- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01875978
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
Study Overview
Status
Conditions
Intervention / Treatment
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 .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taichung, Taiwan
- China Medical University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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
|
Group A:Phytosterols 1.8g/day with one meal for 4 weeks first;group B:placebo first
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
Time Frame: after 4 weeks phytosterols 1.8g/day
|
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
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) |
after 4 weeks phytosterols 1.8g/day
|
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) |
after 4 weeks phytosterols 1.8g/day
|
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) |
after 4 weeks phytosterols 1.8g/day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dalong Chen, M.D., China Medical University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMR101-IRB2-036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-alcoholic Fatty Liver Disease
-
Naga P. ChalasaniDSM Nutritional Products, Inc.CompletedNon-Alcoholic Fatty Liver Disease | Non-Alcoholic Steatohepatitis | Non-Alcoholic Fatty LiverUnited States
-
Medical College of WisconsinENDRA Life Sciences, Inc.RecruitingFatty Liver | NAFLD | Non-Alcoholic Fatty Liver Disease | Non-alcoholic Steatohepatitis | Non-alcoholic Fatty Liver | NASH | Fatty Liver DiseaseUnited States
-
Michael Ohliger, MD PhDNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingNAFLD | Non-Alcoholic Fatty Liver Disease | NASH | Non Alcoholic Fatty Liver | Non Alcoholic SteatohepatitisUnited States
-
Cairo UniversityRecruitingNon-Alcoholic Fatty Liver DiseaseEgypt
-
Nehal Abou SeadaCompletedNon-Alcoholic Fatty Liver Disease
-
Better TherapeuticsArizona Liver HealthCompletedNon-Alcoholic Fatty Liver Disease | Non-alcoholic Steatohepatitis | Non-alcoholic Fatty LiverUnited States
-
Puerta de Hierro University HospitalHospital Universitario Marqués de ValdecillaNot yet recruitingNon-Alcoholic Fatty Liver Disease | Non Alcoholic SteatohepatitisSpain
-
BASF ASUnknownNASH - Nonalcoholic Steatohepatitis | Non-Alcoholic Fatty Liver Disease | Non Alcoholic Fatty LiverUnited States
-
National University Hospital, SingaporeWilmar InternationalEnrolling by invitationNAFLD | Non-Alcoholic Fatty Liver Disease | Non-Alcoholic SteatohepatitisSingapore
-
AB Biotics, SACompletedNon Alcoholic Fatty LiverMexico
Clinical Trials on Phytosterols & placebo
-
Danone JapanCompleted
-
Danone JapanCompletedSubjects With High LDL-CholesterolJapan
-
Hoffmann-La RocheTerminatedCardiovascular DiseasePoland, United States, Switzerland, Canada, Germany
-
Puerta de Hierro University HospitalCompletedHypercholesterolemia | OsteoporosisSpain
-
University of ManitobaCompleted
-
Washington University School of MedicinePennington Biomedical Research CenterCompletedHypercholesterolemia | Coronary Heart DiseaseUnited States
-
Washington University School of MedicineNational Heart, Lung, and Blood Institute (NHLBI); Utah State UniversityCompletedHypercholesterolemia | Coronary Heart DiseaseUnited States
-
Puerta de Hierro University HospitalCompletedPostmenopausal DisorderSpain
-
University of PaviaFoundation IRCCS San Matteo HospitalRecruiting
-
Universidad de los Andes, ChileCompleted