The aim of this study is to investigate the effects of green tea consumption on blood iron indices and the healing process in patients with nonalcoholic fatty liver Disease (reduced insulin resistance and reduced levels of oxidative stress) and its effects on expression of genes associated with iron metabolism (Hemojuvelin). The study is a randomized double blind, placebo controlled clinical trial. Allocation is performed by block randomization method. Based on the allocation list, uniform drug packages are prepared and coded. Patients receive their drug package based on block randomization list. This package contains green tea or placebo tablets that look the same.
Main inclusion criteria: Known case of non alcoholic fatty liver Disease diagnosis of fatty liver by ultrasound, liver biopsy or liver FibroScan. Main exclusion criteria: green tea allergic reactions or other complications, taking less than 80% of the delivered dose of green tea, and being a pregnant or breast feeding.
The sample size is 50. The patients in the intervention group will receive green tea extract (ECGC 450 mg/d) for 3 months and those in the control group will receive placebo for the same duration. The main outcomes include measured changes in serum iron, insulin resistance, levels of oxidative stress, and changes in Hemojuvelin gene expression.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404132365N8
Registration date:2014-05-17, 1393/02/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-17, 1393/02/27
Registrant information
Name
Mohammad Reza Vafa
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4734
Email address
vafa.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Green Tea Consumption on Blood Iron indices, Oxidative Stress and Hemojuvelin Gene expression in NAFLD Patients
Public title
Effects of Green Tea Consumption on NAFLD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Known case of NAFLD, diagnosed by ultrasound of the liver, liver biopsy or liver Fibroscan; age 18 years or older; willingness to participate in research. Lack of inclusion criteria: iron deficiency anemia (hemoglobin less than 12 for women and 13 for men); allergy to green tea; alcohol consumption more than 20 g daily; viral hepatitis B and C; autoimmune hepatitis; celiac; wilson; alpha- antitrypsin deficiency. Exclusion criteria: symptoms of allergy or adverse effects of green tea consumption; taking less than 80% of the delivered dose of green tea; pregnancy or lactation; unwillingness to continue the study.
Age
From 18 years old to 65 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Express way
City
Tehran
Postal code
Approval date
2014-04-08, 1393/01/19
Ethics committee reference number
92-02-27-23599-100372
Health conditions studied
1
Description of health condition studied
Nonalcoholic fatty liver disease (NAFLD)
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) live, not elsewhere classified
Primary outcomes
1
Description
Hemojuvelin gene expression
Timepoint
Before and after intervention
Method of measurement
Polymerase chain reaction (PCR)
2
Description
Blood iron indices
Timepoint
Before and after intervention
Method of measurement
Laboratory
3
Description
Insulin resistance
Timepoint
Before and after intervention
Method of measurement
HOMA Index
4
Description
Total antioxidant capacity
Timepoint
Before and after intervention
Method of measurement
Laboratory
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
Before and after intervention
Method of measurement
Laboratory
2
Description
Liver enzymes
Timepoint
Before and after intervention
Method of measurement
Laboratory
3
Description
Serum insulin
Timepoint
Before and after intervention
Method of measurement
Laboratory
4
Description
Body mass index
Timepoint
Before and after intervention
Method of measurement
Body mass index
Intervention groups
1
Description
Intervention group: green tea catechins (ECGC) 450 mg/d for three months
Category
Treatment - Drugs
2
Description
Control group: placebo for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Hepatitis Center
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences, Deputy for Research
Full name of responsible person
Seyed Ali Javad Mousavi
Street address
Iran University of Medical Sciences, Hemmat Express way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences, Deputy for Research
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
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Express way
City
Tehran
Postal code
Phone
+98 21 8670 4734
Fax
Email
mrvafa@tums.ac.ir; vafa.m@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Express way
City
Tehran
Postal code
Phone
+98 21 8670 4734
Fax
Email
mrvafa@tums.ac.ir; vafa.m@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Express way
City
Tehran
Postal code
Phone
+98 21 8670 4734
Fax
Email
mrvafa@tums.ac.ir; vafa.m@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)