Investigation of the Effect of Dietary Management Based on Iranian Traditional Medicine on Insulin Resistance in patients with Non- Alcoholic Fatty Liver Disease: A controlled clinical trial
This study is a controlled clinical trial and investigates the effect of dietary management based on Iranian Traditional Medicine on insulin resistance in patients with non- alcoholic atty liver disease compared with control group which receive modern diet. First, patients with NAFLD, according to the inclusion criteria approved by gastroentrologist are recruited. Then the patients are informed about the project and presence of case and control groups and after obtaining the consent; they can be enrolled into the project. 88 Patients will be divided in 2 groups randomly. The intervention and control groups fill the the forms and questionnaire. The intervention group receive Iranian Traditional Medicine dietary management and control group receive modern dietary recommendation. All patients will fill the food dairy questionnaire. The patients will be visited at months 0, 1, 2 and 3. In each visit the food dairy questionnaire, weight and waist circumferences will be checked. Each patient must perform 70% or more of commands. At the end of study, BMI, waist circumference, lab tests and liver sonography will be done and compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040927296N1
Registration date:2016-05-03, 1395/02/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-03, 1395/02/14
Registrant information
Name
Zahra Gorji
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
z.gorji@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-04-30, 1395/02/11
Expected recruitment end date
2017-04-30, 1396/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Effect of Dietary Management Based on Iranian Traditional Medicine on Insulin Resistance in patients with Non- Alcoholic Fatty Liver Disease: A controlled clinical trial
Public title
The Effect of Dietary Management Based on Iranian Traditional Medicine on patients with Non- Alcoholic Fatty Liver Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: patient between 18 and 60years old; non alcoholic fatty liver (based on positive sonography and rule out of alcohol use; viral hepatitis; hemochromatosis; Wilson disease and autoimmune disease); no cirrhosis; patient with insulin resistance.
Exclusion criteria: the reluctance of patients to continue to cooperate; insulin injection; food allergies; liver obstructive diseases and patient hospitalization.
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:
88
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
Medical Ethics Committee, Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St., Shahid Chamran Highway university of Medical Sciences.
City
Tehran
Postal code
Approval date
2016-03-06, 1394/12/16
Ethics committee reference number
IR.SBMU.REC.1394.161
Health conditions studied
1
Description of health condition studied
Fatty liver disease
ICD-10 code
k70-k77
ICD-10 code description
Diseases of liver
Primary outcomes
1
Description
Insulin resistance
Timepoint
Before intervention and 3 months after intervention
Method of measurement
HOMA-IR formula
Secondary outcomes
1
Description
Body Mass Index
Timepoint
Before intervention and months1,2 and after intervention
Method of measurement
Scale and Meter
2
Description
waist circumference
Timepoint
Before intervention and months1,2 and after intervention
Method of measurement
meter
3
Description
Alanine Aminotransferase
Timepoint
Before intervention and at the end of intervention
Method of measurement
Spectrophotometer
4
Description
Aaspartat Aminotransferase
Timepoint
Before intervention and at the end of intervention
Method of measurement
Spectrophotometer
5
Description
Fasting blood sugar
Timepoint
Before intervention and at the end of intervention
Method of measurement
Spectrophotometer
6
Description
quality of life
Timepoint
At the beginning of intervention and at the end of intervention
Method of measurement
Questionnaire (SF-36)
7
Description
HgbA1C
Timepoint
Before intervention and at the end of intervention
Method of measurement
TINIA
8
Description
Serum Insulin
Timepoint
At the beginning of intervention and at the end of intervention
Method of measurement
ECL
9
Description
Serum Albumin
Timepoint
At the beginning of intervention and at the end of intervention
Method of measurement
Spectrophotometer
10
Description
Ferritin
Timepoint
At the beginning of intervention and at the end of intervention
Method of measurement
ELISA
Intervention groups
1
Description
The case group will receive the dietary recommendations based on Iranian traditional medicine designed for fatty liver. This includes elimination of food items that are harmful to liver and addition of items that are beneficial for liver. Each patient will complete the food diary questionnaire everyday which will be evaluated every month.Those patients that have followed less than 70% of the recommendations will be excluded from study.
Category
Lifestyle
2
Description
The control group will receive modern nutrition dietary recommendations. Each patient will complete the food diary questionnaire everyday which will be evaluated every month.Those patients that have followed less than 70% of the recommendations will be excluded from the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gasterointestinal Diseases Clinic in Baqiyatallah Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Traditional Medicine,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mahmood Mosadegh
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran Tehran Tehran Iran, Islamic Republic Of
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Traditional Medicine,Shahid Beheshti 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
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Gorji
Position
Ph.D student of Traditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
z.gorji@sbmu.ac.ir z.gorji@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rasool Choopani
Position
Traditional Medicine Specialist, Assistant Professor
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
rchoopani@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Gorji
Position
Ph.D student of Traditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
z.gorji@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)