Effect of diet restricted in advanced glycation end products (low-AGEs) on vascular adhesion, inflammatory markers, vascular vasodilation (FMD), energy expenditure and brown adipose tissue activity in patients treated with angioplasty
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Protocol summary
Patients are randomly divided into two groups of 40: intervention and control. Food record questionnaire to measure and control macronutrients and AGEs intake in the diet and physical activity registration to measure energy expenditure and adjustment of physical activity effect on AGEs production in body will be evaluated in beginning and every two weeks during the study. Ten milliliter fasting blood will be taken from all patients at the beginning and end of the intervention.
Patients are randomly divided into two groups of 21: intervention and control. Food record questionnaire to measure and control macronutrients and AGEs intake in the diet and physical activity registration to measure energy expenditure and adjustment of physical activity effect on AGEs production in body will be evaluated in beginning and every two weeks during the study. Ten milliliter fasting blood will be taken from all patients at the beginning and end of the intervention.
Patients are randomly divided into two groups of 4021: intervention and control. Food record questionnaire to measure and control macronutrients and AGEs intake in the diet and physical activity registration to measure energy expenditure and adjustment of physical activity effect on AGEs production in body will be evaluated in beginning and every two weeks during the study. Ten milliliter fasting blood will be taken from all patients at the beginning and end of the intervention.
افراد بطور تصادفی به دو گروه 40 نفره مداخله و کنترل تقسیم می شوند. پرسشنامه ثبت خوراک به منظور کنترل و محاسبه میزان دریافت درشت مغذی ها و AGEs در رژیم غذایی و ثبت فعالیت بدنی به منظور محاسبه میزان مصرف انرژی و کنترل اثر فعالیت بدنی بر تولید AGEs در بدن در ابتدا و هر دو هفته یکبار در حین مطالعه ارزیابی خواهد شد. از همه افراد ناشتا 10 سی سی خون ابتدا و انتهای مداخله گرفته خواهد شد.
افراد بطور تصادفی به دو گروه 21 نفره مداخله و کنترل تقسیم می شوند. پرسشنامه ثبت خوراک به منظور کنترل و محاسبه میزان دریافت درشت مغذی ها و AGEs در رژیم غذایی و ثبت فعالیت بدنی به منظور محاسبه میزان مصرف انرژی و کنترل اثر فعالیت بدنی بر تولید AGEs در بدن در ابتدا و هر دو هفته یکبار در حین مطالعه ارزیابی خواهد شد. از همه افراد ناشتا 10 سی سی خون ابتدا و انتهای مداخله گرفته خواهد شد.
افراد بطور تصادفی به دو گروه 4021 نفره مداخله و کنترل تقسیم می شوند. پرسشنامه ثبت خوراک به منظور کنترل و محاسبه میزان دریافت درشت مغذی ها و AGEs در رژیم غذایی و ثبت فعالیت بدنی به منظور محاسبه میزان مصرف انرژی و کنترل اثر فعالیت بدنی بر تولید AGEs در بدن در ابتدا و هر دو هفته یکبار در حین مطالعه ارزیابی خواهد شد. از همه افراد ناشتا 10 سی سی خون ابتدا و انتهای مداخله گرفته خواهد شد.
General information
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42
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Due to the outbreak of COVID-19, the work process of the hospital was disrupted and sampling was stopped for several months, and now that the work process of the hospital has returned to the previous state, the admission rate of patients is much lower than before. On the other hand, a large number of patients are reluctant to participate in the study due to the need to go to the hospital after the intervention and the high risk of developing COVID-19 if they go to the hospital. In general, these problems have disrupted the sampling of the study.
Due to the outbreak of COVID-19, the work process of the hospital was disrupted and sampling was stopped for several months, and now that the work process of the hospital has returned to the previous state, the admission rate of patients is much lower than before. On the other hand, a large number of patients are reluctant to participate in the study due to the need to go to the hospital after the intervention and the high risk of developing COVID-19 if they go to the hospital. In general, these problems have disrupted the sampling of the study.
