" effects of Olive Oil in non-alcoholic fatty liver disease patients"

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT201111022709N20
• Date of registration: 2011-12-26
• Prospective Registration: No
• Primary sponsor: Vice-chancellor for Research, Tehran University of Medical Sciences
• Public title: " effects of Olive Oil in non-alcoholic fatty liver disease patients"
• Scientific title: Effects of Extra Virgin Olive Oil on Serum Hepatic enzymes ?Insulin resistance? Lipoproteins? TNFa ? Anthropometric measurments and Esteatosis severity in Non – alcoholic Fatty Liver Patients Whit Loss Weight Diet
• Date of first enrolment: 2011-11-22
• Target sample size: 50
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/2533
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Dr Farzad Shidfar
• Affiliation: Faculty of Public Health of Tehran University of Medical Sciences

• Name: Dr Farzad Shidfar
• Affiliation: Faculty of Public Health of Tehran University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion Criteria: signing written informed consent, age between 20and 60, diagnosis of non-alcoholic fatty liver disease by fatty infiltration on ultrasound and abnormal serum liver function tests (AST or ALT>30 u/l in men and >20 in women), no smoking, BMI between 25 to 35, no pregnancy or lactation, no use of dietary supplements 2 month prior to enrollment, not having diabetes, , acute heart disease, , other form of liver disease (viral or autoimmune hepatitis, metabolic and hereditary liver disease), no usual use of Olive Oil in dietary pattern, no use of drugs that induces steatosis (amidarone, methotrexate, systemic glucocorticoid, tetracycline, tamoxifen, estrogen, anabolic steroids, valporic acid) , no use of Lipid lowering drugs . Exclusion Criteria: those who are not interested in participating in the study, start using drugs affecting liver functiont, failure to complete or correct use of Olive Oil according to the instruction given , change in recommended diet and daily physical activity
Exclusion criteria:

Age minimum: 20 years
Age maximum: 60 years
Gender: Both

Health Condition(s) or Problem(s) studied

non-alcoholic fatty liver.
Fatty ( change of ) liver , not elsewhere classified

Fatty ( change of ) liver , not elsewhere classified

Intervention(s)

Treatment - Other

control group :( not application )20% of total daily energy requirement from usual daily consumption of oil for 12 weeks

Intervention 1: intervention group :Extra Virgin Olive Oil, 20% of total daily energy requirement olive will be replaced with usual daily consumption of oil for every patients for 12 weeks. Intervention 2: control group :( not application )20% of total daily energy requirement from usual daily consumption of oil for 12 weeks.

intervention group :Extra Virgin Olive Oil, 20% of total daily energy requirement olive will be replaced with usual daily consumption of oil for every patients for 12 weeks

Primary Outcome(s)

Serum ALT. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: IFCC,IU/D.

Steatosis severity. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: Sonography.

Sserum AST. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: IFCC,IU/D.

Secondary Outcome(s)

Waist circumference. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: TAPE , Cm.

HDL - C. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: enzymetic method , mg / dl.

Fasting insulin. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: Immunoassay radiometer,?U / ml.

Insulin resistance. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: calculation.

Percent body weight. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: Caliper, percent.

LDL - C. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: enzymetic method , mg / dl.

TNF a. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: ELISA5,Pg/L.

BMI. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: calculation,Kg / m2.

Fasting TG. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: enzymetic method , mg / dl.

FastingGlucose. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: Colorimetric method.mg / dl.

Total cholestrol. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: enzymetic method , mg / dl.

Source(s) of Monetary Support

Vice-chancellor for Research, Tehran University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Faculty of Public Health of Tehran University of Medical Sciences