Intermittent Eating on Glucose Homeostasis in Prediabetes

Obesity Clinical Trial

Official title:

Effects of Intermittent Eating on Glucose Homeostasis in Prediabetes: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05717387
• Other study ID #: NFEC-2023-017
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Obesity
• PreDiabetes
• Prediabetic State

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