Status Approved
First Submitted Date
2020/12/04
Registered Date
2021/02/03
Last Updated Date
2020/12/04
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005861 |
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Unique Protocol ID | PAIK 2020-09-010-002 |
Public/Brief Title | A Clinical Trial for the Evaluation of the Efficacy and Safety of MED-02 Probiotics on Reducing Body Fat |
Scientific Title | A 12 week, Multi-center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of MED-02 Probiotics on Reducing Body Fat |
Acronym | MEDIOGEN_MED-02 |
MFDS Regulated Study | Yes |
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 | PAIK 2020-09-010-002 |
Approval Date | 2020-11-09 |
Institutional Review Board Name | INJE UNIVERSITY SEOUL PAIK HOSPITAL IRB |
Institutional Review Board Address | 9, Mareunnae-ro, Jung-gu, Seoul |
Institutional Review Board Telephone | 02-2270-0945 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | YOUNGGYU CHO |
Title | Dr. |
Telephone | +82-2-2270-0097 |
Affiliation | Inje University Seoul Paik Hospital |
Address | 9, Mareunnae-ro, Jung-gu, Seoul 04552, Korea |
Contact Person for Public Queries | |
Name | YOUNGGYU CHO |
Title | Dr. |
Telephone | +82-2-2270-0097 |
Affiliation | Inje University Seoul Paik Hospital |
Address | 9, Mareunnae-ro, Jung-gu, Seoul 04552, Korea |
Contact Person for Updating Information | |
Name | YOUNGGYU CHO |
Title | Dr. |
Telephone | +82-2-2270-0097 |
Affiliation | Inje University Seoul Paik Hospital |
Address | 9, Mareunnae-ro, Jung-gu, Seoul 04552, Korea |
4. Status
Study Site | Multi-center Number of center : 2 | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-12-01 Actual | |
Target Number of Participant | 100 | |
Primary Completion Date | 2021-11-03 , Anticipated | |
Study Completion Date | 2021-11-03 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Inje University Seoul Paik Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-12-01 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Inje University Ilsan Paik Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-12-31 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Mediogen |
Organization Type | Others |
Project ID | MEDIOGEN_MED-02 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Inje University Seoul Paik Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Lactobacillus fermentum MG4231 and Lactobacillus fermentum MG4244 constituting MED-02 were confirmed to inhibit the differentiation of adipocytes and accumulation of triglycerides through cell experiments. , Lactobacillus fermentum MG4244 complex reduced body weight and body fat, reduced liver triglyceride and fat cell size, reduced factors related to fat differentiation and fat synthesis such as PPARγ, FAS, aP2, LPL, and improved expression of genes related to fat oxidation such as AMPK and ACC It was confirmed to be. This clinical trial was designed to evaluate the efficacy and safety of MED-02 probiotics in overweight or obese subjects on body fat reduction compared to placebo. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase2/Phase3 |
Intervention Model | Parallel |
Blinding/Masking | Double |
Blinded Subject | Subject, Investigator |
Allocation | RCT |
Intervention Type | Dietary Supplement |
Intervention Description | Intervention group: MED-02 probiotics 500mg capsule once a day Placebo group: placebo 500mg capsule once a day |
Number of Arms | 2 |
Arm 1 |
Arm Label Intervention group |
Target Number of Participant 50 |
|
Arm Type Experimental |
|
Arm Description Intervention group: MED-02 probiotics 500mg capsule once a day |
|
Arm 2 |
Arm Label Placebo group |
Target Number of Participant 50 |
|
Arm Type Placebo comparator |
|
Arm Description Placebo group: placebo 500mg capsule once a 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 Age: 19-65 Body mass index: 25~32 A person who agrees to participate in this human application test and writes a written consent |
|
Exclusion Criteria |
Those who are currently being treated for severe cardiovascular, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal system, psychotic, infectious disease and malignant tumor Those who use drugs that affect weight, health functional foods for weight control purposes, herbal medicines, or weight control formulas Those who administered antibiotics within 2 weeks Those who have consumed probiotics or lactobacillus products continuously within 2 weeks Patients with uncontrolled hypertension Diabetic patients with fasting blood sugar of 126 mg/dl or more or taking antidiabetic drugs Those whose TSH is less than 0.1 uIU/ml or more than 10 uIU/ml Those whose Creatinine is more than twice the normal upper limit Those whose AST/ALT is more than 3 times the normal upper limit Those who have problems in eating food for human application due to severe gastrointestinal disorders People with alcohol use disorder and/or CNS disorder Those who are judged to be unable to exercise due to musculoskeletal disorders Those who have had a weight change of 10% or more within 3 months Those who participated in a commercial obesity program within 3 months Those who have participated in other interventional clinical trials within one month or plan to participate in other interventional clinical trials Pregnant, nursing or planning to become pregnant A person who judges that the tester is inappropriate for other reasons |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Body fat mass |
|
Timepoint | week 0, week 12 |
|
Primary Outcome(s) 2 | ||
Outcome | body fat percentage |
|
Timepoint | week 0, week 12 |
|
Secondary Outcome(s) 1 | ||
Outcome | Body weight, Waist circumference, Hip circumference, WHR, BMI, Lean body mass, Visceral fat area, Subcutaneous fat area, total abdominal fat area, VSR |
|
Timepoint | week 0, week 12 |
|
Secondary Outcome(s) 2 | ||
Outcome | Total cholesterol/HDL cholesterol/LDL cholesterol/Triglyceride/hs-CRP/Adiponectin/Leptin |
|
Timepoint | week 0, week 12 |
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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