Comparison of the effect of high protein versus high carbohydrate intake at evening meal on glycemic control, lipid profile and oxidative stress in patients with type 2 diabetes
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Protocol summary
The aim of present study is to compare the effects of high protein versus high carbohydrate intake at evening meal on glycemic control, lipid profile and oxidative stress in patients with type 2 diabetes. This study is a randomized controlled trial (parallel design) with study duration of 10 weeks. One hundred and thirty five patients with type 2 diabetes mellitus who have hemoglobin A1c (HbA1c) less than or equal to 8% and do not take insulin or α glucosidase inhibitors will be recruited by convenience sampling. Then they will be randomly assigned into three groups of “standard evening meal”, “high protein evening meal” and “high carbohydrate evening meal” and receive their respective diets. In “standard evening meal” group; carbohydrate, protein and fat have a balanced distribution among meals while in “high carbohydrate evening meal” group 40-45% of daily carbohydrate intake and in “high protein evening meal” group, 40-45% of daily protein intake will be allocated to evening meal and bedtime snack. Participants with poor dietary adherence will be excluded from the study. Body weight and waist circumference will be measured before the intervention, at week 5 and at the end of the intervention. Furthermore fasting glucose, HbA1c, insulin, lipid profile and oxidative stress will be measured at the beginning and at the end of the intervention. Fasting glucose will be also measured at weeks 2 and 5.
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The aim of present study is to compare the effects of high protein versus high carbohydrate intake at evening meal on glycemic control, lipid profile and oxidative stress in patients with type 2 diabetes. This study is a randomized controlled trial (parallel design) with study duration of 10 weeks. One hundred and thirty five patients with type 2 diabetes mellitus who have hemoglobin A1c (HbA1c) less than or equal to 8% and do not take insulin or α glucosidase inhibitors will be recruited by convenience sampling. Then they will be randomly assigned into three groups of “standard evening meal”, “high protein evening meal” and “high carbohydrate evening meal” and receive their respective diets. In “standard evening meal” group; carbohydrate, protein and fat have a balanced distribution among meals while in “high carbohydrate evening meal” group 40-45% of daily carbohydrate intake and in “high protein evening meal” group, 40-45% of daily protein intake will be allocated to evening meal and bedtime snack. Participants with poor dietary adherence will be excluded from the study. Body weight and waist circumference will be measured before the intervention, at week 5 and at the end of the intervention. Furthermore fasting glucose, HbA1c, insulin, lipid profile and oxidative stress will be measured at the beginning and at the end of the intervention. Fasting glucose will be also measured at weeks 2 and 5.
هدف از انجام این مطالعه مقایسه اثر مصرف بالای پروتئین با کربوهیدرات در وعده شام بر کنترل گلیسمک، پروفایل لیپیدی و استرس اکسیداتیو در بیماران مبتلا به دیابت نوع 2 می باشد. این مطالعه یک کار¬آزمایی کنترل شده تصادفی از نوع موازی با طول مدت مداخله 10 هفته می باشد. 135 فرد مبتلا به دیابت نوع 2 که هموگلوبین ای وان سی (HbA1c) کم تر مساوی 8 درصد داشته و انسولین و داروهای مهار کننده آلفا گلوکوزیداز مصرف نمی کنند بر اساس نمونه گیری آسان انتخاب خواهند گردید. سپس افراد به صورت تصادفی به 3 گروه دریافت کننده وعده شام استاندارد، با پروتئین بالا و با کربوهیدرات بالا تقسیم بندی می شوند و به هر یک از آن ها یک رژیم غذایی داده خواهد شد. در رژیم گروه دریافت کننده شام استاندارد؛ کربوهیدرات، پروتئین و چربی به میزان متعادلی بین وعده های غذایی توزیع خواهند شد در صورتی که در رژیم گروه دریافت کننده شام با پروتئین بالا، %45-40 پروتئین دریافتی روزانه و در گروه دریافت کننده شام با کربوهیدرات بالا، %45-40 کربوهیدرات دریافتی روزانه در وعده شام و میان وعده آخر شب گنجانده خواهند شد. افرادی که پایبندی ضعیفی به رژیم غذایی مربوطه داشته باشند از مطالعه خارج خواهند گردید. وزن بدن و دور کمر، قبل از مداخله، هفته 5 و بعد از مداخله اندازه گیری می گردند. قند ناشتا، HbA1c، انسولین، پروفایل لیپیدی و استرس اکسیداتیو نیز در ابتدا و انتهای مداخله اندازه گیری می شوند. قند ناشتا در هفته 2 و 5 نیز اندازه گیری خواهد شد.