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به دلیل شیوع بیماری کوید-19 در روند کار بیمارستان اختلال ایجاد شد و به مدت چندین ماه نمونه گیری متوقف شد و در حال حاضر که روند کاری بیمارستان به حالت قبل برگشته، میزان پذیرش بیماران بسیار کمتر از قبل شده است. از طرف دیگر تعداد زیادی از بیماران به دلیل لزوم رجوع به بیمارستان پس از مداخله و بالا بودن احتمال ابتلا به کوید-19 در صورت مراجعه به بیمارستان، تمایل به همکاری در مطالعه ندارند. در مجموع این مشکلات باعث ایجاد اختلال در نمونه گیری طرح شده است.
به دلیل شیوع بیماری کوید-19 در روند کار بیمارستان اختلال ایجاد شد و به مدت چندین ماه نمونه گیری متوقف شد و در حال حاضر که روند کاری بیمارستان به حالت قبل برگشته، میزان پذیرش بیماران بسیار کمتر از قبل شده است. از طرف دیگر تعداد زیادی از بیماران به دلیل لزوم رجوع به بیمارستان پس از مداخله و بالا بودن احتمال ابتلا به کوید-19 در صورت مراجعه به بیمارستان، تمایل به همکاری در مطالعه ندارند. در مجموع این مشکلات باعث ایجاد اختلال در نمونه گیری طرح شده است.
Since two variables of gender and BMI affect the outcomes of the study, and the two groups must be similar in terms of these two variables, randomization is done using stratified randomization based on these two variables. Combining the two variables of gender and BMI causes six classes: a man with a BMI less than 25, a man with a BMI of 25 to 30, a man with a BMI higher than 30, a woman with a BMI less than 25, a woman with a BMI of 25 to 30, and a woman with a BMI higher than 30. Then for each of these categories, random binary blocks are determined using table of random numbers. Eligible individuals entered the study, are placed in their own class according to their gender and BMI and based on the randomized sequences defined for that class, are assigned to either of the two groups receiving low-AGEs diet or cardiovascular diet (on basis of AHA recommendations).
Given that the intervention of this study is diet and the person who enters the patients in the study and describes the type of diet for each patient, cannot be blind to the type of diet that each patient receives, allocation concealment does not apply in this study.
Since the variable of gender affect the outcomes of the study, and the two groups must be similar in terms of this variable, randomization is done using stratified randomization based on this variable. Therefore, we will have two categories: men and women. Then for each of these categories, random binary blocks are determined using table of random numbers. Eligible individuals entered the study, are placed in their own category according to their gender and based on the randomized sequences defined for that category, are assigned to either of the two groups receiving low-AGEs diet or cardiovascular diet (on basis of AHA recommendations).
Given that the intervention of this study is diet and the person who enters the patients in the study and describes the type of diet for each patient, cannot be blind to the type of diet that each patient receives, allocation concealment does not apply in this study.
Since two variablesthe variable of gender and BMI affect the outcomes of the study, and the two groups must be similar in terms of these two variablesthis variable, randomization is done using stratified randomization based on thesethis variable. Therefore, we will have two variables. Combining the two variables of gendercategories: men and BMI causes six classes: a man with a BMI less than 25, a man with a BMI of 25 to 30, a man with a BMI higher than 30, a woman with a BMI less than 25, a woman with a BMI of 25 to 30, and a woman with a BMI higher than 30women. Then for each of these categories, random binary blocks are determined using table of random numbers. Eligible individuals entered the study, are placed in their own classcategory according to their gender and BMI and based on the randomized sequences defined for that classcategory, are assigned to either of the two groups receiving low-AGEs diet or cardiovascular diet (on basis of AHA recommendations). Given that the intervention of this study is diet and the person who enters the patients in the study and describes the type of diet for each patient, cannot be blind to the type of diet that each patient receives, allocation concealment does not apply in this study.
