Efficacy and safety of FRGP on improving blood glucose and serum cholesterol; A 12week, multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial
Not Applicable
Recruiting
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002583
- Lead Sponsor
- BIFIDO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1) Adults aged 20 years old or more and less than 75 years old
2) Fasting glucose = 100 mg/dl and = 125 mg/dl
3) Subject who agrees to participate in the study and signs the informed consent form
Exclusion Criteria
1) Subjects who had insulin therapy, and/or oral hypoglucosuric agent previously within 3 months before the trial
2) Subjects who took corticosteroid drug previously within 2 months before the trial
3) Subject with uncontrolled hypertension (over 170/100mmHg, when measuring after 10 minutes steady)
4) Subject with TSH =0.1uU/ml or = 10 uU/ml
5) Subject with AST(GOT) or ALT(GPT) or ?-GTP = 3 times the upper limit of normal
6) Inappropriate subject decided by the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fasting blood glucose
- Secondary Outcome Measures
Name Time Method Total cholesterol, LDL-cholesterol, HDL-cholesterol ;Adverse Event ;Clinical pathology (hematology / blood chemical tests, urine tests)