Effect of time restricted eating versus current practice in dietetics on glycaemic control and cardio-metabolic outcomes in individuals at risk of developing type 2 diabetes: Protocol for a multi-centre, parallel group, non-inferiority, randomised controlled trial

被引：0

作者：

Charrouf, Rasha ^{[1
,2
]}

Parr, Evelyn B. ^{[3
]}

Hutchison, Amy T. ^{[1
,2
]}

Flint, Steve A. ^{[3
,4
]}

Teong, Xiao Tong ^{[1
,2
]}

Wittert, Gary ^{[1
,2
]}

Vincent, Andrew D.

Brennan, Leah ^{[5
]}

Devlin, Brooke L. ^{[6
]}

Hawley, John A. ^{[3
]}

Heilbronn, Leonie K. ^{[1
,2
]}

机构：

[1] Univ Adelaide, Adelaide Med Sch, Adelaide, SA 5000, Australia

[2] South Australian Hlth & Med Res Inst, Lifelong Hlth Theme, Adelaide, SA 5000, Australia

[3] Australian Catholic Univ, Mary MacKillop Inst Hlth Res, Exercise & Nutr Res Program, Melbourne, Vic 3000, Australia

[4] Univ Melbourne, Dept Med, Diabet Technol Res Grp, Melbourne, Vic 3065, Australia

[5] La Trobe Univ, Sch Psychol & Publ Hlth, Wodonga, Vic 3689, Australia

[6] Univ Queensland, Sch Human Movement & Nutr Sci, Brisbane, Qld 4072, Australia

来源：

CONTEMPORARY CLINICAL TRIALS | 2024年 / 146卷

关键词：

Time restricted eating (TRE); continuous; glucose monitoring; Current practice in dietetics; Obesity; Glycated haemoglobin (HbA1c); Psychological outcomes; QUALITY-OF-LIFE; INSTRUMENT; PREVENTION; AUSDRISK; HEALTH; IMPACT; MEN;

D O I：

10.1016/j.cct.2024.107696

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background: 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. Hypothesis: TRE will not be inferior to CP to improve glycaemic control in individuals at risk of type 2 diabetes (T2D). Methods: 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(2), 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. Outcomes: 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. Conclusions: We will determine whether TRE is an alternate strategy to current practice in dietetics to improve glucose control.

引用

页数：8