The effect of DASH diet on hepatic fibrosis, hepatic steatosis, liver enzymes, insulin resistance and oxidative stress in patients with non-alcoholic fatty liver disease
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Protocol summary
Determining the effect of DASH diet on insulin resistance factors in patients with non-alcoholic fatty liver
Determining the effect of DASH diet on hepatic fibrosis, hepatic steatosis, liver enzymes, insulin resistance and oxidative stress in patients with non-alcoholic fatty liver
Determining the effect of DASH diet on hepatic fibrosis, hepatic steatosis, liver enzymes, insulin resistance factorsand oxidative stress in patients with non-alcoholic fatty liver
تعیین اثر رژیم غذایی DASH بر فاکتورهای مقاومت به انسولین در بیماران مبتلا به کبد چرب غیر الکلی
تعیین اثر رژیم غذایی DASH بر فیبروز کبدی، استئاتوز کبدی، آنزیم های کبدی، مقاومت انسولینی و استرس اکسیداتیو در بیماران مبتلا به کبد چرب غیر الکلی
تعیین اثر رژیم غذایی DASH بر فاکتورهایفیبروز کبدی، استئاتوز کبدی، آنزیم های کبدی، مقاومت به انسولینانسولینی و استرس اکسیداتیو در بیماران مبتلا به کبد چرب غیر الکلی
Double-blind randomized clinical trial
Randomized clinical trial
Double-blind randomizedRandomized clinical trial
کارآزمایی بالینی تصادفی سازی شده ی دو سوکور
کارآزمایی بالینی تصادفی سازی شده
کارآزمایی بالینی تصادفی سازی شده ی دو سوکور
گروه دریافت کننده ی رژیم DASH
گروه دریافت کننده رژیم DASH
گروه دریافت کننده ی رژیم DASH
FBS and insulin
Hepatic fibrosis, hepatic steatosis and liver enzymes
FBSHepatic fibrosis, hepatic steatosis and insulinliver enzymes
FBS و insulin
فیبروز کبدی، استئاتوز کبدی و آنزیم های کبدی
FBSفیبروز کبدی، استئاتوز کبدی و insulinآنزیم های کبدی
General information
Double blinded
Not blinded
doublnotbl
1
1
1
1
1
1
Other
Parallel
otherparal
Prevention
Treatment
prevntreat
N/A
3
na3
140
70
14070
empty
We revised title and sample size. In addition, we added outcomes.
We revised title and sample size. In addition, we added outcomes.
empty
ما عنوان و حجم نمونه را اصلاح کردیم. همچنین، ما پیامدها را اضافه کردیم.
ما عنوان و حجم نمونه را اصلاح کردیم. همچنین، ما پیامدها را اضافه کردیم.
The effect of DASH diet on insulin resistance indices(insulin, FBS), PAB, hcrp, SOD, TAC and catalase in patients with non-alcoholic fatty liver disease
Effect of DASH diet in patients with non-alcoholic fatty liver disease
The effectEffect of DASH diet on insulin resistance indices(insulin, FBS), PAB, hcrp, SOD, TAC and catalase in patients with non-alcoholic fatty liver disease
تاثیر رژیم غذایی DASH (رویکردهای رژیمی برای کنترل فشارخون) بر فاکتورهای مقاومت به انسولین(FBS و انسولین،شاخص هما و کوئیکی)،PAB و hcrp و کاتالاز،سوپراکسیددیسموتاز و TAC در بیمارات مبتلا به کبدچرب غیرالکلی
تاثیر رژیم غذایی DASH در بیماران مبتلا به کبدچرب غیرالکلی
تاثیر رژیم غذایی DASH (رویکردهای رژیمی برای کنترل فشارخون) بر فاکتورهای مقاومت به انسولین(FBS و انسولین،شاخص هما و کوئیکی)،PAB و hcrp و کاتالاز،سوپراکسیددیسموتاز و TAC در بیماراتبیماران مبتلا به کبدچرب غیرالکلی
The effect of DASH diet on insulin resistance indices(insulin, FBS), PAB, hcrp, SOD, TAC and catalase in patients with non-alcoholic fatty liver disease
The effect of DASH diet on hepatic fibrosis, hepatic steatosis, liver enzymes, insulin resistance and oxidative stress in patients with non-alcoholic fatty liver disease
The effect of DASH diet on hepatic fibrosis, hepatic steatosis, liver enzymes, insulin resistance indices(insulin, FBS), PAB, hcrp, SOD, TAC and catalaseoxidative stress in patients with non-alcoholic fatty liver disease
تاثیر رژیم غذایی DASH (رویکردهای رژیمی برای کنترل فشارخون) بر فاکتورهای مقاومت به انسولین(FBS و انسولین،شاخص هما و کوئیکی)،PAB و hcrp و کاتالاز،سوپراکسیددیسموتاز و TAC در بیمارات مبتلا به کبدچرب غیرالکلی
تاثیر رژیم غذایی DASH (رویکردهای رژیمی برای کنترل فشارخون) بر فیبروز کبدی، استئاتوز کبدی، آنزیم های کبدی و مقاومت انسولینی و استرس اکسیداتیو در بیماران مبتلا به کبدچرب غیرالکلی
