Obesity, PreDiabetes
Conditions
Keywords
TRE, The 5:2 diet, Glucose Homeostasis, prediabetes, obesity
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.
Interventions
BEHAVIORALTime-restricted eating
Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm).
BEHAVIORALThe 5:2 diet
Participants will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Men or women aged 18-75 years; 2. Prediabetes; 3. Body mass index (BMI)of 28.0 to 45.0 kg/m2;
Exclusion criteria
1. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 mean glucose levels | Baseline and months 6 | — |
| Change in visceral fat | Baseline and months 6 | Visceral fat will be assessed by abdominal CT scan. |
| Change in Systolic Blood pressure | Baseline and months 6 | — |
| Change in Diastolic 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) |
| Change in liver fat | Baseline and months 6 | Liver fat will be assessed by liver Fibroscan. |
Countries
China
Contacts
Primary ContactHuijie Zhang, MD.PhD
Outcome results
None listed