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هدف از انجام این مطالعه مقایسه اثر مصرف بالای پروتئین با کربوهیدرات در وعده شام بر کنترل گلیسمک، پروفایل لیپیدی و استرس اکسیداتیو در بیماران مبتلا به دیابت نوع 2 می باشد. این مطالعه یک کار¬آزمایی کنترل شده تصادفی از نوع موازی با طول مدت مداخله 10 هفته می باشد. 135 فرد مبتلا به دیابت نوع 2 که هموگلوبین ای وان سی (HbA1c) کم تر مساوی 8 درصد داشته و انسولین و داروهای مهار کننده آلفا گلوکوزیداز مصرف نمی کنند بر اساس نمونه گیری آسان انتخاب خواهند گردید. سپس افراد به صورت تصادفی به 3 گروه دریافت کننده وعده شام استاندارد، با پروتئین بالا و با کربوهیدرات بالا تقسیم بندی می شوند و به هر یک از آن ها یک رژیم غذایی داده خواهد شد. در رژیم گروه دریافت کننده شام استاندارد؛ کربوهیدرات، پروتئین و چربی به میزان متعادلی بین وعده های غذایی توزیع خواهند شد در صورتی که در رژیم گروه دریافت کننده شام با پروتئین بالا، %45-40 پروتئین دریافتی روزانه و در گروه دریافت کننده شام با کربوهیدرات بالا، %45-40 کربوهیدرات دریافتی روزانه در وعده شام و میان وعده آخر شب گنجانده خواهند شد. افرادی که پایبندی ضعیفی به رژیم غذایی مربوطه داشته باشند از مطالعه خارج خواهند گردید. وزن بدن و دور کمر، قبل از مداخله، هفته 5 و بعد از مداخله اندازه گیری می گردند. قند ناشتا، HbA1c، انسولین، پروفایل لیپیدی و استرس اکسیداتیو نیز در ابتدا و انتهای مداخله اندازه گیری می شوند. قند ناشتا در هفته 2 و 5 نیز اندازه گیری خواهد شد.
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The aim of present study is to compare the effects of high protein versus high carbohydrate intake at evening meal on glycemic control, lipid profile and oxidative stress in patients with type 2 diabetes.
The aim of present study is to compare the effects of high protein versus high carbohydrate intake at evening meal on glycemic control, lipid profile and oxidative stress in patients with type 2 diabetes.
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هدف از انجام این مطالعه مقایسه اثر مصرف بالای پروتئین با کربوهیدرات در وعده شام بر کنترل گلیسمک، پروفایل لیپیدی و استرس اکسیداتیو در بیماران مبتلا به دیابت نوع 2 می باشد.
هدف از انجام این مطالعه مقایسه اثر مصرف بالای پروتئین با کربوهیدرات در وعده شام بر کنترل گلیسمک، پروفایل لیپیدی و استرس اکسیداتیو در بیماران مبتلا به دیابت نوع 2 می باشد.
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This is a 10-week single blinded, randomized controlled trial. Applying block randomization, the participants will randomly assigned to either of the following three groups: Standard evening meal, High carbohydrate evening meal and High protein evening meal. Sample size was calculated to be 30 in each group.
This is a 10-week single blinded, randomized controlled trial. Applying block randomization, the participants will randomly assigned to either of the following three groups: Standard evening meal, High carbohydrate evening meal and High protein evening meal. Sample size was calculated to be 30 in each group.
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این مطالعه یک کار آزمایی کنترل شده تصادفی یک سو کور با طول مدت مداخله 10 هفته می باشد. شرکت کنندگان با استفاده از تصادفی سازی بلوکی به یکی از این سه گروه تقسیم بندی می شوند: گروه دریافت کننده وعده شام استاندارد، گروه دریافت کننده وعده شام با کربوهیدرات بالا و گروه دریافت کننده وعده شام با پروتئین بالا. حجم نمونه مورد نیاز جهت انجام این مطالعه 30 نفر در هر گروه محاسبه گردید.
این مطالعه یک کار آزمایی کنترل شده تصادفی یک سو کور با طول مدت مداخله 10 هفته می باشد. شرکت کنندگان با استفاده از تصادفی سازی بلوکی به یکی از این سه گروه تقسیم بندی می شوند: گروه دریافت کننده وعده شام استاندارد، گروه دریافت کننده وعده شام با کربوهیدرات بالا و گروه دریافت کننده وعده شام با پروتئین بالا. حجم نمونه مورد نیاز جهت انجام این مطالعه 30 نفر در هر گروه محاسبه گردید.
