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The effect of meal-timing based dietary intervention on body weight and cardiometabolic risk factors

Status Approved

First Submitted Date

2021/02/10
Registered Date

2021/02/23
Last Updated Date

2021/07/29

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005930
Unique Protocol ID	1040395-202007-01
Public/Brief Title	The effect of intermittent fasting on body weight and metabolic risk factors
Scientific Title	The effect of meal-timing based dietary intervention on body weight and cardiometabolic risk factors
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	1040395-202007-01
Approval Date	2020-07-24
Institutional Review Board Name	CUK IRB (The Catholic University of Korea Institutional Review Board)
Institutional Review Board Address	H208-1 Jibong-ro 43 Bucheon-si Gyeonggi-do 14662
Institutional Review Board Telephone	02-2164-4827
Data Monitoring Committee	Yes CUK IRB (The Catholic University of Korea Institutional Review Board)

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	YoonJu Song
Title	Prof.
Telephone	+82-2-2164-4681
Affiliation	The Catholic University of Korea
Address	43 Jibong-ro Wonmi-gu Bucheon-si Gyeonggi-do Korea
Contact Person for Public Queries
Name	YoonJu Song
Title	Prof.
Telephone	+82-2-2164-4681
Affiliation	The Catholic University of Korea
Address	43 Jibong-ro Wonmi-gu Bucheon-si Gyeonggi-do Korea
Contact Person for Updating Information
Name	YoonJu Song
Title	Prof.
Telephone	+82-2-2164-4681
Affiliation	The Catholic University of Korea
Address	43 Jibong-ro Wonmi-gu Bucheon-si Gyeonggi-do Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2020-08-12 Actual
Target Number of Participant	35
Primary Completion Date	2020-09-17 , Actual
Study Completion Date	2020-09-17 , Actual
Name of Study	The Catholic University of Korea
Recruitment Status	Completed
Date of First Enrollment	2020-08-12 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Research Foundation
Organization Type	Government
Project ID	NRF-2020R1F1A104944

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	The Catholic University of Korea
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	This study aims to examine the effect of meal-timing based dietary intervention for 4 weeks on body weight and cardiovascular disease risk factors in healthy adults aged 18 years and over in their 20s and 30s in Korea. Meal-timing defined in this study is a time-restricted feeding type, dividing the day into 16-hour fasting and 8-hour intake intervals, and the subject sets an 8-hour intake interval and continues for 4 weeks. The hypothesis to be tested through this dietary intervention is that the 4-week time-limited diet intervention significantly improves body weight and serum indices in healthy young adults with no specific metabolic disease risk.

Study Summary Information

Lay Summary

This study aims to examine the effect of meal-timing based dietary intervention for 4 weeks on body weight and cardiovascular disease risk factors in healthy adults aged 18 years and over in their 20s and 30s in Korea. Meal-timing defined in this study is a time-restricted feeding type, dividing the day into 16-hour fasting and 8-hour intake intervals, and the subject sets an 8-hour intake interval and continues for 4 weeks. The hypothesis to be tested through this dietary intervention is that the 4-week time-limited diet intervention significantly improves body weight and serum indices in healthy young adults with no specific metabolic disease risk.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	Others
Intervention Description	Intervention is 8-hour time-restricted feeding type, which is divided the day into 16-hour fasting and 8-hour feeding intervals, and the subject sets their own eating time-window and stick to the eating window for 4 weeks.
Number of Arms	1
Arm 1	Arm Label Time-restricted feeding
	Target Number of Participant 35
	Arm Type Experimental
	Arm Description A time-restricted feeding type is divided the day into 16-hour fasting and 8-hour intake intervals, and the subject sets an 8-hour intake interval and continues for 4 weeks.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (E00-E90)Endocrine, nutritional and metabolic diseases (E66.9)Obesity, unspecified Obesity, Risk Factors for Cardiovascular Disease
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~30Year
	Description Adults aged 18-30 years old who can faithfully perform 4-week meal interventions without specific metabolic disease
Exclusion Criteria	1) Subjects who have a history of metabolic disease and who are currently taking drugs (metabolic diseases include diabetes, dyslipidemia, metabolic syndrome), 2) those who gained or lost weight in the last month (more than 10% of their existing weight), 3) Those who cannot secure normal sleep time due to part-time work or outside routine
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	body weight
Timepoint	baseline, 4 weeks
Primary Outcome(s) 2
Outcome	blood lipids
Timepoint	baseline, 4 weeks
Primary Outcome(s) 3
Outcome	fasting blood glucose
Timepoint	baseline, 4 weeks
Primary Outcome(s) 4
Outcome	serum insulin
Timepoint	baseline, 4 weeks
Secondary Outcome(s) 1
Outcome	Sleep quality variables
Timepoint	baseline
Secondary Outcome(s) 2
Outcome	psychometric variables
Timepoint	baseline
Secondary Outcome(s) 3
Outcome	dietary intake
Timepoint	28 days

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	Yes Published
Final Enrollment Number	33
Number of Publication	1
Publications 1	Su-Jeong Park, Jae-Won Yang and Yoon-Ju Song. The effect of four weeks dietary intervention with 8-hour time-restricted eating on body composition and cardiometabolic risk factors in young adults. Nutrients. SCI. 2021-06-24 , VOL : 13 page : 2164 ~ 2164 https://doi.org/10.3390/nu13072164
Results Upload
Date of Posting Results	2021/07/05
Protocol URL or File Upload
Brief Summary	A total of 33 young adults completed the 8h TRE for 4 weeks. Participants experienced significant changes in body weight (−1.0 ± 1.4 kg), body mass index (−0.4 ± 0.5 kg/m2), and body fat (−0.4 ± 1.9%) after 4 weeks of TRE. When participants were divided into weight loss/gain groups based on their weight change in week 4, fat mass reduction was significantly higher in the weight loss group than in the weight gain group. Regarding cardiometabolic risk factors, levels of fasting insulin and insulin resistance improved in the weight loss group after intervention, but not in the weight gain group. All subjects showed late-shifted sleeping patterns, but no significant differences in sleep duration, sleep quality, or psychological measures between the two groups. When meal frequency and energy proportion were evaluated, the average meal frequency was 2.8 ± 0.5 and energy proportions of breakfast, lunch, dinner, and snacks were 4.5, 39.2, 37.6, and 18.5%, respectively; there were no significant differences between the two groups. However, the saturated fat intake at dinner was lower in the weight loss group (3.1 ± 3.2%, 6.0 ± 2.5% respectively). In conclusion, an 8h TRE can be used as a lifestyle strategy in the management of body weight and cardiometabolic risk factors among healthy young adults.

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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