The effect of dietary approaches to stop hypertension (DASH) diet on metabolic syndrome components and hepatic steatosis indices in subjects with metabolic syndrome
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General information
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60
60
No
No
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2022-10-22, 1401/07/30
2022-10-22 00:00:00
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2022-11-21, 1401/08/30
2022-11-21 00:00:00
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We added new secondary outcomes. In addition, we reported actual recruitment start and end dates.
We added new secondary outcomes. In addition, we reported actual recruitment start and end dates.
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ما پیامدهای ثانویه جدید اضافه کردیم. همچنین، تاریخ دقیق آغاز و پایان بیمارگیری را گزارش دادیم.
ما پیامدهای ثانویه جدید اضافه کردیم. همچنین، تاریخ دقیق آغاز و پایان بیمارگیری را گزارش دادیم.
Secondary outcomes
#1
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Fatty liver index
Fatty liver index
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شاخص کبد چرب
شاخص کبد چرب
empty
Before intervention and 12 weeks after the intervention
Before intervention and 12 weeks after the intervention
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قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته بعد از مداخله
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Formula
Formula
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فرمول
فرمول
#2
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Gamma-glutamyl transpeptidase
Gamma-glutamyl transpeptidase
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گاما گلوتامیل ترانس پپتیداز
گاما گلوتامیل ترانس پپتیداز
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
Enzymatic method
Enzymatic method
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روش آنزیمی
روش آنزیمی
#3
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Atherogenix index of plasma
Atherogenix index of plasma
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شاخص آتروژنیک پلاسما
شاخص آتروژنیک پلاسما
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
Formula
Formula
empty
فرمول
فرمول
#4
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Atherogenic coefficient
Atherogenic coefficient
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شاخص آتروژنیک
شاخص آتروژنیک
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
Formula
Formula
empty
فرمول
فرمول
#5
empty
Castelli risk index
Castelli risk index
empty
شاخص خطر کاستلی
شاخص خطر کاستلی
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
Formula
Formula
empty
فرمول
فرمول
#6
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Cardiometabolic index
Cardiometabolic index
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شاخص کاردیومتابولیک
شاخص کاردیومتابولیک
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
Formula
Formula
empty
فرمول
فرمول
#7
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TyG index
TyG index
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شاخص TyG
شاخص TyG
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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
Formula
Formula
empty
فرمول
فرمول
#8
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Metabolic score for insulin resistance
Metabolic score for insulin resistance
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امتیاز متابولیک برای مقاومت انسولینی
امتیاز متابولیک برای مقاومت انسولینی
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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
Formula
Formula
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فرمول
فرمول
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ali SHIRI
Full name of responsible person - Persian: علی شیری
Street address - English: Mollasadra Ave, Vanak Sq, Tehran
Street address - Persian: تهران ، میدان ونک ، خیابان ملاصدرا
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1435915371
Phone: +98 21 8248 3516
Fax:
Email: shira.reza@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ali Shiri
Full name of responsible person - Persian: علی شیری
Street address - English: Mollasadra Ave, Vanak Sq, Tehran
Street address - Persian: تهران ، میدان ونک ، خیابان ملاصدرا
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1435915371
Phone: +98 21 8248 3516
Fax:
Email: shira.reza@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ali SHIRIShiri Full name of responsible person - Persian: علی شیری Street address - English: Mollasadra Ave, Vanak Sq, Tehran Street address - Persian: تهران ، میدان ونک ، خیابان ملاصدرا City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1435915371 Phone: +98 21 8248 3516 Fax: Email: shira.reza@yahoo.com Web page address:
Protocol summary
Study aim
Evaluation of the effect of dietary approaches to stop hypertension (DASH) diet on metabolic syndrome components and hepatic steatosis indices in subjects with metabolic syndrome
Design
Randomized clinical trial
Settings and conduct
This 12-week study is a randomized controlled clinical trial that will investigate the effect of the DASH diet on the components of metabolic syndrome and indices of hepatic steatosis in subjects with metabolic syndrome with metabolic syndrome based on IDF criteria in Yazd city. Participation in the study is completely free and is managed by investigator who explainthe study process, goals, benefits and limitations and obtaining written consent with the participant's signature. Then, by examining other inclusion criteria for entering the study, the subjects are selected to start the intervention. Participants will be divided into intervention group or control group by a computer-generated random numbers table using a stratified randomization process based on gender and age.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 30-60 years old, Diagnosis of metabolic syndrome based on IDF criteria, Sign of informed written 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. Cushing syndrome 7.Kidney failure and kidney stones 8. Cardiovascular disease 9. History of hepatitis B and C 10. Wilson disease
Intervention groups
The intervention group will receive the DASH diet.
The control group will receive a standard diet.
