Clinical Trial: Effect of Phytosterols on Nonalcoholic Fatty Liver Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Study of Phytosterols for Insulin-like Growth Factor-1 and Endothelial Progenitor Cell Levels in Patients With Nonalcoholic Fatty Liver Disease

Brief 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.

Detailed Summary:

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 .


Sponsor: China Medical University Hospital

Current Primary Outcome:

  • Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease [ Time Frame: after 4 weeks phytosterols 1.8g/day ]
    1. Check serum metabolic status: levels in total cholesterol, low density lipoprotein-cholesterol, fasting glucose
    2. 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)

  • Anti-oxidative Capacity of Phytosterols on Patients With Fatty Liver Disease [ Time Frame: after 4 weeks phytosterols 1.8g/day ]

    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)

  • Insulin-like Growth Factor-1 Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease [ Time Frame: after 4 weeks phytosterols 1.8g/day ]

    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.