Prediabetes is a high-risk state for diabetes development, lifestyle modification is the cornerstone of diabetes prevention. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on glucose homeostasis and cardiometabolic risk factors in prediabetes over 6 months compared to usual health care.
Prediabetes is a high-risk state for diabetes development, lifestyle modification is the cornerstone of diabetes prevention. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. Preliminary evidence suggests that both TRE and the 5:2 diet have beneficial effects on glucose control in type 2 diabetes. No much is known about the effects and molecular mechanisms by TRE or the 5:2 diet improves glucose homeostasis in prediabetes. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on glucose homeostasis and cardiometabolic risk factors in prediabetes over 6 months compared to usual health care. All eligible participants will participate in an 8-week run-in phase in which they are fed the low-calorie-diet. Participants who pass the run-in phase will be randomly assigned 1:1:1 to one of the three study groups (TRE, the 5:2 diet and control groups). Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm) over 12 months. Participants in the 5:2 diet group will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days. Participants in the control group were instructed to receive usual health care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm).
Participants will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days.
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGChange in percent of time in range (glucose between 3.9-7.8mmol/L) over 6 months measured with continuous glucose monitoring.
Time frame: Baseline to months 6
Change in mean glucose levels
Time frame: Baseline and months 6
Change in glycemic variability
Time frame: Baseline and months 6
Change in percent of time below range
\<3.9 mmol/L
Time frame: Baseline and months 6
Change in percent of time above range
\>7.8 mmol/L
Time frame: Baseline and months 6
Change in resting metabolic rate
Resting metabolic rate will be assessed by indirect calorimetry.
Time frame: Baseline and months 6
Change in gut microbiome composition
Time frame: Baseline and months 6
Change in bile acid level
Time frame: Baseline and months 6
Change in body weight
Time frame: Baseline and months 6
Change in body composition
Body composition will be assessed by DEXA.
Time frame: Baseline and months 6
Change in waist circumference
Time frame: Baseline and months 6
Change in body mass index
Time frame: Baseline and months 6
Change in liver fat
Liver fat will be assessed by liver Fibroscan.
Time frame: Baseline and months 6
Change in visceral fat
Visceral fat will be assessed by abdominal CT scan.
Time frame: Baseline and months 6
Change in Systolic Blood pressure
Time frame: Baseline and months 6
Change in Diastolic Blood pressure
Time frame: Baseline and months 6
Change in blood lipids
Time frame: Baseline and months 6
Change in HbA1c
Time frame: Baseline and months 6
Change in insulin sensitivity
Time frame: Baseline and months 6
Change in β cell function
Time frame: Baseline and months 6
Change in pulse wave velocity (PWV)
Time frame: Baseline and months 6
Change in quality of life
Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)
Time frame: Baseline and months 6
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