Protocol summary

Summary
main objective of this study is to investigate Effects of Extra Virgin Olive Oil on Serum TNFα , Hepatic enzymes(ALT , AST) ,Lipoproteins، ،Insulin resistance، ، Anthropometric measurments and Esteatosis severity in Non – alcoholic Fatty Liver Patients and Loss Weight Diet . In this clinical trial, men and women (n=50), aged 20-60 years old who referred to clinics of mazandaran university of medical sciences in sari ,will be randomly assigned into olive oil(receiving the equivalent of 20% of total daily energy requirement from olive oil ) or control group ( receiving their usual consumption of oil )for 12 weeks.10 days before the start of intervention patients will be asked not to consume olive oil . All the patients in both groups will receive a hypo caloric diet for 90 days according to their weight, age and sex .information about anthropometric measurments (weight , waist circumference ,BMI , percent body fat ) and three - day 24 hour dietary recall will beobtained at the beginning of the study and the end of each month. physical activity , serum TNFα, liver enzymes (ALT,AST ),lipoproteins profile, fasting glucose, insulin resistance and Esteatosis severity will be determined at the baseline and after 12 weeks

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111022709N20
Registration date: 2011-12-26, 1390/10/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-26, 1390/10/05
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Extra Virgin Olive Oil on Serum Hepatic enzymes ،Insulin resistance، Lipoproteins، TNFα ، Anthropometric measurments and Esteatosis severity in Non – alcoholic Fatty Liver Patients Whit Loss Weight Diet
Public title
" effects of Olive Oil in non-alcoholic fatty liver disease patients"
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculty of Public Health of Tehran University of Medical Sciences
Street address
Number 60, Alvand street, Argentina square, Tehran
City
TEHRAN
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
130,1872,ص 90

Health conditions studied

1

Description of health condition studied
non-alcoholic fatty liver
ICD-10 code
k76.0
ICD-10 code description
Fatty ( change of ) liver , not elsewhere classified

Primary outcomes

1

Description
serum ALT
Timepoint
BEFORE AND END OF INTERVENTION
Method of measurement
IFCC,IU/D

2

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

3

Description
steatosis severity
Timepoint
BEFORE AND END OF INTERVENTION
Method of measurement
Sonography

Secondary outcomes

1

Description
TNF α
Timepoint
BEFORE AND END OF INTERVENTION
Method of measurement
ELISA5,Pg/L

2

Description
fasting TG
Timepoint
BEFORE AND END OF INTERVENTION
Method of measurement
enzymetic method , mg / dl

3

Description
insulin resistance
Timepoint
BEFORE AND END OF INTERVENTION
Method of measurement
calculation

4

Description
fasting insulin
Timepoint
BEFORE AND END OF INTERVENTION
Method of measurement
Immunoassay radiometer,ΜU / ml

5

Description
fastingGlucose
Timepoint
BEFORE AND END OF INTERVENTION
Method of measurement
Colorimetric method.mg / dl

6

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

7

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

8

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

9

Description
percent body weight
Timepoint
BEFORE AND END OF INTERVENTION
Method of measurement
Caliper, percent

10

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

11

Description
waist circumference
Timepoint
BEFORE AND END OF INTERVENTION
Method of measurement
TAPE , Cm

Intervention groups

1

Description
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
Category
Treatment - Other

2

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

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam KHomeini therapeutic educational center
Full name of responsible person
Dr Tarang Taghvai, Professor of mazandaran university of medical sciences,Gastroenterologist
Street address
Sari- Amir mazandarani street. Emam KHomeini Hospital
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fottohi
Street address
Keshavarz Bld - intersection of Qods street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Public Health of Tehran University of Medical Sciences
Full name of responsible person
Dr Farzad Shidfar
Position
Professor /nutrition PhD
Other areas of specialty/work
Street address
Number 60, Alvand street, Argentina square, Tehran
City
Tehran
Postal code
1516846515
Phone
+98 21 8877 9118
Fax
Email
farzadshidfar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Public Health of Tehran University of Medical Sciences
Full name of responsible person
Dr Farzad Shidfar
Position
Professor /nutrition PhD
Other areas of specialty/work
Street address
Number 60, Alvand street, Argentina square, Tehran
City
Tehran
Postal code
1516846515
Phone
+98 21 8877 9118
Fax
Email
farzadshidfar@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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