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The Participants will be followed for 10 weeks, during which they visit the specially designated clinic in Shiraz city at weeks 2, 5 and 10.Body weight and waist circumference will be measured before the intervention, at week 5 and at the end of the intervention. Furthermore fasting glucose, HbA1c, insulin, lipid profile and oxidative stress will be measured at the beginning and at the end of the intervention. Fasting glucose will be also measured at week 5. Participants will be unaware of random allocation into different groups.
The Participants will be followed for 10 weeks, during which they visit the specially designated clinic in Shiraz city at weeks 2, 5 and 10.Body weight and waist circumference will be measured before the intervention, at week 5 and at the end of the intervention. Furthermore fasting glucose, HbA1c, insulin, lipid profile and oxidative stress will be measured at the beginning and at the end of the intervention. Fasting glucose will be also measured at week 5. Participants will be unaware of random allocation into different groups.
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افراد مورد مطالعه به مدت 10 هفته مورد پیگیری قرار گرفته و طی هفته های 2، 5 و 10 بعد از شروع مطالعه به درمانگاه واقع در شهر شیراز مراجعه می نمایند. وزن بدن و دور کمر، قبل از مداخله، هفته 5 و بعد از مداخله اندازه گیری می گردند. قند ناشتا، HbA1c، انسولین، پروفایل لیپیدی و استرس اکسیداتیو نیز در ابتدا و انتهای مداخله اندازه گیری می شوند. قند ناشتا در هفته 5 نیز اندازه گیری خواهد شد. شرکت کنندگان از تخصیص تصادفی به گروه های مختلف آگاهی نخواهند داشت.
افراد مورد مطالعه به مدت 10 هفته مورد پیگیری قرار گرفته و طی هفته های 2، 5 و 10 بعد از شروع مطالعه به درمانگاه واقع در شهر شیراز مراجعه می نمایند. وزن بدن و دور کمر، قبل از مداخله، هفته 5 و بعد از مداخله اندازه گیری می گردند. قند ناشتا، HbA1c، انسولین، پروفایل لیپیدی و استرس اکسیداتیو نیز در ابتدا و انتهای مداخله اندازه گیری می شوند. قند ناشتا در هفته 5 نیز اندازه گیری خواهد شد. شرکت کنندگان از تخصیص تصادفی به گروه های مختلف آگاهی نخواهند داشت.
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Inclusion criteria are having type 2 diabetes; diabetes duration of 1-15 years; age of 30-65 years old; HbA1c ≤ 8%; BMI 22-35 Kg/m2; not taking insulin or α glucosidase inhibitors; weight maintenance during past 3 month; not having heart, liver, kidney, thyroid, gastrointestinal and respiratory disorders or malignancies; not consuming alcohol; not being on special diets like vegan; not being pregnant or lactating.
Inclusion criteria are having type 2 diabetes; diabetes duration of 1-15 years; age of 30-65 years old; HbA1c ≤ 8%; BMI 22-35 Kg/m2; not taking insulin or α glucosidase inhibitors; weight maintenance during past 3 month; not having heart, liver, kidney, thyroid, gastrointestinal and respiratory disorders or malignancies; not consuming alcohol; not being on special diets like vegan; not being pregnant or lactating.
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معیار های ورود شامل ابتلا به دیابت نوع 2، طول مدت ابتلا به دیابت بین 1 تا 15 سال، سن بین 30 تا 65 سال، سطح هموگلوبین گلیکوزیله کم تر مساوی 8 درصد، شاخص توده بدنی 22 تا 35 کیلوگرم بر متر مربع، عدم مصرف انسولین و داروهای مهار کننده آلفا گلوکوزیداز، ثبات وزن طی 3 ماه گذشته، عدم ابتلا به اختلالات قلبی، کبدی، کلیوی، تیروئید، گوارشی، تنفسی یا بدخیمی ها، عدم مصرف الکل، نداشتن رژیم های غذایی خاص مانند گیاهخواری، عدم بارداری یا شیردهی.
معیار های ورود شامل ابتلا به دیابت نوع 2، طول مدت ابتلا به دیابت بین 1 تا 15 سال، سن بین 30 تا 65 سال، سطح هموگلوبین گلیکوزیله کم تر مساوی 8 درصد، شاخص توده بدنی 22 تا 35 کیلوگرم بر متر مربع، عدم مصرف انسولین و داروهای مهار کننده آلفا گلوکوزیداز، ثبات وزن طی 3 ماه گذشته، عدم ابتلا به اختلالات قلبی، کبدی، کلیوی، تیروئید، گوارشی، تنفسی یا بدخیمی ها، عدم مصرف الکل، نداشتن رژیم های غذایی خاص مانند گیاهخواری، عدم بارداری یا شیردهی.
