Status Approved
First Submitted Date
2017/04/10
Registered Date
2017/04/19
Last Updated Date
2017/04/13
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0002313 |
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Unique Protocol ID | YWMR-15-9-081 |
Public/Brief Title | Effects of Intermittent Fasting on Mitochondrial Function and Oxidative Stress: A Crossover Study |
Scientific Title | Effects of Intermittent Fasting on Mitochondrial Function and Oxidative Stress: A Crossover Study |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | YWMR-15-9-081 |
Approval Date | 2015-11-11 |
Institutional Review Board Name | The Research Ethics Committee of Yonsei University Wonju College of Medicine |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Song Vogue Ahn |
Title | Associate Professor |
Telephone | +82-33-741-0348 |
Affiliation | Yonsei University |
Address | Department of Preventive Medicine, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwon-do 26426, South Korea |
Contact Person for Public Queries | |
Name | Song Vogue Ahn |
Title | Associate Professor |
Telephone | +82-33-741-0348 |
Affiliation | Yonsei University |
Address | Department of Preventive Medicine, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwon-do 26426, South Korea |
Contact Person for Updating Information | |
Name | Song Vogue Ahn |
Title | Associate Professor |
Telephone | +82-33-741-0348 |
Affiliation | Yonsei University |
Address | Department of Preventive Medicine, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwon-do 26426, South Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2015-11-13 Actual | |
Target Number of Participant | 36 | |
Primary Completion Date | 2016-05-13 , Actual | |
Study Completion Date | 2017-02-24 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Yonsei University | |
Recruitment Status | Completed | |
Date of First Enrollment | 2015-11-13 , |
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-2014R1A1A2059462 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Yonsei University |
Organization Type | University |
7. Study Summary
Lay Summary | This study aims to investigate the effects of intermittent fasting on health indicators in healthy adults. In this study, health indicators include mitochondrial function, oxidative stress, gut microbiome, and cardiovascular risk factors. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Basic Science |
Phase | Not applicable |
Intervention Model | Cross-over |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Behavioral |
Intervention Description | 1. Intervention period: Intermittent fasting for 8 weeks (fasting for 24 hours once a week) - Subjects do not eat any food except water during fasting. - During non-fasting, subjects are allowed to freely eat meals and snacks as usual, but do not intentionally reduce or increase the frequency or amount of meals. 2. Control period: Non-fasting diet for 8 weeks - Subjects are allowed to freely eat meals and snacks as usual, but do not intentionally reduce or increase the frequency or amount of meals. 3. 8-week washout period is included between the intervention period and the control period. |
Number of Arms | 2 |
Arm 1 |
Arm Label Intervention-Control group |
Target Number of Participant 18 |
|
Arm Type Others |
|
Arm Description 1. First, an intervention period of 8 weeks (fasting for 24 hours once a week) 2. Second, a washout period of 8 weeks 3. Third, a control period of 8 weeks (Non-fasting diet for 8 weeks) |
|
Arm 2 |
Arm Label Control-Intervention group |
Target Number of Participant 18 |
|
Arm Type Others |
|
Arm Description 1. First, a control period of 8 weeks (Non-fasting diet for 8 weeks) 2. Second, a washout period of 8 weeks 3. Third, an intervention period of 8 weeks (fasting for 24 hours once a week) |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (E00-E90)Endocrine, nutritional and metabolic diseases (E66.9)Obesity, unspecified |
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Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 25Year~45Year |
|
Description 1. Healthy women 2. Volunteers 3. Body mass index ≥ 23 4. Usual eating pattern of 2 or 3 meals/day during the past 1 year |
|
Exclusion Criteria |
1. Smokers 2. History of diabetes 3. History of CVD 4. Regular use of medications 5. History of major psychiatric disorders 6. History of eating disorders 7. Individuals who have attempted intentional weight control or dietary restriction during the past 1 year 8. Individuals with alcoholism or other substance abuse 9. Pregnancy or lactation 10. High-risk occupations requiring full alertness and motor skills (airplane pilots, etc) |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Changes in mitochondrial DNA copy number |
|
Timepoint | Baseline, Week 8 |
|
Secondary Outcome(s) 1 | ||
Outcome | Changes in oxidized LDL |
|
Timepoint | Baseline, Week 8 |
|
Secondary Outcome(s) 2 | ||
Outcome | Changes in gut microbiome |
|
Timepoint | Baseline, Week 8 |
|
Secondary Outcome(s) 3 | ||
Outcome | Changes in FGF-21 |
|
Timepoint | Baseline, Week 8 |
|
Secondary Outcome(s) 4 | ||
Outcome | Changes in cytokines |
|
Timepoint | Baseline, Week 8 |
|
Secondary Outcome(s) 5 | ||
Outcome | Changes in adipokines |
|
Timepoint | Baseline, Week 8 |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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