Status Approved
First Submitted Date
2013/05/09
Registered Date
2013/05/29
Last Updated Date
2014/07/01
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0000756 |
|---|---|
| Unique Protocol ID | BNR17(Ob)_Bioneer |
| Public/Brief Title | Effect of Lactobacillus gasseri BNR17 on body fat reduction |
| Scientific Title | Effect of Lactobacillus gasseri BNR17 consumption on body fat reduction in obese adults |
| 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 |
|---|---|
| Board Approval Number | H-1205-082-410 |
| Approval Date | 2012-07-11 |
| Institutional Review Board Name | Seoul National University Hospital IRB |
| Institutional Review Board Address | |
| Institutional Review Board Telephone | |
| Data Monitoring Committee | No |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Belong Cho |
| Title | MD, Ph.D |
| Telephone | +82-2-2072-2195 |
| Affiliation | Seoul National University Hospital |
| Address | |
| Contact Person for Public Queries | |
| Name | Jae Moon Yun |
| Title | MD |
| Telephone | +82-2-2072-3353 |
| Affiliation | Seoul National University Hospital |
| Address | |
| Contact Person for Updating Information | |
| Name | Joohee Kim |
| Title | Ph.D |
| Telephone | +82-2-364-0839 |
| Affiliation | Ewha Womens University |
| Address | |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Completed | |
| Date of First Enrollment | 2013-05-08 Actual | |
| Target Number of Participant | 90 | |
| Primary Completion Date | 2013-11-19 , Actual | |
| Study Completion Date | 2013-11-29 , Actual | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Seoul National University Hospital | |
| Recruitment Status | Completed | |
| Date of First Enrollment | 2013-05-08 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Bioneer |
| Organization Type | Others |
| Project ID | |
| 2. Source of Monetary/Material Support | |
| Organization Name | Ministry of Agriculture, Food and Rural Affairs |
| Organization Type | Government |
| Project ID | |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Bioneer |
| Organization Type | Others |
7. Study Summary
| Lay Summary | This study is randomized controlled, double-blind, parallel study for evaluating the effect of Lactobacillus gasseri BNR17 on body fat reduction. After 12-week consumption of Lactobacillus gasseri BNR17 or placebo, CT, DEXA, blood lipid profile, blood inflammatory biomarkers will be evaluated. |
|---|
8. Study Design
| Study Type | Interventional Study |
|---|---|
| Study Purpose | Others |
| Phase | Not applicable |
| Intervention Model | Parallel |
| Blinding/Masking | Double |
| Blinded Subject | Subject, Investigator |
| Allocation | RCT |
| Intervention Type | Dietary Supplement |
| Intervention Description | Consumption of Lactobacillus gasseri BNR17 for 12 weeks (10^9 CFU/day or 10^10 CFU/day) |
| Number of Arms | 3 |
| Arm 1 |
Arm Label Control group (placebo) |
|
Target Number of Participant 30 |
|
|
Arm Type Placebo comparator |
|
|
Arm Description Consumption of placebo for 12 weeks |
|
| Arm 2 |
Arm Label Experimental group (low dose) |
|
Target Number of Participant 30 |
|
|
Arm Type Experimental |
|
|
Arm Description Consumption of Lactobacillus gasseri BNR17 for 12 weeks (10^9 CFU/day). |
|
| Arm 3 |
Arm Label Experimental group (high dose) |
|
Target Number of Participant 30 |
|
|
Arm Type Experimental |
|
|
Arm Description Consumption of Lactobacillus gasseri BNR17 for 12 weeks (10^10 CFU/day). |
9. Subject Eligibility
| Condition(s)/Problem(s) |
* (E00-E90)Endocrine, nutritional and metabolic diseases (E66.9)Obesity, unspecified |
|---|---|
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 20Year~65Year |
|
|
Description 1) Voluntarily agree to participate and sign in informed consent form 2) Age: 20-65 years 3) BMI: 25kg/m2 ≤ ~ ≤ 35kg/m2 |
|
| Exclusion Criteria |
1) Subject who takes antiobesity drugs that affect body weight. 2) Subject who consumes probiotics within 2 weeks before the first visit. 3) Subject who cannot follow the dietary instruction during the study. 4) Subject who has following diseases:hypertension (≥160/100mmHg), diabetes, hepatic dysfunction, renal dysfunction, hyperthyroidism or hypothyroidism, Cushing's syndrome, malignant tumors. 6) Subject who has an allergy to the ingredients of study product. 7) Subject who participated in another clinical trials within 4 weeks before the first visit. 8) Subject who is pregnant or bresat feeding. 9) Any condition that would make the subject unsuitable for enrollment in this study. |
| Healthy Volunteers | Yes |
10. Outcome Measure(s)
| Type of Primary Outcome | Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | CT (Abdominal fat area: total fat area, visceral fat areat, subcutaneous fat area) |
|
| Timepoint | 0, 12 weeks |
|
| Secondary Outcome(s) 1 | ||
| Outcome | DEXA (body fat mass, lean body mass, %body fat) |
|
| Timepoint | 0, 12 weeks |
|
| Secondary Outcome(s) 2 | ||
| Outcome | Anthropometric measurements (body weight, BMI, waist circumference, hip circumference) |
|
| Timepoint | 0, 6,12 weeks |
|
| Secondary Outcome(s) 3 | ||
| Outcome | Blood lipid profiles |
|
| Timepoint | 0, 6, 12 weeks |
|
| Secondary Outcome(s) 4 | ||
| Outcome | Biomarkers of blood glucose |
|
| Timepoint | 0, 6, 12 weeks |
|
| Secondary Outcome(s) 5 | ||
| Outcome | Blood inflammatory biomarkers |
|
| Timepoint | 0, 12 weeks |
|
11. Study Results and Publication
| Result Registered |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | Not provided at time of Registration |
|---|
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