ACTRN12619000246189.

Study name	Mediterranean diet with or without intermittent fasting in type 2 diabetic patients: a randomized clinical trial
Methods	Randomised controlled trial
Participants	Diagnostic criteria: type 2 diabetes (previously diagnosed with HbA1c >7.0% [53 mmol/mol] and/or taking anti‐glycaemic medication) Age minimum: 20 years Age maximum: 75 years Gender: both males and females
Interventions	Arm 1 Intensive personalised dietary counselling based on a Mediterranean diet (low in saturated fat [<7% of total energy intake (TEI)] and high in fibre (> 40 g/day), consumed ad libitum and delivered by a nutritionist with minimum 5 years' experience. Arm 2 Intensive personalised dietary counselling based on a Mediterranean diet (low in saturated fat ([<7% of TEI and high in fibre (> 40 g/day]), consumed ad libitum accompanied by time restricted feeding (12 hours fasting every day).
Outcomes	Changes in HbA1c assessed by using serum essay analysis performed in a qualified laboratory.[Timepoint: Baseline, 3 months (primary time point) and 6 months after intervention commencement] Changes in CRP assessed by using serum essay analysis performed in a qualified laboratory.[Timepoint: Baseline, and at 3 and 6 months after intervention commencement] Changes in fasting plasma glucose assessed by using serum essay analysis performed in a qualified laboratory.[Timepoint: Baseline, and at 3 and 6 months after intervention commencement] Changes in HDL cholesterol assessed by using serum essay analysis performed in a qualified laboratory.[Timepoint: Baseline, and at 3 and 6 months after intervention commencement] Changes in LDL cholesterol assessed by using serum essay analysis performed in a qualified laboratory.[Timepoint: Baseline, and at 3 and 6 months after intervention commencement] Changes in plasma insulin concentrations assessed by using serum essay analysis performed in a qualified laboratory.[Timepoint: Baseline, and at 3 and 6 months after intervention commencement] Changes in systolic and diastolic blood pressure assessed using automated sphygmomanometry. [Timepoint: Baseline, and at 3 and 6 months after intervention commencement] Changes in total cholesterol assessed by using serum essay analysis performed in a qualified laboratory. [Timepoint: Baseline, and at 3 and 6 months after intervention commencement ] Changes in triglycerides assessed by using serum essay analysis performed in a qualified laboratory. [Timepoint: Baseline, and at 3 and 6 months after intervention commencement] Medication changes assessed using a medication record at each visit, asking specifically if there were any changes to the medications or the dose taken. [Timepoint: Baseline, and at 3 and 6 months after intervention commencement]
Starting date	01/04/2019
Contact information	C.Itsiopoulos@latrobe.edu.au
Notes