تاثیر رژیم غذایی DASH (رویکردهای رژیمی برای کنترل فشارخون) بر فاکتورهایفیبروز کبدی، استئاتوز کبدی، آنزیم های کبدی و مقاومت به انسولین(FBSانسولینی و انسولین،شاخص هما و کوئیکی)،PAB و hcrp و کاتالاز،سوپراکسیددیسموتاز و TACاسترس اکسیداتیو در بیماراتبیماران مبتلا به کبدچرب غیرالکلی
It is not possible to blind the consultant, but the client is unaware of the type of diet. The statistical consultant is also unaware of the type of diet.
It is not possible to blind the consultant, but the client is unaware of the type of diet. The statistical consultant is also unaware of the type of diet.
امکان کورسازی برای مشاور وجود ندارد اما مراجعه کننده از نوع رژیم بی اطلاع است. مشاور آماری نیز از نوع رژیم بی اطلاع است.
امکان کورسازی برای مشاور وجود ندارد اما مراجعه کننده از نوع رژیم بی اطلاع است. مشاور آماری نیز از نوع رژیم بی اطلاع است.
Before intervention and 12 weeks after the intervention
Before intervention and 12 weeks after the intervention
empty
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
empty
Sphygmomanometer
Sphygmomanometer
empty
فشارسنج جیوه ای
فشارسنج جیوه ای
#4
empty
Fasting blood sugar
Fasting blood sugar
empty
قند خون ناشتا
قند خون ناشتا
empty
Before intervention and 12 weeks after the intervention
Before intervention and 12 weeks after the intervention
empty
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
empty
Special kit
Special kit
empty
کیت مخصوص
کیت مخصوص
#5
empty
Insulin
Insulin
empty
انسولین
انسولین
empty
Before intervention and 12 weeks after the intervention
Before intervention and 12 weeks after the intervention
empty
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
empty
Special kit
Special kit
empty
کیت مخصوص
کیت مخصوص
#6
empty
Total antioxidant capacity
Total antioxidant capacity
empty
ظرفیت تام آنتی اکسیدانی
ظرفیت تام آنتی اکسیدانی
empty
Before intervention and 12 weeks after intervention
Before intervention and 12 weeks after intervention
empty
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
empty
Special kit
Special kit
empty
کیت مخصوص
کیت مخصوص
#7
empty
Catalase
Catalase
empty
کاتالاز
کاتالاز
empty
Before intervention and 12 weeks after intervention
Before intervention and 12 weeks after intervention
empty
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
empty
Special kit
Special kit
empty
کیت مخصوص
کیت مخصوص
#8
empty
Superoxide dismutase
Superoxide dismutase
empty
سوپر اکسید دیسموتاز
سوپر اکسید دیسموتاز
empty
Before intervention and 12 weeks after intervention
Before intervention and 12 weeks after intervention
empty
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
empty
Special kit
Special kit
empty
کیت مخصوص
کیت مخصوص
#9
empty
PAB
PAB
empty
شاخص تعادل پروآنتی اکسیدان
شاخص تعادل پروآنتی اکسیدان
empty
Before intervention and 12 weeks after intervention
Before intervention and 12 weeks after intervention
empty
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
empty
Special kit
Special kit
empty
کیت مخصوص
کیت مخصوص
#10
empty
High sensitivity C-reactive protein
High sensitivity C-reactive protein
empty
پروتئین واکنشگر C با حساسیت بالا
پروتئین واکنشگر C با حساسیت بالا
empty
Before intervention and 12 weeks after intervention
Before intervention and 12 weeks after intervention
empty
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
empty
Special kit
Special kit
empty
کیت مخصوص
کیت مخصوص
#11
empty
Triglyceride
Triglyceride
empty
تری گلیسرید
تری گلیسرید
empty
Before intervention and 12 weeks after intervention
Before intervention and 12 weeks after intervention
empty
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
empty
Special kit
Special kit
empty
کیت مخصوص
کیت مخصوص
#12
empty
Total cholesterol
Total cholesterol
empty
کلسترول تام
کلسترول تام
empty
Before intervention and 12 weeks after intervention
Before intervention and 12 weeks after intervention
empty
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
empty
Special kit
Special kit
empty
کیت مخصوص
کیت مخصوص
#13
empty
High density lipoprotein cholesterol
High density lipoprotein cholesterol
empty
کلسترول لیپوپروتئین با چگالی بالا
کلسترول لیپوپروتئین با چگالی بالا
empty
Before intervention and 12 weeks after intervention
