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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phytosterols & placebo | Active Comparator | Group A:daily 1.8g phytosterols powder for 4 weeks first;group B:placebo for 4 weeks first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phytosterols & placebo | Dietary Supplement | Group A:Phytosterols 1.8g/day with one meal for 4 weeks first;group B:placebo first |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease |
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 |
| 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalong Chen, M.D. | China Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | Taiwan |
Statins, red yeast rice, omega-3 ,fibrates were excluded.
Study from Oct. to Dec.2012 in China Medical University Hospital -Taipei branch Initially,51 patients screened .Finally, 40 patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A:Phytosterols-placebo | phytosterols 1.8g/day first, then placebo. |
| FG001 | Group B:Placebo-phytosterols | Placebo first, then phytosterols 1.8g/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study 4weeks |
| |||||||||||||
| Washout 2 Weeks ,Crossover Study 4 Weeks |
|
Fatty liver was diagnosed by abdominal echo, except hepatitis B,C,alcohol consumption. Totally 40 patients randomized divided to group A for phytosterols-placebo sequence and group B for placebo-phytosterols sequence.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A:Phytosterols-placebo | Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks |
| BG001 | Group B:Placebo-phytosterols | Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease |
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) | Posted | Mean | Standard Error | mg/dl | after 4 weeks phytosterols 1.8g/day |
|
2 months
study 4 weeks, washout 2 weeks, then cross over study 4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: Phytosterols-placebo | Daily 1.8g phytosterols powder for 4 weeks, washout 2 weeks, then placebo for 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious adverse event in the end of first intervention | Vascular disorders | Non-systematic Assessment | Group A : after phytosterols, Group B: after placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea in the end of first intervention | Gastrointestinal disorders | Systematic Assessment | Group A: after phytosterols, Group B: after placebo |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dalong Chen | China Medical University Hospital | +886-227919696 | 1205 | my686chen@gmail.com |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010840 | Phytosterols |
| ID | Term |
|---|---|
| D013261 | Sterols |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| after 4 weeks phytosterols 1.8g/day |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
|
|
|
| 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) | Posted | Mean | Standard Error | U/mg-protein | after 4 weeks phytosterols 1.8g/day |
|
|
|
|
| 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) | Posted | Mean | Standard Error | ng/ml | after 4 weeks phytosterols 1.8g/day |
|
|
|
|
| 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) | Posted | Mean | Standard Error | positive cells/150,000 cells | after 4 weeks phytosterols 1.8g/day |
|
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Group B: Placebo-phytosterols | placebo for 4 weeks, washout 2 weeks. then daily 1.8 g phytosterols for 4 weeks | 0 | 20 | 0 | 20 |
|
| Serious adverse event in the end of second intervention | Vascular disorders | Non-systematic Assessment | Group A: after placebo, Group B: after phytosterols |
|
|
| diarrhea in the end of second intervention | Gastrointestinal disorders | Non-systematic Assessment | Group A: after placebo, Group B: after phytosterols |
|
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| D011083 |
| Polycyclic Compounds |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D064209 | Phytochemicals |
| D001685 | Biological Factors |
| Serum SOD (end-point) |
|
| Serum IGF-1 (end-point) |
|
| EPCs with CD34+ (end-point) |
|
| EPCs with CD34+,KDR+ (baseline) |
|
| EPCs with CD34+,KDR+ (mid-point) |
|
| EPCs with CD34+,KDR+ (end-point) |
|
| EPCs with KDR+,CD133+ (baseline) |
|
| EPCs with KDR+,CD133+ (mid-point) |
|
| EPCs with KDR+,CD133+ (end-point) |
|