N/A
Completed N=40
Effect of Phytosterols on Nonalcoholic Fatty Liver Disease
Source: ClinicalTrials.gov NCT01875978 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease — 184.1; 191.65; 174.60; 199.25 mg/dl — p=<0.05
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease |
184.1; 191.65; 174.60; 199.25; 180.55; 188.60 | <0.05 sig |
| PRIMARY Anti-oxidative Capacity of Phytosterols on Patients With Fatty Liver Disease |
97.33; 99.41; 104.91; 95.1; 103.28; 106.54 | <0.05 sig |
| PRIMARY Insulin-like Growth Factor-1 Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease |
137.14; 153.30; 167.96; 150.26; 165.23; 178.04 | <0.05 sig |
| PRIMARY Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease |
13.5; 18.4; 23.35; 18.4; 18.7; 28.25 | <0.05 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01875978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.