) to CR (unrestricted meal timing), eCR (0800 to 1600) or dCR (1200-2000) for 8 weeks. The primary outcome is the change in the natural logarithm of the mean over 3 identical meals of the postprandial glucose area under the curve (AUC). The analysis will be performed us- ing a covariate adjusted linear regression of the differences in postprandial glucose log AUC at 8 weeks from baseline. This randomised clinical trial will be the first to delineate the benefits of CR alone or in combination with time restricted eating on postprandial glucose metabolism over the day in adults at increased risk of type 2 diabetes.

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Data source: supplementary materials, https://doi.org/10.1016/j.nutres.2025.03.009

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© 2025 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)

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