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In Standard evening group, protein and carbohydrate are rather evenly distributed among meals. In High carbohydrate evening meal group, 40-45% of total carbohydrate intake is provided at dinner and evening snack. In High protein evening meal group, 40-45% of total protein intake is at dinner and evening snack.
In Standard evening group, protein and carbohydrate are rather evenly distributed among meals. In High carbohydrate evening meal group, 40-45% of total carbohydrate intake is provided at dinner and evening snack. In High protein evening meal group, 40-45% of total protein intake is at dinner and evening snack.
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در گروه دارای وعده شام استاندارد کربوهیدرات و پروتئین تقریبا به طور مساوی بین وعده های غذایی تقسیم شده اند. در رژیم دارای وعده شام با کربوهیدرات بالا 45-40 درصد کربوهیدارت مصرفی روزانه در وعده شام و میان وعده آخر شب قرار دارد. در رژیم دارای وعده شام با پروتئین بالا 45-40 درصد پروتئین مصرفی روزانه در وعده شام و میان وعده آخر شب قرار دارد.
در گروه دارای وعده شام استاندارد کربوهیدرات و پروتئین تقریبا به طور مساوی بین وعده های غذایی تقسیم شده اند. در رژیم دارای وعده شام با کربوهیدرات بالا 45-40 درصد کربوهیدارت مصرفی روزانه در وعده شام و میان وعده آخر شب قرار دارد. در رژیم دارای وعده شام با پروتئین بالا 45-40 درصد پروتئین مصرفی روزانه در وعده شام و میان وعده آخر شب قرار دارد.
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Hemoglobin A1c
Hemoglobin A1c
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هموگلوبین گلیکوزیله
هموگلوبین گلیکوزیله
General information
1
1
1
1
1
1
135
90
13590
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96
96
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2017-07-01, 1396/04/10
2017-07-01 00:00:00
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2017-12-22, 1396/10/01
2017-12-22 00:00:00
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2018-03-17, 1396/12/26
2018-03-17 00:00:00
Having type 2 diabetes mellitus according to American Diabetes Association criteria
Diabetes duration of 1-15 years
Age range of 30-65 years old
Hemoglobin A1c (HbA1c) less than or equal to 8%
Body mass index (BMI) 22- 35 kilograms per square meter
Weight maintenance (± 3 kg) during past 3 month
Stable medications during at least past two month
Willingness to participate in study
Having type 2 diabetes mellitus according to American Diabetes Association criteria Diabetes duration of 1-15 years Age range of 30-65 years old Hemoglobin A1c (HbA1c) less than or equal to 8% Body mass index (BMI) 22- 35 kilograms per square meter Weight maintenance (± 3 kg) during past 3 month Stable medications during at least past two month Willingness to participate in study
ابتلا به دیابت نوع 2 تأیید شده توسط پزشک بر اساس معیار های انجمن دیابت آمریکا
طول مدت ابتلا به دیابت بین 1 تا 15 سال
دامنه سنی بین 30 تا 65 سال
سطح هموگلوبین ای وان سی (HbA1c) کم تر مساوی 8 درصد
شاخص توده بدنی 22 تا 35 کیلوگرم بر متر مربع
ثبات وزن (3 ± کیلوگرم) طی 3 ماه گذشته
عدم تغییر داروهای مصرفی حداقل طی 2 ماه گذشته
تمایل به شرکت در طرح
ابتلا به دیابت نوع 2 تأیید شده توسط پزشک بر اساس معیار های انجمن دیابت آمریکا طول مدت ابتلا به دیابت بین 1 تا 15 سال دامنه سنی بین 30 تا 65 سال سطح هموگلوبین ای وان سی (HbA1c) کم تر مساوی 8 درصد شاخص توده بدنی 22 تا 35 کیلوگرم بر متر مربع ثبات وزن (3 ± کیلوگرم) طی 3 ماه گذشته عدم تغییر داروهای مصرفی حداقل طی 2 ماه گذشته تمایل به شرکت در طرح
Not taking insulin or α glucosidase inhibitors
Not having heart, liver, kidney, thyroid, gastrointestinal and respiratory disorders or malignancies
Not consuming alcohol
Not being on special diets like gluten free or vegan
Not being pregnant or lactating
Not taking insulin or α glucosidase inhibitors Not having heart, liver, kidney, thyroid, gastrointestinal and respiratory disorders or malignancies Not consuming alcohol Not being on special diets like gluten free or vegan Not being pregnant or lactating
عدم مصرف انسولین و داروهای مهار کننده آلفا گلوکوزیداز
عدم ابتلا به اختلالات قلبی، کبدی، کلیوی، تیروئید، گوارشی، تنفسی یا بدخیمی ها
عدم مصرف الکل
نداشتن رژیم های غذایی خاص مانند رژیم عاری از گلوتن یا رژیم گیاهخواری
عدم بارداری یا شیردهی
عدم مصرف انسولین و داروهای مهار کننده آلفا گلوکوزیداز عدم ابتلا به اختلالات قلبی، کبدی، کلیوی، تیروئید، گوارشی، تنفسی یا بدخیمی ها عدم مصرف الکل نداشتن رژیم های غذایی خاص مانند رژیم عاری از گلوتن یا رژیم گیاهخواری عدم بارداری یا شیردهی
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Participants were randomly assigned into three groups using block randomization. Block size of 3 was used. To do this, first participant was assigned into the first group, second participant into the second group and third participant into the third group and the process was continued.
