Adelaide Medical School, University of Adelaide, Adelaide, South Australia 5000, Australia; Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia 5000, Australia.
Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria 3000, Australia.
Contemp Clin Trials. 2024 Nov;146:107696. doi: 10.1016/j.cct.2024.107696. Epub 2024 Sep 17.
Time restricted eating (TRE) is a dietary strategy that may improve metabolic health. However, no studies have compared TRE with current practice (CP) in dietetics.
TRE will not be inferior to CP to improve glycaemic control in individuals at risk of type 2 diabetes (T2D).
This parallel group, randomised, non-inferiority, controlled trial randomised 247 participants by site and glycated haemoglobin (HbA1c) into TRE or CP (1:1) for 12 months. Participants were aged 35-70 years, with a body mass index (BMI) >25 but <45 kg/m, and score ≥15 on the Australian type 2 diabetes risk (AUSDRISK) assessment, without a diagnosis of T2D. Study visits were balanced between groups and all participants received five consultations at 0, 0.5, 1, 2 and 3 months. TRE followed a self-selected 9 h eating window (≥0600 and ≤1900), whereas CP followed Australian dietary guidelines.
The primary endpoint is the estimate of group mean difference (TRE vs CP) of HbA1c at 4 months in a covariate linear regression adjusting for stratification factors and sex. Secondary efficacy outcomes at 4 and 12 months are changes in fasting glucose, fasting insulin, HOMA-IR and nocturnal glucose by continuous glucose monitor incremental area under the curve and change in HbA1c at 12 months. Other endpoints are exploratory and will not be adjusted for multiplicity.
We will determine whether TRE is an alternate strategy to current practice in dietetics to improve glucose control.
NCT04762251; 21 Feb 2021.
限时进食（TRE）是一种可能改善代谢健康的饮食策略。然而，目前还没有研究将 TRE 与营养学中的现行实践（CP）进行比较。
TRE 在改善 2 型糖尿病（T2D）风险人群的血糖控制方面不会逊于 CP。
这项平行组、随机、非劣效性、对照试验，根据地点和糖化血红蛋白（HbA1c），将 247 名参与者按 TRE 或 CP（1:1）随机分组（1:1），进行为期 12 个月的治疗。参与者年龄在 35-70 岁之间，体重指数（BMI）>25 但<45kg/m，澳大利亚 2 型糖尿病风险评估（AUSDRISK）评分≥15 分，但无 T2D 诊断。组间研究访视平衡，所有参与者在 0、0.5、1、2 和 3 个月时接受 5 次咨询。TRE 遵循自我选择的 9 小时进食窗口（≥0600 至≤1900），而 CP 遵循澳大利亚膳食指南。
主要结局是调整分层因素和性别后，在协变量线性回归中，HbA1c 组间差异（TRE 与 CP）的估计值，在 4 个月时。次要疗效结局是在 4 个月和 12 个月时，通过连续血糖监测的空腹血糖、空腹胰岛素、HOMA-IR 和夜间血糖增量曲线下面积以及 12 个月时 HbA1c 的变化。其他结局是探索性的，不进行多重调整。
我们将确定 TRE 是否是改善血糖控制的一种替代现行营养学实践的策略。
NCT04762251；2021 年 2 月 21 日。
