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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., Trial Registration: NCT04762251; 21 Feb 2021., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)

Intermittent fasting (IF) is proposed as a viable alternative to moderate calorie restriction (CR) for weight loss and metabolic health, but few long term randomized trials have been conducted. This protocol paper describes the rationale and detailed protocol for DIRECT study (D aily versus I ntermittent R estriction of E nergy: C ontrolled T rial to Reduce Diabetes Risk), comparing long term effectiveness of IF versus CR on metabolic health in individuals who are at increased risk of developing type 2 diabetes. Anticipated 260 non-diabetic men and women aged 35–75 years, BMI 25−50 kg/m2 with score ≥12 on the Australian Diabetes Risk (AUSDRISK) calculator will be recruited into this open-label, multi-arm, parallel group sequential randomized controlled trial. Participants will be randomized to one of three groups for 18 months: IF (30% of energy needs on fast days), CR (70% of energy needs daily), or standard care (SC) group. All participants will visit the clinic fortnightly for weight assessments during active intervention phase (6 months), followed by a 12-month follow-up phase. IF and CR groups will receive further diet counselling by dietitian. Two primary outcomes are the changes in glycated haemoglobin (HbA1c) and postprandial glucose area under the curve (AUC) at week 24 post-randomization. Secondary outcomes include changes in weight, body composition via dual-energy X-ray absorptiometry, gastro-intestinal hormones, cardiovascular risk factors, and dietary record by a smartphone-based application. This study will provide substantial evidence as to whether IF is an effective nutrition intervention for glycaemic control in a population at risk of developing type 2 diabetes. [ABSTRACT FROM AUTHOR]

Introduction: Shift workers are at a greater risk for obesity-related conditions. The impacts of working at night presents a challenge for designing effective dietary weight-loss interventions for this population group. The Shifting Weight using Intermittent Fasting in night-shift workers (SWIFt) study is a world-first, randomized controlled trial that compares three weight-loss interventions. While the trial will evaluate the effectiveness of weight-loss outcomes, this mixed-methods evaluation aims to explore for who weight-loss outcomes are achieved and what factors (intervention features, individual, social, organisational and wider environmental) contribute to this., Methods: A convergent, mixed-methods evaluation design was chosen where quantitative and qualitative data collection occurs concurrently, analyzed separately, and converged in a final synthesis. Quantitative measures include participant engagement assessed via: dietary consult attendance, fulfillment of dietary goals, dietary energy intake, adherence to self-monitoring, and rates for participant drop-out; analyzed for frequency and proportions. Regression models will determine associations between engagement measures, participant characteristics (sex, age, ethnicity, occupation, shift type, night-shifts per week, years in night shift), intervention group, and weight change. Qualitative measures include semi-structured interviews with participants at baseline, 24-weeks, and 18-months, and fortnightly audio-diaries during the 24-week intervention. Interviews/diaries will be transcribed verbatim and analyzed using five-step thematic framework analysis in NVivo. Results from the quantitative and qualitative data will be integrated via table and narrative form to interrogate the validity of conclusions., Discussion: The SWIFt study is a world-first trial that compares the effectiveness of three weight-loss interventions for night shift workers. This mixed-methods evaluation aims to further explore the effectiveness of the interventions. The evaluation will determine for who the SWIFt interventions work best for, what intervention features are important, and what external factors need to be addressed to strengthen an approach. The findings will be useful for tailoring future scalability of dietary weight-loss interventions for night-shift workers. Clinical trial registration: This evaluation is based on the SWIFt trial registered with the Australian New Zealand Clinical Trials Registry [ACTRN 12619001035112]., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Davis, Bonham, Kleve, Dorrian and Huggins.)

Background and Aims: Substantial scientific evidence supports the effectiveness of a Mediterranean diet (MedDiet) in managing type 2 diabetes mellitus (T2DM). Potential benefits of time restricted feeding (TRF) in T2DM are unknown. The MedDietFast trial aims to investigate the efficacy of a MedDiet with or without TRF compared to standard care diet in managing T2DM., Methods and Results: 120 adults aged 20-75 with a body mass index (BMI) of 20-35 kg/m 2 and T2DM will be randomised in a 3-arm parallel design to follow an ad libitum MedDiet with or without 12-h TRF or the standard Australian Dietary Guidelines (ADG) for 24 weeks. All groups will receive dietary counselling fortnightly for 12 weeks and monthly thereafter. The primary outcome is changes in HbA1c from baseline to 12 and 24 weeks. Secondary outcomes include fasting blood glucose, insulin, blood lipids, weight loss, insulin resistance index (HOMA), Glucagon-like peptide 1 (GLP-1) and high-sensitivity C- reactive protein (hs-CRP). Data on medical history, anthropometry, wellbeing, MedDiet adherence and satiety will be measured at a private clinic via self-report questionnaires at baseline, 6, 12 and 24 weeks. Additionally, specimens (blood, urine and stool) will be collected at all time points for future omics analysis., Conclusion: The MedDietFast trial will examine the feasibility and effectiveness of a MedDiet with/without TRF in T2DM patients. Potential synergistic effects of a MedDiet with TRF will be evaluated. Future studies will generate microbiomic and metabolomic data for translation of findings into simple and effective management plans for T2DM patients., Trial Registration: Australia and New Zealand Clinical Trials Register, ACTRN12619000246189., Competing Interests: Declaration of competing interest All authors declare no competing interest., (Copyright © 2021 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)