Human study for investigating the effectiveness and safety of Mulberry ethanol extract in adults whose fasting glucose is borderline.
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002525
- Lead Sponsor
- Bundang Jesaeng Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 70
1) Subject who voluntarily agrees to participate and sign in informed consent form
2) Adults (Age=20 years)
3) Fasting blood glucose=100 mg/dL and =125 mg/d
1) Continuous consumption of drug, oriental medicine, dietary supplement those that affect glucose metabolism, antioxidant within 1 month before the first visit
2) Following diseases :
- cardiac failure, coronary artery disease, uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg), hyperlipidemia, diabetes (fasting blood glucose =126 mg / dL), renal dysfunction (rising more than 1.5 times the upper limit of normal creatinine) Hepatic dysfunction (ALT, AST three times higher than normal upper limit), hypothyroidism, chronic gastrointestinal disorders, gastrointestinal surgery, acute and chronic inflammatory diseases, malignant tumors, Mental diseases, chronic or serious patients who need to take medication in the long term
3) BMI=18.5 kg/m2 or BMI=30 kg/m2
4) Subjects who controlling body weight or subjects who have changed of body weight more than 10 percent within 6 months before the first visit
5) Excessive smoker (= 20 cigarettes / day)
6) Alcoholics
7) Subjects with hypersensitivity to test materials
8) Participation in other human study within 1 month before the first visit
9) Pregnant or lactating women
10) Any condition that the principal investigator believes may put the subjects at undue risk
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glucose, Insulin
- Secondary Outcome Measures
Name Time Method Index of insulin resistance and sensitivity (HOMA-IR)