NCT03802253.

Study name	Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial)
Methods	Randomised controlled trial
Participants	140 participants Ages Eligible for Study: 18 years to 70 years (adult, older adult) Sexes Eligible for Study: all Accepts Healthy volunteers: no Inclusion Criteria Aged ≥ 18 years Diagnosis of impaired glucose regulation (i.e. FG between 5.7‐6.9mmol/L) +/‐ impaired glucose tolerance (i.e. 2‐hour postprandial PG between 7.8‐11.1mmol/L) confirmed by latest OGTT results within 3 months prior to recruitment Body mass index (BMI)of 23.0 to 45.0 kg/m2;
Interventions	Arm Intervention/treatment Experimental: TRF Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction. Behavioural: Time Restricted Feeding(TRF) Participants will receive a diet of 1200‐1500 kcal/day and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm) in the first 6 months. 6 months later,Participants will receive a diet of 1200‐1500 kcal/day without a restriction of feeding time. Active comparator: RCD Participants in this group will focus on standard care with daily reduced calorie diet (RCD) Behavioural: Reduced Calorie Diet (RCD) Participants will receive a diet of 1200‐1500kcal/d and keep their usual eating pattern.
Outcomes	Primary Outcome Measures Changes in fasting blood glucose levels (mmol/L) [ Time Frame: 6 months and 12 months ] Change in insulin sensitivity [ Time Frame: 6 months and 12 months ] Insulin sensitivity will be assessed by HOMA‐IR Incidence of regression to normoglycaemia among the studied population [ Time Frame: 6 months and 12 months ] Secondary Outcome Measures Changes in body weight (Kilograms) [ Time Frame: 6 months and 12 months ] Changes in HbA1c levels (%) [ Time Frame: 6 months and 12 months ] Change in β cell function [ Time Frame: 6 months and 12 months ] β cell function will be assessed by HOMA‐β Changes in serum triglycerides levels (mmol/L) [ Time Frame: 6 months and 12 months ] Changes in serum low‐density lipoprotein levels (mmol/L) [ Time Frame: 6 months and 12 months ] Changes in serum total cholesterol levels(mmol/L) [ Time Frame: 6 months and 12 months ] Changes in waist circumference (cm) [ Time Frame: 6 months and 12 months ] Changes in abdominal circumference (cm) [ Time Frame: 6 months and 12 months ] Changes in diastolic pressure (DBP） [ Time Frame: 6 months and 12 months ] Changes in systolic pressure(SBP) [ Time Frame: 6 months and 12 months ] Incidence of DM [ Time Frame: 6 months and 12 months ] the incidence of DM among Chinese primary care patients with impaired fasting glucose (including isolated IFG or combined IFG / IGT)
Starting date	June 18, 2019
Contact information	liuchangqin@xmu.edu.cn
Notes	NCT03802253