Effect of Phytosterols on Nonalcoholic Fatty Liver Disease
Clinical Study of Phytosterols for Insulin-like Growth Factor-1 and Endothelial Progenitor Cell Levels in Patients With Nonalcoholic Fatty Liver Disease
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 3, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
June 11, 2014
CompletedJune 11, 2014
May 1, 2014
2 months
June 3, 2013
November 7, 2013
May 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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)
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)
after 4 weeks phytosterols 1.8g/day
Study Arms (1)
Phytosterols & placebo
ACTIVE COMPARATORGroup A:daily 1.8g phytosterols powder for 4 weeks first;group B:placebo for 4 weeks first
Interventions
Group A:Phytosterols 1.8g/day with one meal for 4 weeks first;group B:placebo first
Eligibility Criteria
You may qualify if:
- (1)25-80 years
- (2)Fatty liver was diagnosed by abdominal echo by the same gastrologist, review by another gastrologist
You may not qualify if:
- (1)Serological markers of hepatitis B virus(hepatitis B surface antigen and anti-HBs antibody) and hepatitis C virus infection (anti-HCV antibody)
- (2)Autoimmune liver disease or alcoholic liver disease(alcohol intake more than 20g per day by using a questionnaire)
- (3)Malignant diseases
- (4)Pregnancy or breast feeding
- (5)Clinical evidence of angina, congestive heart failure, valvular heart disease, inflammatory disease or thyroid dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
1. The sample size of this study is small amount 2. Abdominal ultrasound related nonalcoholic fatty liver disease diagnosis is not compatible completely
Results Point of Contact
- Title
- Dr. Dalong Chen
- Organization
- China Medical University Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Dalong Chen, M.D.
China Medical University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2013
First Posted
June 12, 2013
Study Start
October 1, 2012
Primary Completion
December 1, 2012
Study Completion
July 1, 2013
Last Updated
June 11, 2014
Results First Posted
June 11, 2014
Record last verified: 2014-05