A human study to determine effective dose of purple sweet potato extract for investigation of hepatoprotective and antioxidative effects in subject with fatty liver

Not Applicable

Completed

• Conditions: Not Applicable

• Registration Number: KCT0000747
• Lead Sponsor: Ewha Womans University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) Subject who voluntarily agrees to participate and signs in informed consent form
2) Age: = 20 years
3) Subject with fatty liver (confirmed by ultrasonography)

Exclusion Criteria

1) BMI = 35kg/m2
2) Chronic smoker (= 20 cigarettes/d)
3) Alcohol consumption (men: = 30g/d, women: = 15g/d)
4) Subject with following diseases and past medical history
? Related to Liver Function : viral hepatitis, liver dysfunction, serious liver disease, primary biliary cirrhosis, drug-induced liver disease, autoinnune liver disease, inherited liver disease
? General infectious disease (included tuberculosis), serious CVD, renal disease, thyroid disease, autoimmune disease, malignant tumor, multisystem failure, ulcerative colitis, uncontrolled mental illness, HIV
5) Received organ transplantation or bone marrow transplantation
6) Predicted to use prohibited drugs
7) Administration of drugs that affect liver function within 6 months before the first visit (UDCA, statin, hypolipidemic, hypoglycemic, drugs for chronic liver disease, hypotensive, high-dose of estrogen, betaine, corticosteroids, pioglitazone, rosiglitazone, pentoxifylline, gemfibrozil) or administration of steroid over 14 days
8) Consumption of dietary supplements or oriental medicine that affect liver function and antioxidative capacity within 8 weeks before the first visit
9) Subjects with hypersensitivity to test materials
10) Participation in other human study within 12 weeks before the first visit
11) Pregnant or lactating women
12) 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
Markers of hepatic function and antioxidative capacity

Secondary Outcome Measures

Name	Time	Method
ipid profiles, etc.