Status Approved
First Submitted Date
2021/03/16
Registered Date
2021/03/19
Last Updated Date
2021/03/16
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0006015 |
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Unique Protocol ID | GO2KA1-BF-IL |
Public/Brief Title | A 12-week, randomized, double-blind, placebo-controlled human trial of Chitooligosaccharide(GO2KA1) on decrease of body fat |
Scientific Title | A 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Chitooligosaccharide(GO2KA1) on decrease of body fat |
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 | WKUIOMH-IRB-2019-09 |
Approval Date | 2019-09-20 |
Institutional Review Board Name | Wonkwang University Iksan Korean Medicine Hospital Institutional Review Board |
Institutional Review Board Address | 895, Muwang-ro, Iksan-si, Jeollabuk-do |
Institutional Review Board Telephone | 063-859-2849 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Jeonghan Lee |
Title | professor |
Telephone | +82-63-859-2807 |
Affiliation | Wonkwang University. Iksan Korean Medicine Hospital |
Address | 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of Korea |
Contact Person for Public Queries | |
Name | Jeonghan Lee |
Title | professor |
Telephone | +82-63-859-2807 |
Affiliation | Wonkwang University. Iksan Korean Medicine Hospital |
Address | 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of Korea |
Contact Person for Updating Information | |
Name | Jeonghan Lee |
Title | professor |
Telephone | +82-63-859-2807 |
Affiliation | Wonkwang University. Iksan Korean Medicine Hospital |
Address | 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2019-09-30 Actual | |
Target Number of Participant | 80 | |
Primary Completion Date | 2020-02-12 , Actual | |
Study Completion Date | 2020-02-28 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Wonkwang University. Iksan Korean Medicine Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2019-09-30 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Biostream Technology |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Wonkwang University. Iksan Korean Medicine Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | This study is a 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Chitooligosaccharide(GO2KA1) on decrease of body fat. For decrease of body fat, prescribed Chitooligosaccharide(GO2KA1) for 12 weeks. The measures of this study are to evaluate the efficacy and safety of Chitooligosaccharide(GO2KA1) on improvement of decrease of body fat. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Prevention |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Double |
Blinded Subject | Subject, Investigator |
Allocation | RCT |
Intervention Type | Dietary Supplement |
Intervention Description | • Chitooligosaccharide(GO2KA1) group: twice a day, 2 capsules once, after breakfast and dinner, for 12 weeks{1,600 mg/day, 1,200 mg/day for Chitooligosaccharide(GO2KA1)} • Placebo group: twice a day, 2 capsules once, after breakfast and dinner, for 12 weeks(1,600 mg/day) |
Number of Arms | 2 |
Arm 1 |
Arm Label Chitooligosaccharide(GO2KA1) group |
Target Number of Participant 40 |
|
Arm Type Experimental |
|
Arm Description • Chitooligosaccharide(GO2KA1) group: twice a day, 2 capsules once, after breakfast and dinner, for 12 weeks{1,600 mg/day, 1,200 mg/day for Chitooligosaccharide(GO2KA1)} |
|
Arm 2 |
Arm Label Placebo group |
Target Number of Participant 40 |
|
Arm Type Placebo comparator |
|
Arm Description • Placebo group: twice a day, 2 capsules once, after breakfast and dinner, for 12 weeks(1,600 mg/day) |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (E00-E90)Endocrine, nutritional and metabolic diseases (E66.9)Obesity, unspecified overweight or obesity |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~65Year |
|
Description 1) 25 ≤ BMI ≤ 34.9 kg/m2 or 25%(male), 30%(female) ≤body fat percentage 2) Participants who have fully understood information provided about the study, voluntarily decided to participate, and agreed to comply with precautions |
|
Exclusion Criteria |
1) Participants who have had a weight change of 10% of more within the 3 months prior to the screening examination. 2) Participants with a clinically significant disease requiring treatment (i.e., acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, kidney and urinary system, neuropsychiatric system, musculoskeletal inflammation, inflammatory disease, blood and tumor disease, gastrointestinal disease, etc.) 3) Fasteners 4) Participants with a history of antipsychotic medication use within 3 months prior to the screening examination. 5) Participants who have participated in other interventional clinical trials within 3 months prior to the screening examination, or plan to participate in other interventional clinical trials. 6) Participants who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes. |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Fat mass by DEXA(Dual-energy X-ray absorptiometry) |
|
Timepoint | 0, 12 weeks |
|
Primary Outcome(s) 2 | ||
Outcome | Percent Body Fat by DEXA(Dual-energy X-ray absorptiometry) |
|
Timepoint | 0, 12 weeks |
|
Secondary Outcome(s) 1 | ||
Outcome | weight |
|
Timepoint | screening, 0, 6, 12 weeks |
|
Secondary Outcome(s) 2 | ||
Outcome | Body Mass Index(BMI) |
|
Timepoint | screening, 0, 6, 12 weeks |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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