از آن جایی که دو متغیر جنس و BMI بر پیامدهای مورد بررسی اثر می گذارند و باید دو گروه از لحاظ این دو متغیر مشابه هم باشند، تقسیم تصادفی با استفاده از روش Stratified Randomization بر اساس این دو متغیر انجام می گیرد. ترکیب دو متغیر جنس و BMI باعث ایجاد 6 طبقه می شود: مرد با BMI کمتر از 25، مرد با BMI 25 تا 30، مرد با BMI بالاتر از 30، زن با BMI کمتر از 25، زن با BMI 25 تا 30 و زن با BMI بالاتر از 30. سپس برای هر یک از این طبقه ها، بلوک های تصادفی دوتایی با استفاده از جدول اعداد تصادفی تعیین می شود. افراد واجد شرایط وارد شده به مطالعه، با توجه به جنس و BMI شان در طبقه مخصوص به خود قرار گرفته و بر اساس توالی تصادفی سازی تعیین شده برای آن طبقه، در يکي از دو گروه دريافت کننده رژیم غذایی کم AGEs یا رژیم قلبی عروقی (بر اساس توصیه های AHA) قرار داده خواهند شد.
با توجه به اینکه مداخله در این مطالعه، رژیم غذایی بوده و فردی که بیماران را وارد مطالعه کرده و نوع رژیم غذایی هر بیمار را برایش توضیح می دهد، نسبت به نوع رژیم غذایی که هر بیمار دریافت می کند blind نمی تواند باشد، پنهان سازی در این مطالعه مصداق ندارد.
از آن جایی که متغیر جنس بر پیامدهای مورد بررسی اثر می گذارد و باید دو گروه از لحاظ این متغیر مشابه هم باشند، تقسیم تصادفی با استفاده از روش Stratified Randomization بر اساس این متغیر انجام می گیرد. بنابراین دو طبقه خواهیم داشت: مرد و زن. سپس برای هر یک از این طبقه ها، بلوک های تصادفی دوتایی با استفاده از جدول اعداد تصادفی تعیین می شود. افراد واجد شرایط وارد شده به مطالعه، با توجه به جنس در طبقه مخصوص به خود قرار گرفته و بر اساس توالی تصادفی سازی تعیین شده برای آن طبقه، در يکي از دو گروه دريافت کننده رژیم غذایی کم AGEs یا رژیم قلبی عروقی (بر اساس توصیه های AHA) قرار داده خواهند شد.
با توجه به اینکه مداخله در این مطالعه، رژیم غذایی بوده و فردی که بیماران را وارد مطالعه کرده و نوع رژیم غذایی هر بیمار را برایش توضیح می دهد، نسبت به نوع رژیم غذایی که هر بیمار دریافت می کند blind نمی تواند باشد، پنهان سازی در این مطالعه مصداق ندارد.
از آن جایی که دو متغیر جنس و BMI بر پیامدهای مورد بررسی اثر می گذارندگذارد و باید دو گروه از لحاظ این دو متغیر مشابه هم باشند، تقسیم تصادفی با استفاده از روش Stratified Randomization بر اساس این دو متغیر انجام می گیرد. ترکیببنابراین دو متغیر جنس و BMI باعث ایجاد 6 طبقه می شودخواهیم داشت: مرد با BMI کمتر از 25، مرد با BMI 25 تا 30، مرد با BMI بالاتر از 30، زن با BMI کمتر از 25، زن با BMI 25 تا 30 و زن با BMI بالاتر از 30. سپس برای هر یک از این طبقه ها، بلوک های تصادفی دوتایی با استفاده از جدول اعداد تصادفی تعیین می شود. افراد واجد شرایط وارد شده به مطالعه، با توجه به جنس و BMI شان در طبقه مخصوص به خود قرار گرفته و بر اساس توالی تصادفی سازی تعیین شده برای آن طبقه، در يکي از دو گروه دريافت کننده رژیم غذایی کم AGEs یا رژیم قلبی عروقی (بر اساس توصیه های AHA) قرار داده خواهند شد. با توجه به اینکه مداخله در این مطالعه، رژیم غذایی بوده و فردی که بیماران را وارد مطالعه کرده و نوع رژیم غذایی هر بیمار را برایش توضیح می دهد، نسبت به نوع رژیم غذایی که هر بیمار دریافت می کند blind نمی تواند باشد، پنهان سازی در این مطالعه مصداق ندارد.
