Human study for investigating the effectiveness and safety of black ginseng ethanol extract(GBG05-FF) in adults with impaired fasting glucose
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002242
- Lead Sponsor
- Inje University Seoul Paik Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
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/dL
4) HbA1c=5.7% and =6.4%
1) Continuous consumption of drug, oriental medicine, dietary supplement those that affect glucose metabolism 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
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) high intensity exercise regularly (> 10 hours / week)
6) Excessive smoker (= 20 cigarettes / day)
7) Alcoholics or those who Usually drinking more than 210 g of alcohol a week (soju about 3.5 bottles/week, 3.5 cup/day)
8) Subjects with hypersensitivity to test materials
9) Participation in other human study within 1 month before the first visit
10) Pregnant or lactating women
11) 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, C-peptide, HbA1c, Index of insulin resistance and sensitivity(Homeostasis model assessment-insulin resistance(Homa-ir), Quantitative insulin sensitivity check index(Quicki))
- Secondary Outcome Measures
Name Time Method Triglycerides(TG), Total cholesterol(TC), Low-density lipoprotein cholesterol(LDL-C), High-density lipoprotein cholesterol(HDL-C), Very low-density lipoprotein cholesterol(VLDL-C), Aspartate aminotransferase(AST), Alanine aminotransferase(ALT)