This study aimed to investigate the effect of turmeric on blood lipids (TG, HDL, LDL,VLDL, Total cholesterol ) malondialdehyde, liver enzymes( ALT, AST, GGT) and echogenicity of liver in patients with non-alcoholic fatty liver.
In this randomized double-blind clinical trial of 60 patients will be divided into 2 groups for 8 weeks of treatment with turmeric capsules (4 capsules daily) or placebo. Liver enzymes, malondialdehyde, lipid profile and the hepatic steatosis as well as anthropometric indices and physical activity at the beginning and end of the study will be determined. Statistical analysis will be done by SPSS version 17.If positive results available then turmeric could be used as source of hypolipidemic and antioxidant for the treatment of fatty liver.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092924262N1
Registration date:2015-10-25, 1394/08/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-25, 1394/08/03
Registrant information
Name
Maryam Jarahzadeh
Name of organization / entity
Ahvaz Jundishapur university medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 9737
Email address
jarahzadeh.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Paramedical Faculty, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Turmeric on lipid profile, malondialdehyde, liver echogenicity and enzymes in patients with non-alcoholic fatty liver
Public title
Turmeric effect on treatment non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosed fatty liver disease; absence of pregnancy and lactation; absence of diabetes, liver and biliary disorders, Celiac disease and cirrhosis, hepatitis B, C and autoimmune hepatitis. Lack of high blood pressure, cardiovascular disease, lung disease, kidney disease, cancer, thyroid, Wilson and hereditary hematochromatosis, no history of hospitalization or athlete, non-surgical weight loss in the last year, taking drugs like tamoxifen, lithium, phenytoin, antibiotics, metformin, Ursodeoxycholic acid (UDCA), no alcohol, no smoking, no history of hypothyroidism and Cushing's syndrome
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences ,Golestan Blvd.
City
Ahvaz
Postal code
1614896634
Approval date
2015-05-30, 1394/03/09
Ethics committee reference number
IR-AJUMS.REC.1394.104
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
Aspartate aminotransferase
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Concentration of AST with enzymatic method with kit
2
Description
Alanine aminotransferase
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Concentration of ALT in blood with enzymatic method with kit
3
Description
Gamma-glutamyl transpeptidase
Timepoint
Before intervention, 2 month later of intervention
Method of measurement
Concentration of GGT in blood with enzymatic method with kit
4
Description
Fasting blood sugar
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Concentration Fasting blood sugar with enzymatic method with kit
5
Description
Total cholestrol
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Concentration cholestrol of serum in fasting stage with enzymatic method with kit
6
Description
HDL-C
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Concentration of HDL-C serum in fasting stage with enzymatic method with kit
7
Description
LDL-C
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Concentration of LDL-C serum in fasting stage with fried method
8
Description
VLDL
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Concentration of VLDL serum in fasting stage with TG/5 Method
9
Description
Triglyciride
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Concentration of TG serum in fasting stage with enzymatic method with kit
10
Description
Hepatic steatosis
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Using ultrasound
11
Description
MDA
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Concentration of MDA serum in fasting stage with enzymatic method with kit
Secondary outcomes
1
Description
Weight
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Weight with Kilograms unit
2
Description
Body mass index
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Weight in Kilograms over Height in meters squared
3
Description
Total protein intake
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Dietary recall questionnaire
4
Description
Waist circumference
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Upper hip bone and place a measuring tape around the abdomen
5
Description
Hip circumference
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Hight waist circumference with measuring tape
6
Description
Blood pressure
Timepoint
Before intervention, 2 months after intervention
Method of measurement
(SBP-DBP)+ (DPB)/3
7
Description
AST/ALT Ratio
Timepoint
Before intervention, 2 months after intervention
Method of measurement
From divition of AST on ALT was made
8
Description
WHR
Timepoint
Before intervention, 2 months after intervention
Method of measurement
waist circumference to Hip circumference ratio
9
Description
Total energy intake
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Dietary recall questionnaire
10
Description
Total carbohydrate intake
Timepoint
Before intervention, 2 month later of intervention
Method of measurement
Dietary recall questionnaire
11
Description
Total fat intake
Timepoint
Before intervention, 2 months after intervention
Method of measurement
Dietary recall questionnaire
Intervention groups
1
Description
Cap containing placebo, 2 gr flour for daily usage for 2 month
Category
Placebo
2
Description
Turmeric with daily dose 2 gr for 2 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Education & Treatment Center of Emam Khomeini hospital
Full name of responsible person
Maryam Jarhzadeh
Street address
Emam Khomeini hospital, Azadegan alley
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutrition and Metabolic Disorders Research Center, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Ahvaz Jundishapur University of Medical Sciences , Golestan blvd.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutrition and Metabolic Disorders Research Center, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Maryam Jarahzadeh
Position
Student of master of science of nutrition science
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences , Golestan Aven.