The aim of this study is to assess the effect of genistein supplementation on glycemic state, insulin resistance and adipose tissue in non alcoholic fatty liver patients. This randomized, double-blind, placebo-controlled will be single center study. This study is in phase 3 of clinical trial. Adult volunteers between 18 and 70 whom their fatty liver were confirmed by ultrasonography and don't have any Acute or chronic disease of the liver or bile ducts will be recruited. Exclusion criteria is severe weight loss or gain, pregnancy, ALT serum level 10 times more than normal range during study. Patients will receive 250 mg genistein or placebo once a day for 8 weeks. Patients will have a pre and post treatment laboratory evaluation including measurements of serum FBS, insulin, HOMA-IR and body fat mass (by BIA), waist circumference, weight and height.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506222480N6
Registration date:2015-07-12, 1394/04/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-12, 1394/04/21
Registrant information
Name
Mohammad Hassan Eftekhari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
eftekharim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University Of Medical Scienses
Expected recruitment start date
2015-07-06, 1394/04/15
Expected recruitment end date
2015-11-05, 1394/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of genistein supplementation on glycemic state, insulin resistance and adipose tissue in non alcoholic fatty liver patients
Public title
Treatment of non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Volunteers whom their fatty liver were confirmed by ultrasonography; Don't have any Acute or chronic disease of the liver or bile ducts
Exclusion criteria: Severe weight loss or gain; Pregnancy; ALT serum level 10 times more than normal range.
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, central building, Zand St, In Front of Felestin St
City
Shiraz
Postal code
7134814336
Approval date
2015-06-21, 1394/03/31
Ethics committee reference number
IR.SUMS.REC.1394.43
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
Insulin
Timepoint
Before intervention and two months after intervention inception
Method of measurement
By serum analysis
2
Description
FBS
Timepoint
Before intervention and two months after intervention inception
Method of measurement
By serum analysis
3
Description
Fat mass
Timepoint
Before intervention and two months after intervention inception
Method of measurement
By BIA device
Secondary outcomes
1
Description
HOMA-IR
Timepoint
Before and two months after intervention inception
Method of measurement
Calculate by HOMA index equation
Intervention groups
1
Description
wheat starch in capsule once a day for 8 weeks
Category
Placebo
2
Description
250 mg genistein as capsule once per day for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Sasan Amanat
Street address
Next to the Medicine Faculty, Karimkhan Zand Blvd
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
7th floor, Shiraz University Of Medical Sciences central building, next to Geneva Cross, Zand st.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sasan Amanat
Position
Msc student of Nutrition
Other areas of specialty/work
Street address
Nutrition and Food Sciences faculty, Razi blvd
City
Shiraz
Postal code
7433179144
Phone
+98 717251008
Fax
Email
snatm69@gmail.com
Web page address
scnutrition.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Dr. Mohammad Hassan Eftekhari
Position
Professor of Nutrition
Other areas of specialty/work
Street address
Nutrition and Food Sciences Faculty, Razi Blvd
City
Shiraz
Postal code
7153675541
Phone
+98 717251008
Fax
Email
h_eftekhari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Sasan Amanat
Position
Msc student of Nutrition
Other areas of specialty/work
Street address
Nutrition and Food Sciences Faculty, Razi blvd
City
Shiraz
Postal code
7413179144
Phone
+98 717251008
Fax
Email
snatm69@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)