Participants were randomly assigned into three groups using block randomization. Block size of 3 was used. To do this, first participant was assigned into the first group, second participant into the second group and third participant into the third group and the process was continued.
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افراد توسط تصادفی سازی بلوکی به سه گروه تقسیم بندی گردیدند. برای این کار از بلوک های سه تایی استفاده گردید. بدین صورت که نفر اول وارد گروه اول، نفر دوم وارد گروه دوم و نفر سوم وارد گروه سوم می گردید و این روند ادامه پیدا می کرد.
افراد توسط تصادفی سازی بلوکی به سه گروه تقسیم بندی گردیدند. برای این کار از بلوک های سه تایی استفاده گردید. بدین صورت که نفر اول وارد گروه اول، نفر دوم وارد گروه دوم و نفر سوم وارد گروه سوم می گردید و این روند ادامه پیدا می کرد.
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Participants were not aware of random allocation to different groups. Statistics specialist is also unaware of intervention each group received.
Participants were not aware of random allocation to different groups. Statistics specialist is also unaware of intervention each group received.
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افراد شرکت کننده آگاهی نسبت به تخصیص تصادفی به گروه های متفاوت در این مطالعه نداشتند. فرد آنالیز کننده داده ها نیز از نوع درمان دریافتی افراد هر گروه بی اطلاع است.
افراد شرکت کننده آگاهی نسبت به تخصیص تصادفی به گروه های متفاوت در این مطالعه نداشتند. فرد آنالیز کننده داده ها نیز از نوع درمان دریافتی افراد هر گروه بی اطلاع است.
Recruitment centers
#1
Name of recruitment center - English: Shahid Motahari Clinic
Name of recruitment center - Persian: درمانگاه شهید مطهری
Full name of responsible person - English: Fatemeh Nouripour
Full name of responsible person - Persian: فاطمه نوری پور
Street address - English: Namazi Square
Street address - Persian: میدان نمازی
City - English: Shiraz
City - Persian: شیراز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Shahid Motahari Clinic
Name of recruitment center - Persian: درمانگاه شهید مطهری
Full name of responsible person - English: Fatemeh Nouripour
Full name of responsible person - Persian: فاطمه نوری پور
Street address - English: Namazi Square
Street address - Persian: میدان نمازی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7166776770
Phone: +98 71 3612 1000
Fax:
Email: nouripourf@sums.ac.ir
Web page address:
Name of recruitment center - English: Shahid Motahari Clinic Name of recruitment center - Persian: درمانگاه شهید مطهری Full name of responsible person - English: Fatemeh Nouripour Full name of responsible person - Persian: فاطمه نوری پور Street address - English: Namazi Square Street address - Persian: میدان نمازی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7166776770 Phone: +98 71 3612 1000 Fax: Email: nouripourf@sums.ac.ir Web page address:
#2
Name of recruitment center - English: Hakim Diabetes Clinic
Name of recruitment center - Persian: کلینیک دیابت درمانگاه حکیم
Full name of responsible person - English: Fatemeh Nouripour
Full name of responsible person - Persian: فاطمه نوری پور
Street address - English: Farhang Shahr
Street address - Persian: فرهنگ شهر
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 0000000000
Phone: +98 71 3632 5816
Fax:
Email: nouripourf@sums.ac.ir
Web page address:
Name of recruitment center - English: Hakim Diabetes Clinic Name of recruitment center - Persian: کلینیک دیابت درمانگاه حکیم Full name of responsible person - English: Fatemeh Nouripour Full name of responsible person - Persian: فاطمه نوری پور Street address - English: Farhang Shahr Street address - Persian: فرهنگ شهر City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 0000000000 Phone: +98 71 3632 5816 Fax: Email: nouripourf@sums.ac.ir Web page address:
#3
Name of recruitment center - English: AliAsghar Diabetes Clinic
Name of recruitment center - Persian: کلینیک دیابت بیمارستان علی اصغر
Full name of responsible person - English: Fatemeh Nouripour
Full name of responsible person - Persian: فاطمه نوری پور
Street address - English: Meshkinfam street
Street address - Persian: خیابان مشکین فام
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 0000000000
Phone: +98 71 3228 8602
Fax:
Email: nouripourf@sums.ac.ir
Web page address:
Name of recruitment center - English: AliAsghar Diabetes Clinic Name of recruitment center - Persian: کلینیک دیابت بیمارستان علی اصغر Full name of responsible person - English: Fatemeh Nouripour Full name of responsible person - Persian: فاطمه نوری پور Street address - English: Meshkinfam street Street address - Persian: خیابان مشکین فام City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 0000000000 Phone: +98 71 3228 8602 Fax: Email: nouripourf@sums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellery for research of Shiraz University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Kambiz Eskandari
Full name of responsible person - Persian: کامبیز اسکندری
Street address - English: Central building of Shiraz University of Medical Sciences, Zand st.
Street address - Persian: خیابان زند-روبروی خیابان فلسطین-ساختمان مرکزی دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Younes Ghasemi
Full name of responsible person - Persian: دكتر یونس قاسمی
Street address - English: Central building of Shiraz University of Medical Sciences, Zand st.
Street address - Persian: خیابان زند-روبروی خیابان فلسطین-ساختمان مرکزی دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134814336
Phone: +98 71 3235 7282
Fax:
Email: vcrdep@sums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellery for research of Shiraz University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شیراز Full name of responsible person - English: Kambiz EskandariDr.Younes Ghasemi Full name of responsible person - Persian: کامبیز اسکندریدكتر یونس قاسمی Street address - English: Central building of Shiraz University of Medical Sciences, Zand st. Street address - Persian: خیابان زند-روبروی خیابان فلسطین-ساختمان مرکزی دانشگاه علوم پزشکی شیراز City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7134814336 Phone: +98 71 3235 7282 Fax: Email: vcrdep@sums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Vice chancellery for research of Shiraz University of Medical Sciences
Shiraz University of Medical Sciences
Vice chancellery for research of Shiraz University of Medical Sciences
معاونت پژوهشی دانشگاه علوم پزشکی شیراز
دانشگاه علوم پزشکی شیراز
معاونت پژوهشی دانشگاه علوم پزشکی شیراز
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Shiraz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Fatemeh Nouripour
Full name of responsible person - Persian: فاطمه نوری پور
Position - English: Postgraduate student of nutrition sciences
Position - Persian: دانشجوی کارشناسی ارشد علوم تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of nutrition and food sciences, Razi Blvd.
Street address - Persian: بولوار رازی، دانشکده تغذیه و علوم غذایی
City - English: Siraz
City - Persian: شیراز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 71 3725 1007
Mobile: 00
Fax:
Email: nouripourf@sums.ac.ir; nouripour.fatemeh92@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fatemeh Nouripour
Full name of responsible person - Persian: فاطمه نوری پور
Position - English: Postgraduate student of nutrition sciences
Position - Persian: کارشناس ارشد علوم تغذیه
Latest degree: master
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of nutrition and food sciences, Razi Blvd.
Street address - Persian: بولوار رازی، دانشکده تغذیه و علوم غذایی
City - English: Siraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7153675541
Phone: +98 71 3725 1007
Mobile: +98 0000000000
Fax:
Email: nouripourf@sums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Shiraz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز Full name of responsible person - English: Fatemeh Nouripour Full name of responsible person - Persian: فاطمه نوری پور Position - English: Postgraduate student of nutrition sciences Position - Persian: دانشجوی کارشناسیکارشناس ارشد علوم تغذیه Latest degree: master Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of nutrition and food sciences, Razi Blvd. Street address - Persian: بولوار رازی، دانشکده تغذیه و علوم غذایی City - English: Siraz City - Persian: شیراز Province: Fars Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 7153675541 Phone: +98 71 3725 1007 Mobile: 00+98 0000000000 Fax: Email: nouripourf@sums.ac.ir; nouripour.fatemeh92@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Shiraz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Zohreh Mazloom
Full name of responsible person - Persian: زهره مظلوم
Position - English: Professor, Faculty member
Position - Persian: استاد و عضو هیئت علمی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of nutrition and food sciences, Razi Blvd.
