The rationale and design of a Mediterranean diet accompanied by time restricted feeding to optimise the management of type 2 diabetes: The MedDietFast randomised controlled trial.

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/m2 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.