A human study for evaluation of the effect of pinitol on improving hepatic function .
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0001672
- Lead Sponsor
- Ewha Womans University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
1) Subject who voluntarily agrees to participate and signs in informed consent form
2) Age: = 20 years
3) Subject who has fatty liver
4) one or more of ALT, AST or GGT(Gamma-glutamyl transpeptidase) : = the upper limit of normal levels(ULN)?1.5 and < ULN?3
1) BMI: = 23kg/m2 and = 35kg/m2
2) Subjects with High quality of the meal (recommended food score > 36)
3) Subjects who constantly performed moderate exercises at least 3 months prior to the first visit
4) Chronic smoker (= 20 cigarettes/d)
5) alcoholics or Subjects who usually drink alcohol as follows
-male = 210 g / week (3.5 bottles of soju/week, 4 glasses/day)
-female = 140 g / week (2.5 bottles of soju/week, 3 glasses/day)
6) Continuous consumption of beans or bean products(tofu, soy milk, etc.) within 2 weeks before the first visit
7) Subject with following diseases and past medical history
? diseases related hepatic function
-viral hepatitis
-serious liver disease(hepatic insufficiency, etc.) primary biliary cirrhosis, drug-induced liver disease
-autoinnune liver disease
-liver disease induced by drug or operation
-inherited liver disease
? infectious disease ([tuberculosis, etc.), serious cardiovascular disease, disease of digestive system, renal disease, thyroid disease, autoimmune disease, malignant tumor, multisystem failure, Inflammatory Bowel Disease, serious mental illness,HIV positive
8) Received organ transplantation or bone marrow transplantation
9) Predicted to use prohibited drugs
10) Administration of drugs that affect liver function within 6 months before the first visit (medication for hyperlipidemia,antidiabetics, medication for chronic liver disease,hypotensive agents, high dose of estrogen, betaine, corticosteroids, pioglitazone, rosiglitazone, pentoxifylline, gemfibrozil, etc.) or administration of steroid over 14 days
11) Continuous consumption of dietary supplements or oriental medicine within 8 weeks before the first visit
12) Subjects with hypersensitivity to test materials
13) Participation in other human study within 12 weeks before the first visit
14) Pregnant or lactating women
15) 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 Hepatic function
- Secondary Outcome Measures
Name Time Method Hepatic function related markers