Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
Clinical Study of Phytosterols for Insulin-like Growth Factor-1 and Endothelial Progenitor Cell Levels in Patients With Nonalcoholic Fatty Liver Disease
Verified date | May 2014 |
Source | China Medical University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
Phytosterols are plant sterols . Phytosterols have anti-inflammation effect. Investigators have a hypothesis: phytosterols reduce oxidative stress , enhance Insulin-like growth factor-1(IGF-1) and endothelial progenitor cells(EPCs). Therefore, phytosterols has novel role in cardiovascular protection.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years to 80 Years |
Eligibility |
Inclusion Criteria: - (1)25-80 years - (2)Fatty liver was diagnosed by abdominal echo by the same gastrologist, review by another gastrologist Exclusion Criteria: - (1)Serological markers of hepatitis B virus(hepatitis B surface antigen and anti-HBs antibody) and hepatitis C virus infection (anti-HCV antibody) - (2)Autoimmune liver disease or alcoholic liver disease(alcohol intake more than 20g per day by using a questionnaire) - (3)Malignant diseases - (4)Pregnancy or breast feeding - (5)Clinical evidence of angina, congestive heart failure, valvular heart disease, inflammatory disease or thyroid dysfunction |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Taiwan | China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
China Medical University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease | Check serum metabolic status: levels in total cholesterol, low density lipoprotein-cholesterol, fasting glucose Check serum anti-inflammatory status: levels in C reactive protein Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols) |
after 4 weeks phytosterols 1.8g/day | No |
Primary | Anti-oxidative Capacity of Phytosterols on Patients With Fatty Liver Disease | Check serum anti-oxidative capacity, especially the serum superoxide dismutase (SOD) levels.Serum SOD provide the anti-oxidative capacity in lipid oxidation. Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols) |
after 4 weeks phytosterols 1.8g/day | No |
Primary | Insulin-like Growth Factor-1 Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease | Check serum Insulin-like growth factor-1 levels. Serum Insulin-like growth factor-1 (IGF-1) influence metabolic status and reduce EPCs apoptosis via IGF-1 receptor. Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols) |
after 4 weeks phytosterols 1.8g/day | No |
Primary | Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease | Ceck serum endothelial progenitor cells in the monocytes group but not in the lymphocytes group. Serum EPCs in the monocytes group provide the effect of endothelial repair to support novel vessel protection. Cytometry flow check 150,000 cells per time including monocytes and lymphocytes group. Positive cells is the EPCs in the monocytes group. Stain with KDR, call kinase insert domain receptor, also call as VEGF receptor-2. Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols) |
after 4 weeks phytosterols 1.8g/day | No |
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