Name of recruitment center - English: ُShahid Rajaie cardiovascular, medical and research center
Name of recruitment center - Persian: ّمرکز آموزشی تحقیقاتی و درمانی قلب و عروق شهید رجایی
Full name of responsible person - English: Fatemeh Taheri
Full name of responsible person - Persian: فاطمه طاهری
Street address - English: Valiasr St., next to Mellat Park
Street address - Persian: خیابان ولیعصر، جنب پارک ملت
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1995614331
Phone: +98 21 23921
Fax:
Email: sara.tayyebi@gmail.com
Web page address: http://rhc.ac.ir/fa
Name of recruitment center - English: Tehran Heart Center
Name of recruitment center - Persian: مرکز قلب تهران
Full name of responsible person - English: Ali Vasheghani Farahani
Full name of responsible person - Persian: علی واشقانی فراهانی
Street address - English: North Kargar Ave.
Street address - Persian: خیابان کارگر شمالی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: -
Phone: +98 21 8802 9600
Fax: +98 21 8802 9731
Email: thc@tums.ac.ir
Web page address: http://thc.tums.ac.ir/en
Name of recruitment center - English: ُShahid Rajaie cardiovascular, medical and research centerTehran Heart Center Name of recruitment center - Persian: ّمرکز آموزشی تحقیقاتی و درمانی قلب و عروق شهید رجاییتهران Full name of responsible person - English: Fatemeh TaheriAli Vasheghani Farahani Full name of responsible person - Persian: فاطمه طاهریعلی واشقانی فراهانی Street address - English: Valiasr StNorth Kargar Ave., next to Mellat Park Street address - Persian: خیابان ولیعصر، جنب پارک ملتکارگر شمالی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1995614331- Phone: +98 21 239218802 9600 Fax: +98 21 8802 9731 Email: sara.tayyebithc@gmail.comtums.ac.ir Web page address: http://rhc.ac.irthc.tums.ac.ir/fa en
Sponsors / Funding sources
#1
70
100
70100
#2
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohsen Tafaghodi
Full name of responsible person - Persian: محسن تفقدی
Street address - English: Daneshgah St.
Street address - Persian: خیابان دانشگاه
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: -
Phone: +98 51 3841 2081
Fax:
Email: presidentoffice@mums.ac.ir
Web page address: https://mums.ac.ir/
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mohsen Tafaghodi Full name of responsible person - Persian: محسن تفقدی Street address - English: Daneshgah St. Street address - Persian: خیابان دانشگاه City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: - Phone: +98 51 3841 2081 Fax: Email: presidentoffice@mums.ac.ir Web page address: https://mums.ac.ir/
Yes
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1
30
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30
Public
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public
Domestic
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domestic
Academic
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academic
Mashhad University of Medical Sciences
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Mashhad University of Medical Sciences
دانشگاه علوم پزشکی مشهد
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دانشگاه علوم پزشکی مشهد
Protocol summary
Study aim
The aim of this study is to determine the effect of diet restricted in advanced glycation end products (low-AGEs) on vascular adhesion, inflammatory markers, vascular vasodilation (Flow Mediated Dilation), energy expenditure and brown adipose tissue activity in patients treated with angioplasty.
Design
The present study is a parallel randomized clinical trial with a control group.
