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A human study to evaluate safety and effective dose of Morus alba twig extract on postprandial glucose level in healthy subjects

Not Applicable
Completed
Conditions
Endocrine, nutritional and metabolic disease
Registration Number
KCT0001434
Lead Sponsor
Ewha Womans University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
24
Inclusion Criteria

1) Age: 20 years = Age < 40 years
2) FBG (Fasting Blood Glucose): < 126mg/dL

Exclusion Criteria

1) Continuous consumption of drug that affect glucose metabolism, inflammation, antioxidative capacity and lipid metabolism or dietary supplement or oriental medicine or within 4 weeks before the first visit
2) Consumption of anticoagulant within 4 weeks before the first visit
3) BMI=18.5 or BMI=30
4) Following diseases :
? Diagnosis of diabetes or fasting blood glucose = 126mg/dL at screening
? Liver dysfunction (AST, ALT level elevations more than 2.5 times the upper limit of normal)
? Renal dysfunction (serum creatinine = 1.4mg/dL)
? Cardiovascular diseases (hypertension (= 140/90 mmHg), stroke, etc.)
? Thyroid diseases, mental diseases such as depression, schizophrenia, alcoholism, drug addiction, wasting diseases such as malignant tumor etc., and severe muscular skeletal disease, asthma and allergic diseases, any condition that the principal investigator believes may put the subjects at undue risk
5) Chronic smoker (= 20 cigarettes / day)
6) Excessive exercise (= 10 hours / week)
7) Change of body weight more than 4 kg or weight control within 4 weeks before the first visit
8) Subjects with hypersensitivity to test materials
9) Participation in other human study within 4 weeks 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
NameTimeMethod
Blood glucose
Secondary Outcome Measures
NameTimeMethod
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