Trial Outcomes & Findings for Effect of Phytosterols on Nonalcoholic Fatty Liver Disease (NCT NCT01875978)
NCT ID: NCT01875978
Last Updated: 2014-06-11
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
after 4 weeks phytosterols 1.8g/day
Results posted on
2014-06-11
Participant Flow
Study from Oct. to Dec.2012 in China Medical University Hospital -Taipei branch Initially,51 patients screened .Finally, 40 patients were enrolled.
Statins, red yeast rice, omega-3 ,fibrates were excluded.
Participant milestones
| Measure |
Group A:Phytosterols-placebo
phytosterols 1.8g/day first, then placebo.
|
Group B:Placebo-phytosterols
Placebo first, then phytosterols 1.8g/day
|
|---|---|---|
|
Study 4weeks
STARTED
|
20
|
20
|
|
Study 4weeks
COMPLETED
|
20
|
20
|
|
Study 4weeks
NOT COMPLETED
|
0
|
0
|
|
Washout 2 Weeks ,Crossover Study 4 Weeks
STARTED
|
20
|
20
|
|
Washout 2 Weeks ,Crossover Study 4 Weeks
COMPLETED
|
20
|
20
|
|
Washout 2 Weeks ,Crossover Study 4 Weeks
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Phytosterols on Nonalcoholic Fatty Liver Disease
Baseline characteristics by cohort
| Measure |
Group A:Phytosterols-placebo
n=20 Participants
Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
|
Group B:Placebo-phytosterols
n=20 Participants
Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 12 • n=5 Participants
|
51 years
STANDARD_DEVIATION 18 • n=7 Participants
|
51 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after 4 weeks phytosterols 1.8g/day1. 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)
Outcome measures
| Measure |
Group A:Phytosterols-placebo
n=20 Participants
Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
|
Group B:Placebo-phytosterols
n=20 Participants
Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
|
|---|---|---|
|
Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
total cholesterol (baseline)
|
184.1 mg/dl
Standard Error 6.54
|
191.65 mg/dl
Standard Error 8.74
|
|
Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
total cholesterol (mid-point)
|
174.60 mg/dl
Standard Error 6.13
|
199.25 mg/dl
Standard Error 6.70
|
|
Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
total cholesterol (end-point)
|
180.55 mg/dl
Standard Error 5.59
|
188.60 mg/dl
Standard Error 6.03
|
|
Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
low density lipoprotein (baseline)
|
110.33 mg/dl
Standard Error 6.19
|
118.45 mg/dl
Standard Error 7.86
|
|
Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
low density lipoprotein (mid-point)
|
100.76 mg/dl
Standard Error 5.96
|
121.29 mg/dl
Standard Error 6.10
|
|
Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
low density lipoprotein (end-point)
|
107.54 mg/dl
Standard Error 5.05
|
112.66 mg/dl
Standard Error 5.46
|
|
Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
fating glucose (baseline)
|
106.23 mg/dl
Standard Error 2.40
|
105.01 mg/dl
Standard Error 1.80
|
|
Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
fasting glucose (mid-point)
|
100.78 mg/dl
Standard Error 1.88
|
104.88 mg/dl
Standard Error 2.04
|
|
Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
fasting glucose (end-point)
|
105.44 mg/dl
Standard Error 2.36
|
101.65 mg/dl
Standard Error 1.57
|
|
Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
c reactive protein (baseline)
|
0.32 mg/dl
Standard Error 0.07
|
0.24 mg/dl
Standard Error 0.05
|
|
Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
c reactive protein (mid-point)
|
0.23 mg/dl
Standard Error 0.03
|
0.26 mg/dl
Standard Error 0.04
|
|
Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
C reactive protein (end-point)
|
0.23 mg/dl
Standard Error 0.03
|
0.19 mg/dl
Standard Error 0.02
|
PRIMARY outcome
Timeframe: after 4 weeks phytosterols 1.8g/dayCheck 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)
Outcome measures
| Measure |
Group A:Phytosterols-placebo
n=20 Participants
Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
|
Group B:Placebo-phytosterols
n=20 Participants
Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
|
|---|---|---|
|
Anti-oxidative Capacity of Phytosterols on Patients With Fatty Liver Disease
Serum SOD (baseline)
|
97.33 U/mg-protein
Standard Error 2.67
|
99.41 U/mg-protein
Standard Error 2.39
|
|
Anti-oxidative Capacity of Phytosterols on Patients With Fatty Liver Disease
Serum SOD (mid-point)
|
104.91 U/mg-protein
Standard Error 3.16
|
95.1 U/mg-protein
Standard Error 2.82
|
|
Anti-oxidative Capacity of Phytosterols on Patients With Fatty Liver Disease
Serum SOD (end-point)
|
103.28 U/mg-protein
Standard Error 4.18
|
106.54 U/mg-protein
Standard Error 3.76
|
PRIMARY outcome
Timeframe: after 4 weeks phytosterols 1.8g/dayCheck 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)
Outcome measures
| Measure |
Group A:Phytosterols-placebo
