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Effect of Phytosterols on Nonalcoholic Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT01875978
Recruitment Status : Completed
First Posted : June 12, 2013
Results First Posted : June 11, 2014
Last Update Posted : June 11, 2014
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Dietary Supplement: Phytosterols & placebo Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Clinical Study of Phytosterols for Insulin-like Growth Factor-1 and Endothelial Progenitor Cell Levels in Patients With Nonalcoholic Fatty Liver Disease
Study Start Date : October 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : July 2013


Arm Intervention/treatment
Active Comparator: Phytosterols & placebo
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




Primary Outcome Measures :
  1. 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)


  2. 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)


  3. 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.

    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)


  4. Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease [ Time Frame: after 4 weeks phytosterols 1.8g/day ]

    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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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1)25-80 years
  • (2)Fatty liver was diagnosed by abdominal echo by the same gastrologist, review by another gastrologist

Exclusion Criteria:

  • (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875978


Locations
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Taiwan
China Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: Dalong Chen, M.D. China Medical University Hospital

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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01875978     History of Changes
Other Study ID Numbers: DMR101-IRB2-036
First Posted: June 12, 2013    Key Record Dates
Results First Posted: June 11, 2014
Last Update Posted: June 11, 2014
Last Verified: May 2014

Keywords provided by China Medical University Hospital:
Phytosterols
Endothelial progenitor cells

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases