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
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.
Fatty liver is the hepatic feature of metabolic syndrome. Metabolic syndrome increase the
risk of atherosclerosis and cardiovascular disease. Adipose tissue secrete adipocytes
accumulate in the liver result in fatty liver. Excess fat become low density
lipoprotein-cholesterol(LDL-C) from liver. Oxidized- LDL-C adherence in the vessel result in
atherosclerosis via inflammation and immune response.
Phytosterols are present in the nuts, plant oil, broccoli and so on. The structure of
phytosterols are similar with cholesterols. After the competition, the smaller absorption of
cholesterols. Studies showed the average consumptions of phytosterols were 200mg daily but
the enough amount for cardiovascular protection of phytosterols were 2000mg daily.
Daily 2000mg phytosterols inhibit the absorption of intestine, reduce the LDL-C about 7-10%.
Besides, phytosterols have the effect of anti-inflammation and anti-immune response. The
anti-inflammation effect obvious inhibit the monocyte to transform to macrophage, inhibit
the formation of foam cell.
Clinical studies divided into two groups: 20/20 patients and 4 weeks follow up with
cross-over test.First group A: Phytosterols 1800mg/day for 4 weeks ,washout 2 weeks, then
placebo 4 weeks. Another group B: placebo 4 weeks, washout 2 weeks, then phytosterols 4
weeks.Cross-over, double blind study was designed.
Investigators check the possible benefits of LDL-C, Total -cholesterol,anti-oxidant
capacity,C reactive protein,insulin-like growth factor-1, endothelial progenitor cells ; the
possible side effect including liver function,muscle enzyme .
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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