Status Approved
First Submitted Date
2021/02/10
Registered Date
2021/02/23
Last Updated Date
2021/07/29
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005930 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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 | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | The Catholic University of Korea | |
Recruitment Status | Completed | |
Date of First Enrollment | 2020-08-12 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | National Research Foundation |
Organization Type | Government |
Project ID | NRF-2020R1F1A104944 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | The Catholic University of Korea |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (E00-E90)Endocrine, nutritional and metabolic diseases (E66.9)Obesity, unspecified Obesity, Risk Factors for Cardiovascular Disease |
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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)
Type of Primary Outcome | Not applicable | |
---|---|---|
Primary Outcome(s) 1 | ||
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
Result Registered |
Yes
Published |
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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 Statement | No |
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