n=20 Participants
Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
|
Group B:Placebo-phytosterols
n=20 Participants
Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
|
|---|---|---|
|
Insulin-like Growth Factor-1 Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
Serum IGF-1 (baseline)
|
137.14 ng/ml
Standard Error 8.36
|
153.30 ng/ml
Standard Error 10.44
|
|
Insulin-like Growth Factor-1 Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
Serum IGF-1 (mid-point)
|
167.96 ng/ml
Standard Error 9.42
|
150.26 ng/ml
Standard Error 9.37
|
|
Insulin-like Growth Factor-1 Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
Serum IGF-1 (end-point)
|
165.23 ng/ml
Standard Error 7.78
|
178.04 ng/ml
Standard Error 10.88
|
PRIMARY outcome
Timeframe: after 4 weeks phytosterols 1.8g/dayCeck 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)
Outcome measures
| Measure |
Group A:Phytosterols-placebo
n=20 Participants
Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
|
Group B:Placebo-phytosterols
n=20 Participants
Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
|
|---|---|---|
|
Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease
EPCs with CD34+ (baseline)
|
13.5 positive cells/150,000 cells
Standard Error 2.38
|
18.4 positive cells/150,000 cells
Standard Error 2.58
|
|
Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease
EPCs with CD34+ (mid-point)
|
23.35 positive cells/150,000 cells
Standard Error 4.88
|
18.4 positive cells/150,000 cells
Standard Error 3.74
|
|
Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease
EPCs with CD34+ (end-point)
|
18.7 positive cells/150,000 cells
Standard Error 2.31
|
28.25 positive cells/150,000 cells
Standard Error 3.68
|
|
Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease
EPCs with CD34+,KDR+ (baseline)
|
0.9 positive cells/150,000 cells
Standard Error 0.26
|
1.2 positive cells/150,000 cells
Standard Error 0.31
|
|
Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease
EPCs with CD34+,KDR+ (mid-point)
|
2.5 positive cells/150,000 cells
Standard Error 0.34
|
1.1 positive cells/150,000 cells
Standard Error 0.16
|
|
Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease
EPCs with CD34+,KDR+ (end-point)
|
2.05 positive cells/150,000 cells
Standard Error 0.23
|
2.5 positive cells/150,000 cells
Standard Error 0.4
|
|
Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease
EPCs with KDR+,CD133+ (baseline)
|
0.8 positive cells/150,000 cells
Standard Error 0.24
|
1.1 positive cells/150,000 cells
Standard Error 0.3
|
|
Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease
EPCs with KDR+,CD133+ (mid-point)
|
2.45 positive cells/150,000 cells
Standard Error 0.31
|
1.1 positive cells/150,000 cells
Standard Error 0.16
|
|
Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease
EPCs with KDR+,CD133+ (end-point)
|
1.9 positive cells/150,000 cells
Standard Error 0.26
|
2.4 positive cells/150,000 cells
Standard Error 0.42
|
Adverse Events
Group A: Phytosterols-placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group B: Placebo-phytosterols
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Phytosterols-placebo
n=20 participants at risk
Daily 1.8g phytosterols powder for 4 weeks, washout 2 weeks, then placebo for 4 weeks
|
Group B: Placebo-phytosterols
n=20 participants at risk
placebo for 4 weeks, washout 2 weeks. then daily 1.8 g phytosterols for 4 weeks
|
|---|---|---|
|
Vascular disorders
Serious adverse event in the end of first intervention
|
0.00%
0/20 • 2 months
study 4 weeks, washout 2 weeks, then cross over study 4 weeks
|
0.00%
0/20 • 2 months
study 4 weeks, washout 2 weeks, then cross over study 4 weeks
|
|
Vascular disorders
Serious adverse event in the end of second intervention
|
0.00%
0/20 • 2 months
study 4 weeks, washout 2 weeks, then cross over study 4 weeks
|
0.00%
0/20 • 2 months
study 4 weeks, washout 2 weeks, then cross over study 4 weeks
|
Other adverse events
| Measure |
Group A: Phytosterols-placebo
n=20 participants at risk
Daily 1.8g phytosterols powder for 4 weeks, washout 2 weeks, then placebo for 4 weeks
|
Group B: Placebo-phytosterols
n=20 participants at risk
placebo for 4 weeks, washout 2 weeks. then daily 1.8 g phytosterols for 4 weeks
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea in the end of first intervention
|
5.0%
1/20 • Number of events 1 • 2 months
study 4 weeks, washout 2 weeks, then cross over study 4 weeks
|
0.00%
0/20 • 2 months
study 4 weeks, washout 2 weeks, then cross over study 4 weeks
|
|
Gastrointestinal disorders
diarrhea in the end of second intervention
|
0.00%
0/20 • 2 months
study 4 weeks, washout 2 weeks, then cross over study 4 weeks
|
0.00%
0/20 • 2 months
study 4 weeks, washout 2 weeks, then cross over study 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60