Clinical Trial to Test Anti-Obesity effect of JINIS JBD301 on Humans
- Conditions
- Not Applicable
- Registration Number
- KCT0000452
- Lead Sponsor
- JINIS Biopharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
1) Written informed consent
2) Men and women between 20-65 years of age
3) Body mass index between 25 ~ 35kg/m2
1) Subjects who have received antibiotics within 12 week prior to the first visit
2) Subject with current use of medications for body weight reduction (lipase inhibitor, anti-depressants, appetite suppressant), diuretics, contraceptives, steroids, and hormones
3) Subjects who have been involved in commercial diet programs or under diet formula within 12 weeks prior to the first visit
4) Subjects with uncontrolled hypertension or diabetes
5) Subjects with current medical conditions, including cardiac, renal, hepatic, neurovascular, thyroid and parathyroid disorders/diseases
6) Subjects with medical conditions, including depression, schizophrenia, psychosis, alcohol abuse and drug abuse
7) Subjects diagnosed with cancer within 5 years
8) Subjects with hyper-allergic conditions to components in the testing food
9) Subjects who is planning to reduce body weight by food and exercise during the clinical trial period
10) Subject with current pregnancy or breast feeding
11) Subject is otherwise unsuitable for the study, in the opinion of the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total abdomenal fat (CT) value;Body Weight, BMI;Total abdomenal fat (CT) variation;Blood lipid profile: TG, TC, LDL-C, HDL-C, free fatty acid ;Glucose: fasting blood glucose, blood insulin, HbA1c
- Secondary Outcome Measures
Name Time Method Abnormal reaction, Vital signs(blood pressure, Pulse), Laboratory tests(complete blood and urine tests)