Before intervention and 12 weeks after intervention
empty
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
empty
Special kit
Special kit
empty
کیت مخصوص
کیت مخصوص
#14
empty
Low density lipoprotein cholesterol
Low density lipoprotein cholesterol
empty
کلسترول لیپوپروتئین با چگالی پایین
کلسترول لیپوپروتئین با چگالی پایین
empty
Before intervention and 12 weeks after intervention
Before intervention and 12 weeks after intervention
empty
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
empty
Special kit
Special kit
empty
کیت مخصوص
کیت مخصوص
#15
empty
Homeostatic model assessment of insulin resistance
Homeostatic model assessment of insulin resistance
empty
شاخص ارزیابی مقاومت انسولینی
شاخص ارزیابی مقاومت انسولینی
empty
Before intervention and 12 weeks after intervention
Before intervention and 12 weeks after intervention
empty
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
empty
Formula
Formula
empty
فرمول
فرمول
#16
empty
Insulin sensitivity check index
Insulin sensitivity check index
empty
شاخص ارزیابی حساسیت به انسولین
شاخص ارزیابی حساسیت به انسولین
empty
Before intervention and 12 weeks after intervention
Before intervention and 12 weeks after intervention
empty
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
empty
Formula
Formula
empty
فرمول
فرمول
Protocol summary
Study aim
Determining the effect of DASH diet on hepatic fibrosis, hepatic steatosis, liver enzymes, insulin resistance and oxidative stress in patients with non-alcoholic fatty liver
Design
Randomized clinical trial
Settings and conduct
The present study is a randomized controlled clinical trial to evaluate the effect of DASH counseling and diet on insulin resistance factors in patients with non-alcoholic fatty liver disease, which is referred to non-alcoholic fatty liver patients referred to the clinic Alikhani diabetes will be performed in Yazd for 12 weeks. In addition, people with diabetes receive their routine treatment under the supervision of a specialist. Smoking is a confounding factor and is eliminated in statistical models. Participation in the study is completely free and is managed by explaining in detail the study process, goals, benefits and limitations and obtaining written and oral consent with the patient's signature or, if necessary, by the patient's companion.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. People 18 to 70 years old 2. People with body mass index 25 to 40 3. Diagnosis based on liver fiberoscan 4. Have informed consent. Exclusion criteria: 1. Pregnancy and lactation 2. Hereditary hemochromatosis 3. History of gingival or gastroplasty bypass surgery 4. Use of hepatotoxic drugs such as calcium channel blocker and high doses of synthetic estrogens 5. Patients with hypothyroidism 6. Kushing syndrome 7.Kidney failure and kidney stones 8. Cardiovascular disease 9. People with a history of hepatitis B and C 10. Wilson disease
Intervention groups
DASH diet recipient group
Main outcome variables
Hepatic fibrosis, hepatic steatosis and liver enzymes
General information
Reason for update
We revised title and sample size. In addition, we added outcomes.
Acronym
IRCT registration information
IRCT registration number:IRCT20170117032026N3
Registration date:2022-02-06, 1400/11/17
Registration timing:registered_while_recruiting
Last update:2022-12-25, 1401/10/04
Update count:1
Registration date
2022-02-06, 1400/11/17
Registrant information
Name
Mahdie Hoseinzade
Name of organization / entity
Shahid Sadoughi University Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9110
Email address
hoseinzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of DASH diet on hepatic fibrosis, hepatic steatosis, liver enzymes, insulin resistance and oxidative stress in patients with non-alcoholic fatty liver disease
Public title
Effect of DASH diet in patients with non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: 1. People 18 to 70 years old 2. People with body mass index 25 to 40 3. Diagnosis based on liver fibroscan 4. Have informed consent.
