Protocol summary

Summary
Non-alcoholic fatty liver disease (NAFLD)is the most common liver disease. Diet plays an essential role in the management of disease. Recently, antioxidant-rich food sources such as soy products have gain a great interest in improvement of NAFLD. However, up to now, no study has investigated the effect of soy milk consumption on NAFLD. Therefore, the aim of this study is to assess the effects of soy milk consumption on metabolic and inflammatory status as well liver steatosis in NAFLD patients. In this randomized clinical trial study,70 patients aged 18 to 60 years will randomly assigned to intervention or control group. Since this study is a dietary intervention, there is no blinding. Both two group follow a 500-calorie deficit diet for 8 weeks. In intervention group, one glass of soy milk ( 240 cc ) is replaced with one serving of both starches and fats groups based on dietary exchange list. While, patients in the control group not allowed to consume any forms of soy products or isoflavone supplements during the study.All laboratory test including liver enzymes, lipid profile, markers of oxidative stress and inflammation, glycemic status, in addition hepatic steatosis, blood pressure and anthropometric indices will be measured at baseline and week 8 of the study. Also, the dietary intakes and physical activity will be measured at baseline and end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201701162709N40
Registration date: 2017-02-19, 1395/12/01
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-02-19, 1395/12/01
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Iran University of Medical Sciences.
Expected recruitment start date
2017-02-23, 1395/12/05
Expected recruitment end date
2018-02-24, 1396/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of soy milk consumption on liver enzymes,lipid profile,glycemic status, markers of inflammation and oxidative stress and hepatic steatosis in non-alcoholic fatty liver patients.
Public title
Effect of soy milk consumption on non-alcoholic fatty liver disease.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : patient aged 18- 60 y ; diagnosis of NAFLD in accordance to American Gastroenterological Association guidelines as follows: a) hepatic steatosis confirmed by ultrasonography , b) there are no cause for secondary steatosis such as alcohol consumption, hereditary disorders( e.g. hemochromatosis,wilson’s disease) ,autoimmune diseaseses ,hepatotoxic drugs (e.g. methotrexate , amiodaron, tamoxifen, corticosteroids, valproate and anti-viral drugs) and chronic hepatitis C ; Absence of any other co-disorders including but not limited to other chronic liver diseases (hepatitis), cirrhosis, celiac, diabetes, thyroid disorders, breast cysts, as well as cardiovascular, renal, respiratory ,inflammatory and autoimmune diseases ; Absence of cancer or a history of cancer in patient and his/her first-degree relatives ; BMI of 25 to 40 (kg/m2) ; having no allergy to soy milk ; consuming no nutritional supplements during the last two months ; Taking no anti-inflammatory drugs; hasn’t any history of drug abuse and smoking; no pregnancy or lactation ; willingness to participate and sign an informed written consent. Exclusion criteria: Lack of willingness to be a study participants during the study ; allergy or intolerance to soy milk during the study ; Lack of adherence to soy milk consumption ; existence of medical conditions that require special treatments during the study .
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: 70
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
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Postal code
1449614535
Approval date
2017-01-16, 1395/10/27
Ethics committee reference number
IR.IUMS.REC 1395.9411468003

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
Liver enzymes (ALT,AST,ALP,GGT)
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
colorimetery

2

Description
Lipid profile (TC,TG,HDL-C)
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
enzymatic method

3

Description
serum hs-CRP
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
immunoturbidimetry

4

Description
Insulin sensitivity index (QUICKI)
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
formula

5

Description
Fasting blood sugar
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
enzymatic method

6

Description
serum Insulin
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
Chemiluminescence immunoassay

7

Description
Malondialdehyde
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
colorimetery

8

Description
Insulin resistance (HOMA-IR)
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
formula

9

Description
the β-cell function ( % HOMA-β )
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
formula

10

Description
LDL-C
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
formula

11

Description
hepatic steatosis
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
ultrasonography

Secondary outcomes

1

Description
Systolic blood pressure
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
mercury sphygmomanometer

2

Description
Diastolic blood pressure
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
mercury sphygmomanometer

3

Description
Plasma fibrinogen
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
clauss method

4

Description
weight
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
Seca scale

5

Description
waist circumference
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
elastic tape

6

Description
Body mass index
Timepoint
before the experiment and 8 weeks after intervention
Method of measurement
formula

Intervention groups

1

Description
Control group ) following a 500- calorie deficit diet plan with macronutrients composition of 30 % fat , 15 % protein and 55 % carbohydrate
Category
Other

2

Description
Intervention group) The calorie and macronutrients composition of diet is equal to the control group.In this group, one glass of soy milk ( 240 cc ) is replaced with one serving of both starches and fats groups
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital, Iran University of Medical Sciences
Full name of responsible person
Dr.Shahram Agah
Street address
Rasoul Akram Hospital, Niyayesh St, Sattarkhan Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
7th Floor, , Department of Internal Medicine, Hazrat-E-Rasoul Hospital, Iran University of Medical Sciences, Niayesh St , Sattarkhan Ave, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr.Farzad Shidfar
Position
Professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8862 2755
Fax
Email
farzadshidfar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Farzad Shidfar
Position
Professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8862 2755
Fax
Email
farzadshidfar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Farzad Shidfar
Position
Professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8862 2755
Fax
Email
farzadshidfar@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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