Intermittent Eating on Glucose Homeostasis in Prediabetes

NCT ID: NCT05717387

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-11
• Study Completion Date: 2024-12-31

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.

Conditions

PreDiabetes; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Time-restricted eating

Intervention Type: BEHAVIORAL

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 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.

Group Type: EXPERIMENTAL

The 5:2 diet

Intervention Type: BEHAVIORAL

Participants will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days.

Control

Participants in the control group will receive a general lifestyle counseling.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Huijie Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huijie Zhang, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

Locations

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huijie Zhang, MD.PhD

Role: CONTACT

Huijiezhang2005@126.com

+86-020-61641635

Facility Contacts

Huijie Zhang, MD,PhD

Role: primary

Other Identifiers

NFEC-2023-017

Identifier Type: -

Identifier Source: org_study_id