Intermittent Eating on Glucose Homeostasis in Prediabetes
- Conditions
- PreDiabetesObesity
- Interventions
- Behavioral: Time-restricted eating
- Registration Number
- NCT05717387
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 87
- Men or women aged 18-75 years;
- Prediabetes;
- Body mass index (BMI)of 28.0 to 45.0 kg/m2;
- History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
- Diagnosis of type 1 and type 2 diabetes;
- History of malignant tumors;
- Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR<30 ml/min/1.73 m2);
- History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
- History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
- History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
- Being a smoker or having been a smoker in the 3 months prior to their screening visit;
- Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
- Currently participating in weight loss programs;
- Women who are pregnant or plan to become pregnant;
- Patients who cannot be followed for 24 months (due to a health situation or migration);
- Patients who are unwilling or unable to give informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Time-restricted eating Time-restricted eating Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm)
- Primary Outcome Measures
Name Time Method Change in percent of time in range (glucose between 3.9-7.8mmol/L) over 6 months measured with continuous glucose monitoring. Baseline to months 6
- Secondary Outcome Measures
Name Time Method Change in body composition Baseline and months 6 Body composition will be assessed by DEXA.
Change in bile acid level Baseline and months 6 Change in body mass index Baseline and months 6 Change in blood lipids Baseline and months 6 Change in mean glucose levels Baseline and months 6 Change in percent of time above range Baseline and months 6 \>7.8 mmol/L
Change in glycemic variability Baseline and months 6 Change in percent of time below range Baseline and months 6 \<3.9 mmol/L
Change in resting metabolic rate Baseline and months 6 Resting metabolic rate will be assessed by indirect calorimetry.
Change in gut microbiome composition Baseline and months 6 Change in body weight Baseline and months 6 Change in waist circumference Baseline and months 6 Change in liver fat Baseline and months 6 Liver fat will be assessed by liver Fibroscan.
Change in Systolic Blood pressure Baseline and months 6 Change in HbA1c Baseline and months 6 Change in β cell function Baseline and months 6 Change in quality of life Baseline and months 6 Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)
Change in visceral fat Baseline and months 6 Visceral fat will be assessed by abdominal CT scan.
Change in Diastolic Blood pressure Baseline and months 6 Change in pulse wave velocity (PWV) Baseline and months 6 Change in insulin sensitivity Baseline and months 6
Trial Locations
- Locations (1)
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China