The aim of this study is effects of Green Tea supplementation on liver enzymea,lipid profile and Fasting Blood Sugare. 70 Men and women 20-60 years with fatty liver and Alanine amino Transferase equal or higher than 40, allocated into intervention and control groups and respectively recieved Green Tea and placebo. It is randomized and double blind trial. exclusion criteria are kidny diseases; chronic lung disease; other hepatic disease and alcoholism. variables are Alanin amino Transferase; Aspartat amino Transferase; Low Density Lipoprotein; High Density Lipoprotein; ; Fasting Blood Sugar; Cholesterol; Triglyceride.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013092611763N12
Registration date:2014-08-22, 1393/05/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-22, 1393/05/31
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science
Expected recruitment start date
2014-01-17, 1392/10/27
Expected recruitment end date
2014-03-18, 1392/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Green Tea supplementation on liver enzymes , lipid profile and fasting blood glucose in patients of non-alcoholic fatty liver disease
Public title
fatty liver and Green Tea
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:adults (men &women)20-60 years with fatty live and Alanine amino Transferase equal or higher than 40. exclusion criteria:kidny diseases, chronic lung disease, other hepatic disease, alcoholism.
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University Of Medical Sicences
Street address
Hezar Jarib Street
City
Isfahan
Postal code
81745-313
Approval date
2013-11-29, 1392/09/08
Ethics committee reference number
393254
Health conditions studied
1
Description of health condition studied
non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
LDL
Timepoint
befor and 3 month after intervention
Method of measurement
photometric
2
Description
Chol
Timepoint
befor and 3 month after intervention
Method of measurement
photometric
3
Description
AST
Timepoint
befor and 3 month after intervention
Method of measurement
photometric
4
Description
TG
Timepoint
befor and 3 month after intervention
Method of measurement
photometric
5
Description
ALT
Timepoint
befor and 3 month after intervention
Method of measurement
photometric
6
Description
HDL
Timepoint
befor and 3 month after intervention
Method of measurement
photometric
7
Description
FBS
Timepoint
befor and 3 month after intervention
Method of measurement
photometric
Secondary outcomes
1
Description
weight
Timepoint
befor and after 3 month of intervention
Method of measurement
scale
2
Description
waist circumference
Timepoint
befor and 3 month of intervention
Method of measurement
meter
3
Description
hip circumference
Timepoint
befor and 3 month after intervention
Method of measurement
meter
Intervention groups
1
Description
intervention groups:1 capsol of 500 miligrames Green Tea in a day for 3 months
Category
Other
2
Description
control groups: 1 capsol of lactose in a day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology & Metabolism Research Institute
Full name of responsible person
gholamreza askari
Street address
jomhouri eslami square- khoram Street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Siciences
Full name of responsible person
gholamreza askari
Street address
Hezar Jarib Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Siciences
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
Isfahan University of Medical Sciences
Full name of responsible person
gholamreza askari
Position
Ph.D of Nurition Sciences
Other areas of specialty/work
Street address
Hezar Jarib Street
City
Isfahan
Postal code
Phone
+98 31 4792 2658
Fax
Email
askari@mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Ph.D of Nurition Sciences
Other areas of specialty/work
Street address
Hezar Jarib Street
City
Isfahan
Postal code
Phone
+98 31 4792 2658
Fax
Email
askari@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Ph.D of Nutrition Sciences
Other areas of specialty/work
Street address
Hezar Jarib Street
City
Isfahan
Postal code
Phone
+98 31 4792 2658
Fax
Email
askari@mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)