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Intermittent Eating on Sustaining Weight-loss in Obesity (INTEREST)

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Time-restricted eating
The 5:2 diet
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Time restricted eating, The 5:2 diet, Weight loss maintenance

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

The TRE group

The 5:2 diet group

Control

Arm Description

Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm).

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 will receive a general lifestyle counseling.

Outcomes

Primary Outcome Measures

Change in body weight over 12 months

Secondary Outcome Measures

Change in body fat composition meassured by DEXA
Body composition is meassured by dual-energy X-ray absorptiometry scans
Change in waist circumference
Change in body mass index
Change in liver fat
Liver fat is assessed by liver Fibroscan.
Change in systolic blood pressure
Change in diastolic blood pressure
Change in serum triglycerides
Change in serum total cholesterol
Change in serum LDL-c
Change in HbA1c
Change in insulin sensitivity
Insulin sensitivity is assessed by HOMA-IR
Change in β cell function
β cell function is assessed by HOMA-B
Change in arterial stiffness measured by pulse wave velocity
arterial stiffness is measured by pulse wave velocity (PWV)
Change in depression score measured by the Patient Health Questionnaire-9
Depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
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)
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)

Full Information

First Posted
June 18, 2022
Last Updated
October 21, 2022
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05453617
Brief Title
Intermittent Eating on Sustaining Weight-loss in Obesity
Acronym
INTEREST
Official Title
Effects of Intermitting Eating on Weight-Loss Maintenance and Cardiometabolic Risk Factors in Obese Adults: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
July 15, 2025 (Anticipated)
Study Completion Date
July 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Weight regain after weight loss is a major problem in the treatment of obesity. 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 weight loss maintenance and cardiometabolic risk factors after a low-calorie diet in obese adults over 12 months compared to usual health care.
Detailed Description
Weight regain after weight loss is a major problem in the treatment of persons with obesity. 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 weight loss and cardioprotection in humans. Whether TRE or the 5:2 diet is an effective approach for weight-loss maintenance remains unknown. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on weight loss maintenance and cardiometabolic risk factors after a low-calorie diet in obese adults over 12 months compared to usual health care. All participants who have achieved greater than 5% of weight loss after a 8-week low-calorie-diet induced weight loss phase, will be assigned to one of the three study groups (TRE, the 5:2 diet and control groups) in a 1:1:1 ratio. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Time restricted eating, The 5:2 diet, Weight loss maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The TRE group
Arm Type
Experimental
Arm Description
Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm).
Arm Title
The 5:2 diet group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in the control group will receive a general lifestyle counseling.
Intervention Type
Behavioral
Intervention Name(s)
Time-restricted eating
Intervention Description
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
Intervention Name(s)
The 5:2 diet
Intervention Description
Participants will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days.
Primary Outcome Measure Information:
Title
Change in body weight over 12 months
Time Frame
Baseline to months 12
Secondary Outcome Measure Information:
Title
Change in body fat composition meassured by DEXA
Description
Body composition is meassured by dual-energy X-ray absorptiometry scans
Time Frame
Baseline to months 12
Title
Change in waist circumference
Time Frame
Baseline to months 12
Title
Change in body mass index
Time Frame
Baseline to months 12
Title
Change in liver fat
Description
Liver fat is assessed by liver Fibroscan.
Time Frame
Baseline to months 12
Title
Change in systolic blood pressure
Time Frame
Baseline to months 12
Title
Change in diastolic blood pressure
Time Frame
Baseline to months 12
Title
Change in serum triglycerides
Time Frame
Baseline to months 12
Title
Change in serum total cholesterol
Time Frame
Baseline to months 12
Title
Change in serum LDL-c
Time Frame
Baseline to months 12
Title
Change in HbA1c
Time Frame
Baseline to months 12
Title
Change in insulin sensitivity
Description
Insulin sensitivity is assessed by HOMA-IR
Time Frame
Baseline to months 12
Title
Change in β cell function
Description
β cell function is assessed by HOMA-B
Time Frame
Baseline to months 12
Title
Change in arterial stiffness measured by pulse wave velocity
Description
arterial stiffness is measured by pulse wave velocity (PWV)
Time Frame
Baseline to months 12
Title
Change in depression score measured by the Patient Health Questionnaire-9
Description
Depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Time Frame
Baseline to months 12
Title
Change in quality of sleep score measured by the Pittsburgh sleep quality index
Description
Quality of sleep is measured by the Pittsburgh sleep quality index (PSQI)
Time Frame
Baseline to months 12
Title
Change in quality of life score measured by the 12-item Short-Form Health Survey Questionnaire
Description
Quality of life is measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)
Time Frame
Baseline to months 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huijie Zhang, MD. PhD.
Phone
+86-020-61641635
Email
Huijiezhang2005@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huijie Zhang, MD. PhD.
Organizational Affiliation
Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huijie Zhang, MD. PhD.
Phone
+86-020-61641635
Email
Huijiezhang2005@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Intermittent Eating on Sustaining Weight-loss in Obesity

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