Main outcome variables
Components of Metabolic syndrome including Waist circumference (WC); High density lipoprotein-cholesterol (HDL-c); Blood triglycerides (TG); Blood pressure; Fasting plasma glucose (FPG).
General information
Reason for update
We added new secondary outcomes. In addition, we reported actual recruitment start and end dates.
Acronym
IRCT registration information
IRCT registration number:IRCT20180201038585N12
Registration date:2022-10-21, 1401/07/29
Registration timing:prospective
Last update:2022-12-23, 1401/10/02
Update count:1
Registration date
2022-10-21, 1401/07/29
Registrant information
Name
Karim Parastouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 3516
Email address
parastouei@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-22, 1401/07/30
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
2022-10-22, 1401/07/30
Actual recruitment end date
2022-11-21, 1401/08/30
Trial completion date
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Scientific title
The effect of dietary approaches to stop hypertension (DASH) diet on metabolic syndrome components and hepatic steatosis indices in subjects with metabolic syndrome
Public title
The effect of DASH diet in subjects with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30-60 years
Diagnosis of Metabolic Syndrome based on IDF criteria
Sign of informed written consent
Exclusion criteria:
Pregnancy and lactation
Hereditary hemochromatosis
History of gingival or gastroplasty bypass surgery
Use of hepatotoxic drugs such as calcium channel blocker and high doses of synthetic estrogens
Patients with hypothyroidism
Cushing syndrome
Kidney failure and kidney stone
Cardiovascular disease
History of hepatitis B and C
Wilson disease
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be divided into intervention group or control group utilizing a random allocation software by a third trained person. A computer-generated random numbers table, presented by Saghaei in 2004, will be used to generate the random sequence. Baseline characteristics of the participants such as gender and age will be determined and recorded before random allocation. Then, using a stratified randomization process based on gender (male/female) and age (30–45 and 45–60 years) the participants will be divided into intervention group or control group. Allocation concealment will be conducted using opaque sealed envelopes to prevent selection bias by concealing the allocation sequence from those assigning participants to the intervention groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of baqiayatllah University of Medical Sciences
Street address
Moulla Sadra Ave , Vannak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2022-05-21, 1401/02/31
Ethics committee reference number
IR.BMSU.BAQ.REC.1401.016
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
Primary outcomes
1
Description
Diastolic Blood Pressure
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Sphygmomanometer
Secondary outcomes
1
Description
Waist Circumference
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Meter
2
Description
Triglyceride
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Enzymatic method
3
Description
High density lipoprotein cholesterol
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Enzymatic method
4
Description
Systolic blood pressure
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Sphygmomanometer
5
Description
Fasting blood glucose
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Enzymatic method
6
Description
Low density lipoprotein cholesterol
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Enzymatic method
7
Description
Total Cholesterol
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Enzymatic method
8
Description
Alanine Aminotransferase
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Enzymatic method
9
Description
Aspartat transaminase
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Enzymatic method
10
Description
Weight
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Scale
11
Description
Body mass index
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Formula
12
Description
Hepatic steatosis index
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Formula
13
Description
Lipid accumulation product
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Formula
14
Description
Visceral adiposity index
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Formula
15
Description
Fatty liver index
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Formula
16
Description
Gamma-glutamyl transpeptidase
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Enzymatic method
17
Description
Atherogenix index of plasma
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Formula
18
Description
Atherogenic coefficient
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Formula
19
Description
Castelli risk index
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Formula
20
Description
Cardiometabolic index
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Formula
21
Description
TyG index
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Formula
22
Description
Metabolic score for insulin resistance
Timepoint
Before intervention and 12 weeks after the intervention
Method of measurement
Formula
Intervention groups
1
Description
Intervention group: The intervention group will receive DASH (Dietary Approaches to Stop Hypertension) diet. This diet contains 52 to 55% carbohydrates, 16 to 18% protein and 30% fat. 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. 500 kcal for those with a BMI in the range of 25-31 kg/m2 and 700 kcal for those with a BMI more than 31 kg/m2 will be deducted from the total energy required by each person.
Category
Lifestyle
2
Description
Control group: The control group will receive a standard diet. 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. 500 kcal for those with a BMI in the range of 25-31 kg/m2 and 700 kcal for those with a BMI more than 31 kg/m2 will be deducted from the total energy required by each person.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Center
Full name of responsible person
Mahdieh Hosseinzadeh
Street address
Kashani Ave
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2232
Email
hoseinzade.mahdie@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ali Shiri
Street address
Mollasadra Ave, Vanak Sq, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8248 3516
Email
shira.reza@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mullasadra Ave, Vannak Sq,Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3264
Email
parastouei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mullasadra Ave, Vannak Sq, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3264
Email
parastouei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mullasadra Ave, Vannak Sq, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3264
Email
parastouei@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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