Settings and conduct
Patients are randomly divided into two groups of 21: intervention and control. Food record questionnaire to measure and control macronutrients and AGEs intake in the diet and physical activity registration to measure energy expenditure and adjustment of physical activity effect on AGEs production in body will be evaluated in beginning and every two weeks during the study. Ten milliliter fasting blood will be taken from all patients at the beginning and end of the intervention.
Participants/Inclusion and exclusion criteria
Patients aged 50 to 70 years whose BMI is between 18.5 to 35 kg/m2 and are required to undergo angioplasty due to obstruction in one or two vessels, will be enrolled. Patients with a history of diabetes, chronic kidney and liver diseases, autoimmune diseases and cancer, consumed multivitamin-mineral supplements over the past 3 months, followed any weight loss or other special diets during last year, or smoke won't be entered in study.
Intervention groups
To the intervention group, the low-AGEs diet, and to the control group, the cardiovascular diet based on general recommendations provided by AHA with focusing on the reduction of saturated fats and salt will be given. Both groups will be required to follow their diet for 12 weeks.
Main outcome variables
The amount of energy expenditure and vascular vasodilatation (FMD) and serum levels of IL-6, TNF-α, VCAM, hs-CRP, MDA, NRG4, FGF21 and carboxy methyl lysine will be measured in both groups before and After the intervention.
General information
Reason for update
Due to the outbreak of COVID-19, the work process of the hospital was disrupted and sampling was stopped for several months, and now that the work process of the hospital has returned to the previous state, the admission rate of patients is much lower than before. On the other hand, a large number of patients are reluctant to participate in the study due to the need to go to the hospital after the intervention and the high risk of developing COVID-19 if they go to the hospital. In general, these problems have disrupted the sampling of the study.
Acronym
IRCT registration information
IRCT registration number:IRCT20131125015536N10
Registration date:2019-11-24, 1398/09/03
Registration timing:registered_while_recruiting
Last update:2020-08-31, 1399/06/10
Update count:2
Registration date
2019-11-24, 1398/09/03
Registrant information
Name
Mohammad Javad Hosseinzadeh
Name of organization / entity
School of Nutritional Sciences and Dietetics, TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 3059
Email address
mhosseinzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-06, 1398/08/15
Expected recruitment end date
2020-11-05, 1399/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of diet restricted in advanced glycation end products (low-AGEs) on vascular adhesion, inflammatory markers, vascular vasodilation (FMD), energy expenditure and brown adipose tissue activity in patients treated with angioplasty
Public title
Effect of diet restricted in advanced glycation end products (low-AGEs) in patients treated with angioplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 50 to 70 years
BMI of 18.5 to 35 Kg/m2
Diagnosis of need for angioplasty treatment due to obstruction in one or two vessels
Exclusion criteria:
History of diabetes, thyroid disorders, chronic kidney diseases, liver disease, autoimmune diseases, cancer
History of myocardial infarction and stroke in the past 3 months
Use of multi-vitamin, mineral, and antioxidant supplements over the past 3 months
Follow of any weight loss diet or other special diets over the past year
Familial hypercholesterolemia and hypertriglyceridemia
History of well-known food allergy
History of previous angioplasty
Smoking, use of hubble-bubble and other drugs
Ladies before menopause
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Since the variable of gender affect the outcomes of the study, and the two groups must be similar in terms of this variable, randomization is done using stratified randomization based on this variable. Therefore, we will have two categories: men and women. Then for each of these categories, random binary blocks are determined using table of random numbers. Eligible individuals entered the study, are placed in their own category according to their gender and based on the randomized sequences defined for that category, are assigned to either of the two groups receiving low-AGEs diet or cardiovascular diet (on basis of AHA recommendations).
Given that the intervention of this study is diet and the person who enters the patients in the study and describes the type of diet for each patient, cannot be blind to the type of diet that each patient receives, allocation concealment does not apply in this study.
