NCT03689608.

Study name	Daily vs Intermittent Restriction of Energy: Controlled Trial to reduce diabetes risk (DIRECT)
Methods	Randomised controlled trial
Participants	252 participants Ages Eligible for Study: 35 years to 75 years (adult, older adult) Sexes Eligible for Study: all Accepts Healthy volunteers: yes Criteria Inclusion Criteria Weight‐stable (< 5 % fluctuation in their body weight for past 6‐months at study entry) Score 12 or greater on the AUSDRISK calculator HbA1c <48 mmol/L (measured at screening)
Interventions	Arm Intervention/treatment Experimental: Intermittent Fasting (IF) 3 days fasting per week Other: Intermittent Fasting (IF) Participants will fast 3 days per week. In fasting days, meal replacements at 30% of daily energy requirements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment. Experimental: Daily Restriction (DR) daily energy restriction Other: Daily Restriction (DR) Participants are instructed to restrict energy intake by 30% of daily energy requirements. Meal replacements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment. standard care (SC) usual care Other: standard care (SC) Participants will receive current practice guidelines in a static information format, will not take part in any counselling or receive meal replacements.
Outcomes	Primary Outcome Measures : Glycaemia [ Time Frame: 6 months ] Change in postprandial glucose HbA1c [ Time Frame: 6 months ] Change in HbA1c Secondary Outcome Measures: Body weight [ Time Frame: 2 months, 6 months, 18 months ] changes in body weight in kilograms Body composition [ Time Frame: 6 months, 18 months ] changes in body fat mass in kilograms waist and hip circumference [ Time Frame: 2 months, 6 months, 18 months ] changes in waist and hip circumference blood lipids [ Time Frame: 2 months, 6 months, 18 months ] changes in blood lipid profile (total cholesterol, HDL‐, LDL‐cholesterol and triglycerides) adherence to intervention [ Time Frame: 2 months, 6 months, 18 months ] assessed by diet records HbA1c [ Time Frame: 2 months, 18 months ] Change in HbA1c blood pressure [ Time Frame: 2 months, 6 months, 18 months ] Changes in systolic blood pressure and diastolic blood pressure Postprandial glucose [ Time Frame: 18 months ] Change in postprandial glucose
Starting date	September 26, 2018
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Notes	NCT03689608