An interventional study of Phytosterols & placebo in Non-alcoholic Fatty Liver Disease, sponsored by China Medical University Hospital. Completed at 1 site in Taiwan. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-06-11.
Sponsored by China Medical University Hospital · Not applicable, Interventional, and Prevention
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 .
1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 1,098 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
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Exclusion Criteria:
Group A:daily 1.8g phytosterols powder for 4 weeks first;group B:placebo for 4 weeks first
Dietary Supplement: Phytosterols & placebo
Group A:Phytosterols 1.8g/day with one meal for 4 weeks first;group B:placebo first
Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: after 4 weeks phytosterols 1.8g/day
Study from Oct. to Dec.2012 in China Medical University Hospital -Taipei branch Initially,51 patients screened .Finally, 40 patients were enrolled.
| Milestone | Group A:Phytosterols-placebo | Group B:Placebo-phytosterols |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
| Milestone | Group A:Phytosterols-placebo | Group B:Placebo-phytosterols |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
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)
| mg/dl | Group A:Phytosterols-placebo | Group B:Placebo-phytosterols |
|---|---|---|
| total cholesterol (baseline) | 184.1 ± 6.54 | 191.65 ± 8.74 |
| total cholesterol (mid-point) | 174.60 ± 6.13 | 199.25 ± 6.70 |
| total cholesterol (end-point) | 180.55 ± 5.59 | 188.60 ± 6.03 |
| low density lipoprotein (baseline) | 110.33 ± 6.19 | 118.45 ± 7.86 |
| low density lipoprotein (mid-point) | 100.76 ± 5.96 | 121.29 ± 6.10 |
| low density lipoprotein (end-point) | 107.54 ± 5.05 | 112.66 ± 5.46 |
| fating glucose (baseline) | 106.23 ± 2.40 | 105.01 ± 1.80 |
| fasting glucose (mid-point) | 100.78 ± 1.88 | 104.88 ± 2.04 |
| fasting glucose (end-point) | 105.44 ± 2.36 | 101.65 ± 1.57 |
| c reactive protein (baseline) | 0.32 ± 0.07 | 0.24 ± 0.05 |
| c reactive protein (mid-point) | 0.23 ± 0.03 | 0.26 ± 0.04 |
| C reactive protein (end-point) | 0.23 ± 0.03 | 0.19 ± 0.02 |
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)
| U/mg-protein | Group A:Phytosterols-placebo | Group B:Placebo-phytosterols |
|---|---|---|
| Serum SOD (baseline) | 97.33 ± 2.67 | 99.41 ± 2.39 |
| Serum SOD (mid-point) | 104.91 ± 3.16 | 95.1 ± 2.82 |
| Serum SOD (end-point) | 103.28 ± 4.18 | 106.54 ± 3.76 |
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)
| ng/ml | Group A:Phytosterols-placebo | Group B:Placebo-phytosterols |
|---|---|---|
| Serum IGF-1 (baseline) | 137.14 ± 8.36 | 153.30 ± 10.44 |
| Serum IGF-1 (mid-point) | 167.96 ± 9.42 | 150.26 ± 9.37 |
| Serum IGF-1 (end-point) | 165.23 ± 7.78 | 178.04 ± 10.88 |
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)
| positive cells/150,000 cells | Group A:Phytosterols-placebo | Group B:Placebo-phytosterols |
|---|---|---|
| EPCs with CD34+ (baseline) | 13.5 ± 2.38 | 18.4 ± 2.58 |
| EPCs with CD34+ (mid-point) | 23.35 ± 4.88 | 18.4 ± 3.74 |
| EPCs with CD34+ (end-point) | 18.7 ± 2.31 | 28.25 ± 3.68 |
| EPCs with CD34+,KDR+ (baseline) | 0.9 ± 0.26 | 1.2 ± 0.31 |
| EPCs with CD34+,KDR+ (mid-point) | 2.5 ± 0.34 | 1.1 ± 0.16 |
| EPCs with CD34+,KDR+ (end-point) | 2.05 ± 0.23 | 2.5 ± 0.4 |
| EPCs with KDR+,CD133+ (baseline) | 0.8 ± 0.24 | 1.1 ± 0.3 |
| EPCs with KDR+,CD133+ (mid-point) | 2.45 ± 0.31 | 1.1 ± 0.16 |
| EPCs with KDR+,CD133+ (end-point) | 1.9 ± 0.26 | 2.4 ± 0.42 |
Collected over 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A: Phytosterols-placebo | — | 0/20 (0%) | 1/20 (5%) |
| Group B: Placebo-phytosterols | — | 0/20 (0%) | 0/20 (0%) |
| Event | Group A: Phytosterols-placebo | Group B: Placebo-phytosterols |
|---|---|---|
| Serious adverse event in the end of first interventionVascular disorders | 0/20 | 0/20 |
| Serious adverse event in the end of second interventionVascular disorders | 0/20 | 0/20 |
| Event | Group A: Phytosterols-placebo | Group B: Placebo-phytosterols |
|---|---|---|
| diarrhea in the end of first interventionGastrointestinal disorders | 1/20 | 0/20 |
| diarrhea in the end of second interventionGastrointestinal disorders | 0/20 | 0/20 |
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.
| Age, Categorical(Participants) | Group A:Phytosterols-placebo | Group B:Placebo-phytosterols | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 18 | 37 |
| >=65 years | 1 | 2 | 3 |
| Age, Continuous(years) | Group A:Phytosterols-placebo | Group B:Placebo-phytosterols | Total |
|---|---|---|---|
| Mean | 51 ± 12 | 51 ± 18 | 51 ± 12 |
| Sex: Female, Male(Participants) | Group A:Phytosterols-placebo | Group B:Placebo-phytosterols | Total |
|---|---|---|---|
| Female | 10 | 9 | 19 |
| Male | 10 | 11 | 21 |
| Region of Enrollment(participants) | Group A:Phytosterols-placebo | Group B:Placebo-phytosterols | Total |
|---|---|---|---|
| Taiwan | 20 | 20 | 40 |
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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