A human study for evaluating effectiveness and safety of barley sprout extracts consumption on alcoholic liver damage

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002891

Enrollment

Registered

2018-05-24

Start date

2017-09-18

Completion date

Unknown

Last updated

2021-06-24

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 : Subject who voluntarily agree to participate and signs informed consent form at visit1(0week) are diagnosed whether they are suitable or not by inclusive and exclusive criteria. T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subject who voluntarily agree to participate and signs informed consent form 2) 20 years= Age (Ratio of men and women 1:1) 3) Have been drinking alcohol more than a year as follows: - Men: more than 140g/week( about 2.5 bottle as Soju, 2.5glass/day) - Women: more than 70g/week( about a bottle as Soju, 1 glass/day) 4) Comply one of the following conditions - more than upper llimit of AST, AST:ALT ratio is 1 - more than upper llimit of GGT 5) Confirmed a fatty liver

Exclusion criteria

Exclusion criteria: 1) Usually drinking alcohol more than 350g/week( about 6 bottles/week, 6 glasses/day) 2) Exceed 3 times of normal upper limit more than one of the following categories: AST, ALT, GGT, total bilirubin 3) Have anamnesis in following diseases ? Related to liver function - post-transfusion hepatitis (hepatitis B surface antigen(HBsAg) or type C) - hepatic insufficiency, primary biliary cirrhosis - drug or surgery induced hepatitis - genetic liver disease ? whole body infectious disease (include tuberculosis), serious cardiovascular or digestive system, thyroid disease, autoimmune disease, malignant tumor, multisystem failure, inflammatory enteropathy, a mental patient, confirmed as HIV-positive.4) Medical history of organ transplant or bone-marrow transplantation 5) Consumption of sprout foods within 2 weeks before the first visit 6) Consumption of prohibit drugs within 6 months before the first visit or have potential to take during the study period 7) Continuous consumption of dietary supplement or oriental medicine or sobering drinks that affect liver function, inflammation, antioxidative capacity 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

Design outcomes

Primary

Measure	Time frame
Liver function biomarkers	—

Secondary

Measure	Time frame
Liver function related metabolic biomarkers	—

Countries

Korea, Republic of

Contacts

Public ContactYunsoo Kim

Ewha Womans University

sookim726@gmail.com+82-2-3277-3087

Outcome results