Effect of Phytosterols on Nonalcoholic Fatty Liver Disease

NCT ID: NCT01875978

Last Updated: 2014-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-07-31

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.

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 .

Conditions

Non-alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Phytosterols & placebo

Group A:daily 1.8g phytosterols powder for 4 weeks first;group B:placebo for 4 weeks first

Group Type: ACTIVE_COMPARATOR

Phytosterols & placebo

Intervention Type: DIETARY_SUPPLEMENT

Group A:Phytosterols 1.8g/day with one meal for 4 weeks first;group B:placebo first

Interventions

Phytosterols & placebo

Group A:Phytosterols 1.8g/day with one meal for 4 weeks first;group B:placebo first

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dalong Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

DMR101-IRB2-036

Identifier Type: -

Identifier Source: org_study_id