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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Intermittent fasting plus time-restricted eating; Behavioral: Calorie restriction

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huijie Zhang, MD. PhD.; Phone Number: +86-020-61641635; Email: huijiezhang2005@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital of Southern Medical University
      • Contact: Huijie Zhang, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The mTRE group; 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.	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.; Other Names: mTRE
Experimental: The CR group; Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on eating time.	Behavioral: 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.; Other Names: CR
No Intervention: Control; usual health care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight over 12 months	Change in body weight over 12 months	Baseline to months 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body fat composition meassured by DEXA	Body composition is meassured by dual-energy X-ray absorptiometry scans	Baseline to months 12
Change in β cell function	β cell function is assessed by HOMA-B	Baseline to months 12
Change in arterial stiffness measured by pulse wave velocity	arterial stiffness is measured by pulse wave velocity (PWV)	Baseline to months 12
Change in liver fat	Liver fat is assessed by liver Fibroscan	Baseline to months 12
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
Change in waist circumference	Wrap a tape measure around the waist at the level of the navel.	Baseline to months 12
Change in systolic blood pressure	blood pressure	Baseline to months 12
Change in diastolic blood pressure	blood pressure	Baseline to months 12
Change in concentration of serum triglyceride	the contents of serum triglyceride	Baseline to months 12
Change in concentration of serum total cholesterol	the contents of serum total cholesterol	Baseline to months 12
Change in concentration of serum LDL-c	the contents of Low Density Lipoprotein	Baseline to months 12
Change in concentration of HbA1c	the contents of Glycated hemoglobin	Baseline to months 12
Change in insulin sensitivity	Insulin sensitivity is assessed by HOMA-IR (Homeostatic Model Assessment for Insulin Resistance).	Baseline to months 12
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
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
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

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Huijie Zhang, MD. PhD., Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Weight loss; Calorie restriction; Intermittent Fasting; Time restricted eating; Modified Intermittent Eating strategy
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: NFEC-2024-033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No