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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05717387
Other study ID # NFEC-2023-017
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 11, 2023
Est. completion date December 2024

Study information

Verified date November 2023
Source Nanfang Hospital, Southern Medical University
Contact Huijie Zhang, MD.PhD
Phone +86-020-61641635
Email Huijiezhang2005@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 87
Est. completion date December 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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).
The 5:2 diet
Participants will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days.

Locations

Country Name City State
China Nanfang Hospital of Southern Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in mean glucose levels Baseline and months 6
Secondary Change in glycemic variability Baseline and months 6
Secondary Change in percent of time below range <3.9 mmol/L Baseline and months 6
Secondary Change in percent of time above range >7.8 mmol/L Baseline and months 6
Secondary Change in resting metabolic rate Resting metabolic rate will be assessed by indirect calorimetry. Baseline and months 6
Secondary Change in gut microbiome composition Baseline and months 6
Secondary Change in bile acid level Baseline and months 6
Secondary Change in body weight Baseline and months 6
Secondary Change in body composition Body composition will be assessed by DEXA. Baseline and months 6
Secondary Change in waist circumference Baseline and months 6
Secondary Change in body mass index Baseline and months 6
Secondary Change in liver fat Liver fat will be assessed by liver Fibroscan. Baseline and months 6
Secondary Change in visceral fat Visceral fat will be assessed by abdominal CT scan. Baseline and months 6
Secondary Change in Systolic Blood pressure Baseline and months 6
Secondary Change in Diastolic Blood pressure Baseline and months 6
Secondary Change in blood lipids Baseline and months 6
Secondary Change in HbA1c Baseline and months 6
Secondary Change in insulin sensitivity Baseline and months 6
Secondary Change in ß cell function Baseline and months 6
Secondary Change in pulse wave velocity (PWV) Baseline and months 6
Secondary Change in quality of life Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12) Baseline and months 6
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