Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial)

Obesity Clinical Trial

— INTEREST-3  

Official title:

Effects of Modified Intermittent Eating Strategy on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06302803
• Other study ID #: NFEC-2024-033
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: March 2024
• 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

Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained 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 days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.

Description:

Obesity is becoming a major global public health issue. Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained 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 days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: July 1, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Man or women aged 18-75 years;

2. 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 or weight change in the past 3 months (> 5% current body weight) ;

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

• Obesity
• Weight Loss

Intervention

Behavioral:
• Intermittent fasting plus time-restricted eating
Participants in the mTRE group will be instructed to eat during a window of 8 h (8 am to 4 pm) 5 days and fast (approximately 500-600 kcal per day) 2 days per week.
• Calorie restriction
Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on eating time.

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 body weight over 12 months	Change in body weight over 12 months	Baseline to months 12
Secondary	Change in body mass index (BMI)	body mass index : the weight in kilograms divided by the square of the height in meters.The higher scores mean a worse outcome.	Baseline to months 12
Secondary	Change in waist circumference	Wrap a tape measure around the waist at the level of the navel.	Baseline to months 12
Secondary	Change in body fat composition meassured by DEXA	Body composition is meassured by dual-energy X-ray absorptiometry scans	Baseline to months 12
Secondary	Change in liver fat	Liver fat is assessed by liver Fibroscan	Baseline to months 12
Secondary	Change in systolic blood pressure	blood pressure	Baseline to months 12
Secondary	Change in diastolic blood pressure	blood pressure	Baseline to months 12
Secondary	Change in concentration of serum triglyceride	the contents of serum triglyceride	Baseline to months 12
Secondary	Change in concentration of serum total cholesterol	the contents of serum total cholesterol	Baseline to months 12
Secondary	Change in concentration of serum LDL-c	the contents of Low Density Lipoprotein	Baseline to months 12
Secondary	Change in concentration of HbA1c	the contents of Glycated hemoglobin	Baseline to months 12
Secondary	Change in insulin sensitivity	Insulin sensitivity is assessed by HOMA-IR (Homeostatic Model Assessment for Insulin Resistance).	Baseline to months 12
Secondary	Change in ß cell function	ß cell function is assessed by HOMA-B	Baseline to months 12
Secondary	Change in arterial stiffness measured by pulse wave velocity	arterial stiffness is measured by pulse wave velocity (PWV)	Baseline to months 12
Secondary	Change in depression score measured by the Patient Health Questionnaire-9	Depression is measured by the Patient Health Questionnaire-9 (PHQ-9). The maximum value is 27, and the minimum value is 0 . The higher scores mean a worse outcome.	Baseline to months 12
Secondary	Change in quality of sleep score measured by the Pittsburgh sleep quality index	Quality of sleep is measured by the Pittsburgh sleep quality index (PSQI). The maximum value is 21, and the minimum value is 0 . The higher scores mean a worse outcome.	Baseline to months 12
Secondary	Change in quality of life score measured by the 12-item Short-Form Health Survey Questionnaire	Quality of life is measured by the 12-item Short-Form Health Survey Questionnaire (SF-12). The maximum value is 100, and the minimum value is 0 . The higher scores mean a better outcome.	Baseline to months 12