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

A human study to determine effective dose of purple sweet potato extract for investigation of hepatoprotective and antioxidative effects in subject with fatty liver: a randomized, double-blind, placebo-controlled study (Pilot study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000747

Enrollment

Registered

2013-05-16

Start date

2013-05-02

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Consumption of placebo or purple sweet potato extract for 16 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Markers of hepatic function and antioxidative capacity	—

Secondary

Measure	Time frame
Lipid profiles, etc.	—

Countries

Korea, Republic of

Contacts

Public ContactJieun Park

Ewha Womans University

Outcome results