Exclusion criteria:
1. Pregnancy and lactation 2. Hereditary hemochromatosis 3. History of gingival or gastroplasty bypass surgery 4. Use of hepatotoxic drugs such as calcium channel blockers and high doses of synthetic estrogens 5. Patients with hypothyroidism 6. Cushing's syndrome and 7. Kidney failure Kidney stones 8. Cardiovascular disease 9. People with a history of hepatitis B and C 10. Wilson disease
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The distribution of people between groups is done randomly and a random allocation table created using a computer is used.
Randomization is block type and classification based on gender and body mass index. In this study, individuals will be divided into two groups of intervention and control.
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 School of Public Health, Shahid Sadoughi University of Medical Sciences,
Street address
Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2021-10-30, 1400/08/08
Ethics committee reference number
IR.SSU.SPH.REC.1400.145
2
Ethics committee
Name of ethics committee
Ethics committee of School of Public Health, Shahid Sadoughi University of Medical Sciences,
Street address
Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2021-10-30, 1400/08/08
Ethics committee reference number
IR.SSU.SPH.REC.1400.144
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver disease
ICD-10 code
DB92.Y
ICD-10 code description
Non-alcoholic fatty liver disease
Primary outcomes
1
Description
Alanine Aminotransferase
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Special kits
2
Description
Aspartat transaminase
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Special kits
3
Description
Gamma-glutamyl transpeptidase
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Special kits
4
Description
Hepatic fibrosis
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Fibroscan
5
Description
Hepatic steatosis
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Fibroscan
Secondary outcomes
1
Description
Weight, fat mass, fat free mass, RMR, body mass index and visceral fat
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Omron digital Scale
2
Description
Waist,Hip circumference
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Meter
3
Description
Diastolic blood pressure
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Sphygmomanometer
4
Description
Systolic blood pressure
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Sphygmomanometer
5
Description
Fasting blood sugar
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Special kit
6
Description
Insulin
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Special kit
7
Description
Total antioxidant capacity
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Special kit
8
Description
Catalase
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Special kit
9
Description
Superoxide dismutase
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Special kit
10
Description
PAB
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Special kit
11
Description
High sensitivity C-reactive protein
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Special kit
12
Description
Triglyceride
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Special kit
13
Description
Total cholesterol
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Special kit
14
Description
High density lipoprotein cholesterol
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Special kit
15
Description
Low density lipoprotein cholesterol
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Special kit
16
Description
Homeostatic model assessment of insulin resistance
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Formula
17
Description
Insulin sensitivity check index
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Formula
Intervention groups
1
Description
DASH (Dietary Approaches to Stop Hypertension) diet. This diet contains 52 to 55% carbohydrates, 16 to 18% protein and 30% fat. The DASH diet is rich in fruits, vegetables, whole grains and low-fat dairy products, and is low in saturated fat, cholesterol and refined grains. Calories needed by each patient are estimated based on basal metabolic rate (using the Harris-Benedict equation) and levels of physical activity and energy from food metabolism. Everyone in the study is overweight or obese, and for these people the calorie limit of 500 to 700 kcal is less than the calculated energy requirement for each person. 500 kcal for those with a BMI in the range of 25-31 kg / m2 and 700 kcal for those with a BMI of more than 31 kg / m2 will be deducted from the total energy required by each person. An alternative list is provided to patients while educating the patient to facilitate food selection and to observe the principle of diversity between the components of each food group.
Category
N/A
2
Description
Standard diet
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Center (Ali Khani)
Full name of responsible person
Mohammad Reza Aghaei
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Email
drs@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Mahdie Hoseinzadeh
Street address
Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2232
Email
hoseinzade.mahdie@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Mahdie Hoseinzadeh
Position
Phd of nutritin
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2232
Email
hoseinzade.mahdie@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Mahdie Hoseinzadeh
Position
Phd of nutritin
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2232
Email
hoseinzade.mahdie@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Mahdie Hoseinzadeh
Position
PhD of nutrition science
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Public Health, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2232
Email
hoseinzade.mahdie@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available