Participants who adhered to early combined with energy restriction showed greater improvements in body mass index and fasting glucose after 3 months.
Early time-restricted eating (eTRE) combined with energy restriction (ER) resulted in a greater reduction in body fat percentage and BMI compared to late time-restricted eating (lTRE) with ER or ER alone.
Significant decreases in leptin levels were observed in the eTRE + ER group, indicating a stronger hormonal response than in the other groups.
Participants in the eTRE + ER group reported a significantly lower desire for food and reduced capacity to eat compared to those in the ER group.
Insulin levels, indexes, lipid profiles, adiponectin, ghrelin, visceral fat indexes, and liver enzymes showed similar changes across all groups, indicating comparable effectiveness in these areas.
Simplified
BACKGROUND: It remains unclear whether adding (TRE) to energy restriction (ER) offers additional cardiometabolic benefits, particularly in metabolic hormone regulation, and insulin sensitivity. This per-protocol analysis assessed whether early TRE (eTRE) or late TRE (lTRE), when combined with ER, additionally improves indexes, and cardiovascular and liver biomarkers compared to ER alone.
METHODS: We analysed per-protocol data of 90 participants, 31 from the eTRE with ER (eTRE + ER) group, 28 from the lTRE with ER (lTRE + ER) group and 31 from the ER group. As chronotype-adapted diets have already been shown to produce better outcomes than non-adapted ones and in line with real-life behaviour, randomisation was performed on the basis of the individuals' chronotype. Anthropometric and biochemical measurements for analysis were taken at baseline, and after first and third month of intervention. The primary outcome was mean change in body mass, while the secondary outcomes were mean changes in glycaemic markers (fasting glucose, fasting insulin), indexes of insulin resistance, cardiovascular and liver markers and metabolic hormones (adiponectin, ghrelin, leptin, leptin/ghrelin ratio). Additionally, participant's subjective appetite was also assessed at baseline and in third month of the intervention.
RESULTS: We confirmed that participants who adhered to eTRE + ER for 3 months showed greater improvements in % of fat mass, BMI, and fasting glucose compared to those in the lTRE + ER and/or ER group. These greater reductions in % of the fat mass and BMI were accompanied by more pronounced decreases in leptin levels, with eTRE + ER showing larger leptin reductions than lTRE + ER or ER. Additionally, the eTRE group showed a significantly greater decrease in desire for food and greater reduction in capacity to eat than ER. However, insulin levels, insulin resistance indexes, lipid profiles, adiponectin, ghrelin, visceral fat indexes, and liver enzymes showed similar changes across all groups.
CONCLUSIONS: This analysis showed that eTRE + ER is more effective weight management strategy, while eTRE + ER, lTRE + ER and ER are comparable effective on cardiovascular, liver and insulin resistance markers.
TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT05730231 (NCT05730231, registered on February 6, 2023).
Key numbers
-2.5%
Fat Mass Reduction
Mean change in fat mass after three months.
-46 ng/mL
Leptin Level Decrease
Mean change in leptin levels after three months.
-1.8
BMI Change
Mean change in BMI after three months.
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Declarations. Ethics approval and consent to participate: The present study was approved by the Slovenian National Medical Ethics Committee (No. 0120–557/2017/4; Ministry of Health, Republic of Slovenia). All participants completed an informed consent form. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.
