Intermittent Eating on Glucose Homeostasis in Prediabetes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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) |
Behavioral: 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).
|
| Experimental: the 5:2 diet 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. |
Behavioral: The 5:2 diet
Participants will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days.
|
| No Intervention: Control Participants in the control group will receive a general lifestyle counseling. |
Outcome Measures
Primary Outcome Measures
- 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
- Change in mean glucose levels [Baseline and months 6]
- 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 percent of time above range [Baseline and months 6]
>7.8 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 bile acid level [Baseline and months 6]
- Change in body weight [Baseline and months 6]
- Change in body composition [Baseline and months 6]
Body composition will be assessed by DEXA.
- Change in waist circumference [Baseline and months 6]
- Change in body mass index [Baseline and months 6]
- Change in liver fat [Baseline and months 6]
Liver fat will be assessed by liver Fibroscan.
- Change in visceral fat [Baseline and months 6]
Visceral fat will be assessed by abdominal CT scan.
- Change in Blood pressure [Baseline and months 6]
- Change in blood lipids [Baseline and months 6]
- Change in HbA1c [Baseline and months 6]
- Change in insulin sensitivity [Baseline and months 6]
- Change in β cell function [Baseline and months 6]
- Change in pulse wave velocity (PWV) [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- Men or women aged 18-75 years; 2. Prediabetes; 3. Body mass index (BMI)of 28.0 to 45.0 kg/m2;
Exclusion Criteria:
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- History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis; 2. Diagnosis of type 1 and type 2 diabetes; 3. History of malignant tumors; 4. 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); 5. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months; 6. History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months; 7. History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity; 8. Being a smoker or having been a smoker in the 3 months prior to their screening visit; 9. 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; 10. Currently participating in weight loss programs; 11. Women who are pregnant or plan to become pregnant; 12. Patients who cannot be followed for 24 months (due to a health situation or migration); 13. Patients who are unwilling or unable to give informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | China | 510515 |
Sponsors and Collaborators
- Nanfang Hospital of Southern Medical University
Investigators
- Principal Investigator: Huijie Zhang, MD.PhD, Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NFEC-2023-017