Street address - Persian: بولوار رازی، دانشکده تغذیه و علوم غذایی
City - English: Shiraz
City - Persian: شیراز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 71 3725 1007
Mobile: 00
Fax:
Email: zmazloom@susms.ac.ir; zohreh.mazloom@gmai.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Zohreh Mazloom
Full name of responsible person - Persian: زهره مظلوم
Position - English: Professor, Faculty member
Position - Persian: استاد و عضو هیئت علمی
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of nutrition and food sciences, Razi Blvd.
Street address - Persian: بولوار رازی، دانشکده تغذیه و علوم غذایی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7153675541
Phone: +98 71 3725 1007
Mobile: +98 0000000000
Fax:
Email: zohreh.mazloom@gmai.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shiraz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز Full name of responsible person - English: Zohreh Mazloom Full name of responsible person - Persian: زهره مظلوم Position - English: Professor, Faculty member Position - Persian: استاد و عضو هیئت علمی Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of nutrition and food sciences, Razi Blvd. Street address - Persian: بولوار رازی، دانشکده تغذیه و علوم غذایی City - English: Shiraz City - Persian: شیراز Province: Fars Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 7153675541 Phone: +98 71 3725 1007 Mobile: 00+98 0000000000 Fax: Email: zmazloom@susms.ac.ir; zohreh.mazloom@gmai.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Shiraz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Fatemeh Nouripour
Full name of responsible person - Persian: فاطمه نوری پور
Position - English: Postgraduate student of nutrition sciences
Position - Persian: دانشجوی کارشناسی ارشد علوم تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of nutrition and food sciences, Razi Blvd.
Street address - Persian: بولوار رازی، دانشکده تغذیه و علوم غذایی
City - English: Shiraz
City - Persian: شیراز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 71 3725 1007
Mobile: 00
Fax:
Email: nouripourf@sums.ac.ir ;
nouripour.fatemeh92@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fatemeh Nouripour
Full name of responsible person - Persian: فاطمه نوری پور
Position - English: Postgraduate student of nutrition sciences
Position - Persian: کارشناس ارشد علوم تغذیه
Latest degree: master
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of nutrition and food sciences, Razi Blvd.
Street address - Persian: بولوار رازی، دانشکده تغذیه و علوم غذایی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7153675541
Phone: +98 71 3725 1007
Mobile: +98 0000000000
Fax:
Email: nouripourf@sums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Shiraz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز Full name of responsible person - English: Fatemeh Nouripour Full name of responsible person - Persian: فاطمه نوری پور Position - English: Postgraduate student of nutrition sciences Position - Persian: دانشجوی کارشناسیکارشناس ارشد علوم تغذیه Latest degree: master Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of nutrition and food sciences, Razi Blvd. Street address - Persian: بولوار رازی، دانشکده تغذیه و علوم غذایی City - English: Shiraz City - Persian: شیراز Province: Fars Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 7153675541 Phone: +98 71 3725 1007 Mobile: 00+98 0000000000 Fax: Email: nouripourf@sums.ac.ir ; nouripour.fatemeh92@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
na
na
undecided
undecided
undecided
undecided
na
na
na
na
empty
Undecided - It is not yet known if there will be a plan to make this available
Undecided - It is not yet known if there will be a plan to make this available
empty
En هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
En هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
Protocol summary
Study aim
The aim of present study is to compare the effects of high protein versus high carbohydrate intake at evening meal on glycemic control, lipid profile and oxidative stress in patients with type 2 diabetes.
Design
This is a 10-week single blinded, randomized controlled trial. Applying block randomization, the participants will randomly assigned to either of the following three groups: Standard evening meal, High carbohydrate evening meal and High protein evening meal. Sample size was calculated to be 30 in each group.
Settings and conduct
The Participants will be followed for 10 weeks, during which they visit the specially designated clinic in Shiraz city at weeks 2, 5 and 10.Body weight and waist circumference will be measured before the intervention, at week 5 and at the end of the intervention. Furthermore fasting glucose, HbA1c, insulin, lipid profile and oxidative stress will be measured at the beginning and at the end of the intervention. Fasting glucose will be also measured at week 5. Participants will be unaware of random allocation into different groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria are having type 2 diabetes; diabetes duration of 1-15 years; age of 30-65 years old; HbA1c ≤ 8%; BMI 22-35 Kg/m2; not taking insulin or α glucosidase inhibitors; weight maintenance during past 3 month; not having heart, liver, kidney, thyroid, gastrointestinal and respiratory disorders or malignancies; not consuming alcohol; not being on special diets like vegan; not being pregnant or lactating.
