Protocol for a 1-year randomised, controlled, parallel group, open-label trial on the effects and feasibility of time-restricted eating in individuals with type 2 diabetes- The Restricted Eating Time in the Treatment of Type 2 Diabetes (RESET2) trial.

Time-restricted eating (TRE) limits the time for food intake to typically 6-10 h/day without other dietary restrictions. The aim of the RESET2 (the REStricted Eating Time in the treatment of type 2 diabetes) trial is to investigate the effects on glycaemic control (HbA1c) and the feasibility of a 1-year TRE intervention in individuals with overweight/obesity and type 2 diabetes. The aim of the present paper is to describe the protocol for the RESET2 trial. RESET2 is a randomised, controlled, parallel-group, open-label trial. One hundred and sixty individuals with type 2 diabetes (HbA1c >53 mmol/mol (>7.0%)), and Body Mass Index ≥25 kg/m2 will be randomised to standard care plus TRE, or to standard care and habitual living. Both the intervention and control group will follow standard diabetes care including regular clinical visits 3-4 times/year. The intervention is divided into two periods: (1) a 3-month TRE period with a fixed eating window with a self-selected timing to obtain data from the participants' experiences with TRE and (2) a 9-month individually adjusted TRE period. Participants in the TRE group will be instructed to reduce their eating window by a minimum of 3 h/day compared to the habitual eating window and with an eating window of 8-10 h/day. Test days will be scheduled at baseline, after 3 months and after 1 year. The primary outcome is HbA1c (evaluated 3 months and 1 year after randomisation) and secondary outcomes are body weight, fat mass, continuous glucose monitoring derived time-in-range and use of antidiabetic medicine (evaluated 1 year after randomisation). Additionally, we will conduct a process evaluation to assess whether the TRE intervention functioned as hypothesised.

Termannsen AD ，Varming A ，Bjerre N ，Wodschow HZ ，Hansen GS ，Jensen NJ ，Persson F ，Bagger JI ，Panda S ，Finlayson G ，Ewers B ，Hansen DL ，Nørgaard K ，Rungby J ，Grunnet LG ，Blond MB ，Hempler NF ，Færch K ，Quist JS ... -  《-》

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 control

Charrouf R ，Parr EB ，Hutchison AT ，Flint SA ，Teong XT ，Wittert G ，Vincent AD ，Brennan L ，Devlin BL ，Hawley JA ，Heilbronn LK ... -  《-》

Comparing the effects of time-restricted eating on glycaemic control in people with type 2 diabetes with standard dietetic practice: A randomised controlled trial.

To test the efficacy of time-restricted eating (TRE) in comparison to dietitian-led individualised dietary guidance to improve HbA1c in people with Type 2 diabetes mellitus. In a parallel groups design, 51 adults (35-65 y) with Type 2 diabetes mellitus and overweight/obesity (HbA1c ≥6.5% (48 mmol/mol), BMI ≥25-≤40 kg/m2) commenced a six-month intervention. Following baseline, participants were randomised to TRE (1000-1900 h) or DIET (individualised dietetic guidance) with four consultations over four months. Changes in HbA1c (primary), body composition, and self-reported adherence (secondary) were analysed using linear mixed models. A non-inferiority margin of 0.3% (4 mmol/mol) HbA1c was set a priori. Forty-three participants (56 ± 8 y, BMI: 33 ± 5 kg/m2, HbA1c: 7.6 ± 0.8%) completed the intervention. HbA1c was reduced (P=0.002; TRE: -0.4% (-5 mmol/mol), DIET: -0.3% (-4 mmol/mol)) with no group or interaction effects; TRE was non-inferior to DIET (-0.11%, 95%CI: -0.50% to 0.28%). Body mass reduced in both groups (TRE: -1.7 kg; DIET: -1.2 kg) via ∼900 kJ/d spontaneous energy reduction (P<0.001). Self-reported adherence was higher in TRE versus DIET (P<0.001). When individualised dietary guidance is not available, effective, and/or suitable, TRE may be an alternative dietary strategy to improve glycaemic control in people with Type 2 diabetes mellitus.

Parr EB ，Radford BE ，Hall RC ，Steventon-Lorenzen N ，Flint SA ，Siviour Z ，Plessas C ，Halson SL ，Brennan L ，Kouw IWK ，Johnston RD ，Devlin BL ，Hawley JA ... -  《-》

Evaluating the effects of time-restricted eating on overweight and obese women with polycystic ovary syndrome: A randomized controlled trial study protocol.

Time-restricted eating (TRE) manages weight effectively, but choosing how long and what time window remain debatable. Although an 8:00 a.m. to 16:00 p.m. time frame is reported to show positive results in most weight loss trial, its safety and efficacy in overweight and obese women with polycystic ovary syndrome (PCOS) is uncertain. This randomized controlled trial is conducted to evaluate the safety and efficacy of TRE in specific populations. This study aims to assess the 6-month effects of TRE on weight change, metabolic improvement, reproductive recovery, and health-related quality of life in overweight and obese women with polycystic ovary syndrome (PCOS), compared to those who did not receive TRE. This randomized controlled trial will enroll 96 overweight and obese women with polycystic ovary syndrome (PCOS), who will be randomly assigned to either a TRE group (with an eating window from 8:00 a.m. to 16:00 p.m.) or a control group (without eating time restrictions), with 49 participants in each group. Evaluators and data analysts will remain blinded to group allocation throughout the study. The primary outcomes, including changes in weight and body mass index (BMI), will be assessed weekly. Secondary outcomes, encompassing alterations in sex hormones, metabolic parameters, body composition, sleep quality, quality of life, anxiety, and depression, will be evaluated monthly. Compliance and safety will be continuously monitored throughout the study. Additionally, a 6-month follow-up will be conducted at the end of the trial to assess the long-term effects of TRE. Statistical analysis will include the Anderson-Darling test for normality, T-test/Wilcoxon test based on distribution, mixed-effects models for assessing time/group effects, Cox model for time-to-event analysis, repeated ANOVA for change analysis, and sensitivity analysis. All tests will be conducted using appropriate software, with a significance level set at P<0.05. Missing data will be imputed. The purpose of this study protocol is to further evaluate the effects of TRE in overweight and obese women with PCOS through a randomized controlled trial (RCT). Findings from this study are expected to provide new dietary intervention strategies for overweight and obese PCOS participants. This study has received ethics approval from the Medical Ethics Committee of the University of South China (Number: NHHL027). Participants are included after signing informed consent. Results will be submitted for publication in peer-reviewed journals. Trail registration number: ChiCTR2400086815.

Liu H ，Shangguan F ，Liu F ，Guo Y ，Yu H ，Li H ，Su Y ，Li Z ... -  《-》

Randomized Controlled Feasibility Trial of Late 8-Hour Time-Restricted Eating for Adolescents With Type 2 Diabetes.

Hegedus E ，Vu MH ，Salvy SJ ，Bakhsh J ，Goran MI ，Raymond JK ，Espinoza JC ，Vidmar AP ... -  《Journal of the Academy of Nutrition and Dietetics》