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 on Research, Research and Technology department of Tehran University of Medical Sci
Street address
Floor 6, Central Organization of University, corner of Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
-
Approval date
2019-06-23, 1398/04/02
Ethics committee reference number
IR.TUMS.VCR.REC.1398.334
Health conditions studied
1
Description of health condition studied
Atherosclerotic heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Carboxy methyl lysine
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA method
2
Description
high sensitive C-Reactive Protein (hs-CRP)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA method
3
Description
Tumor necrosis factor alpha (TNF-α)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA method
4
Description
Interleukin 6 (IL-6)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA method
5
Description
Vascular cell adhesion molecule 1 (VCAM-1)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA method
6
Description
Flow Mediated Dilation (FMD)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Sonography
7
Description
Basal metabolism rate
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Bioelectrical Impedance Analysis (BIA)
8
Description
Neuregulin 4 (NRG4)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA method
9
Description
Fibroblast growth factor 21 (FGF-21)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA method
Secondary outcomes
1
Description
Appetite
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Visual analog scale
2
Description
Nesfatin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELSA method
3
Description
Weight
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Weigher
4
Description
Waist circumference
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Meter
5
Description
Body composition
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Bioelectrical Impedance Analysis (BIA)
6
Description
Serum lipid profile (total cholesterol, triglyceride, LDL and HDL)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Enzymatic method
7
Description
Fasting Blood Sugar
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Enzymatic method
8
Description
Hemoglobin A1C
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Ion exchange chromatography
9
Description
Serum fasting insulin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA method
10
Description
Omentin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA method
11
Description
Insulin resistance
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Calculation based on HOMA-IR formula
Intervention groups
1
Description
Intervention group: Individuals in the intervention group will receive isocaloric low AGEs diet (based on dietary recommendations by Uribarrie et al.) for 12 weeks. The general recommendations of American Heart Association for cardiovascular diseases focused on reduction of saturated fats to less than 6 percent of calories, reduction of salt intake to less than 2400 mg per day, and reduction of calorie intake from simple sugars to less than 150 kilocalories per day in men and less than 100 kilocalories per day in women will be considered in the design of this diet, so that the only difference in the diet of the intervention and control group would be the amount of AGEs intake. The list of foods that should be omitted from diet (foods with high amount of AGEs), alternative food sources, the proper type and time of food preparation method in order to reduce the amount of AGEs intake will be explained both verbally and in writing.
Category
Prevention
2
Description
Control group: To the individuals in the control group, isocaloric cardiovascular diet (based on general recommendations by American Heart Association) will be given for 12 weeks. This diet focused on the reduction of saturated fats to less than 6 percent of calories, reduction of salt intake to less than 2400 mg per day, and reduction of calorie intake from simple sugars to less than 150 kilocalories per day in men and less than 100 kilocalories per day in women.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Ali Vasheghani Farahani
Street address
North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8802 9600
Fax
+98 21 8802 9731
Email
thc@tums.ac.ir
Web page address
http://thc.tums.ac.ir/en
2
Recruitment center
Name of recruitment center
Shahid Rajaie Cardiovascular, Medical and Research Center
Full name of responsible person
Ata Firouzi
Street address
Next to Mellat Park, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
atafirouzi@yahoo.com
Web page address
http://rhc.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Research and Technology Department of University
Street address
Floor 6, Central Organization of University, corner of Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8163 3698
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Javad Hossein Zadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences and Dietetics, No. 44, Hodjat doost Alley, Naderi St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8895 5975
Email
mhosseinzadeh@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Javad Hossein Zadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences and Dietetics, No. 44, Hodjat doost Alley, Naderi St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8895 5975
Email
mhosseinzadeh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Taheri
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
School of Nutritional Sciences and Dietetics, No. 44, Hodjat doost Alley, Naderi St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
-
Phone
00
Email
f.taheri6474@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