Intervention groups
In Standard evening group, protein and carbohydrate are rather evenly distributed among meals. In High carbohydrate evening meal group, 40-45% of total carbohydrate intake is provided at dinner and evening snack. In High protein evening meal group, 40-45% of total protein intake is at dinner and evening snack.
Main outcome variables
Hemoglobin A1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017042733666N1
Registration date:2017-06-30, 1396/04/09
Registration timing:prospective
Last update:2019-04-01, 1398/01/12
Update count:1
Registration date
2017-06-30, 1396/04/09
Registrant information
Name
Fatemeh Nouripour
Name of organization / entity
Shiraz Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1007
Email address
nouripourf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellery for research of Shiraz University of Medical Sciences
Expected recruitment start date
2017-07-01, 1396/04/10
Expected recruitment end date
2017-10-02, 1396/07/10
Actual recruitment start date
2017-07-01, 1396/04/10
Actual recruitment end date
2017-12-22, 1396/10/01
Trial completion date
2018-03-17, 1396/12/26
Scientific title
Comparison of the effect of high protein versus high carbohydrate intake at evening meal on glycemic control, lipid profile and oxidative stress in patients with type 2 diabetes
Public title
The effect of diet on diabetes management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes mellitus according to American Diabetes Association criteria
Diabetes duration of 1-15 years
Age range of 30-65 years old
Hemoglobin A1c (HbA1c) less than or equal to 8%
Body mass index (BMI) 22- 35 kilograms per square meter
Weight maintenance (± 3 kg) during past 3 month
Stable medications during at least past two month
Willingness to participate in study
Exclusion criteria:
Not taking insulin or α glucosidase inhibitors
Not having heart, liver, kidney, thyroid, gastrointestinal and respiratory disorders or malignancies
Not consuming alcohol
Not being on special diets like gluten free or vegan
Not being pregnant or lactating
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Actual sample size reached:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly assigned into three groups using block randomization. Block size of 3 was used. To do this, first participant was assigned into the first group, second participant into the second group and third participant into the third group and the process was continued.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were not aware of random allocation to different groups. Statistics specialist is also unaware of intervention each group received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2017-04-17, 1396/01/28
Ethics committee reference number
IR.SUMS.REC.1396.7
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Hemoglobin A1c
Timepoint
The begining and the end of the stuy
Method of measurement
In percent by using the assay kit
Secondary outcomes
1
Description
Serum malondialdehyde
Timepoint
The begining and the end of the study
Method of measurement
In micromolar by using the assay kit
2
Description
Anthropometric measurements (body weight and waist circumference)
Timepoint
The begining, middle and the end of the study
Method of measurement
By weighting scale with accuracy of 0.1 kg and measuring tape with accuracy of 0.1 cm
3
Description
Lipid profile (Triglyceride, Total cholestrol, Low density lipoprotein cholestrol, High density lipoprotein cholestrol)
Timepoint
The begining and the end of the study
Method of measurement
In milligram per deciliter by using the assay kit
4
Description
Fasting serum insulin
Timepoint
The begining and the end of the study
Method of measurement
In picomole per liter by using the assay kit
5
Description
Fasting serum glucose
Timepoint
The begining of the study, the end of weeks 2 and 5, the end of the study
Method of measurement
In milligram per deciliter by using the assay kit
Intervention groups
1
Description
Intervention group: A 10-week diet with 40-45% of daily carbohydrate intake at evening meal and bedtime snack
Category
Lifestyle
2
Description
Intervention group: A 10-week diet with 40-45% of daily protein intake at evening meal and bedtime snack
Category
Lifestyle
3
Description
Control group: A standard diet with balanced distribution of carbohydrate, protein and fat throughout the day
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Clinic
Full name of responsible person
Fatemeh Nouripour
Street address
Namazi Square
City
Shiraz
Province
Fars
Postal code
7166776770
Phone
+98 71 3612 1000
Email
nouripourf@sums.ac.ir
2
Recruitment center
Name of recruitment center
Hakim Diabetes Clinic
Full name of responsible person
Fatemeh Nouripour
Street address
Farhang Shahr
City
Shiraz
Province
Fars
Postal code
0000000000
Phone
+98 71 3632 5816
Email
nouripourf@sums.ac.ir
3
Recruitment center
Name of recruitment center
AliAsghar Diabetes Clinic
Full name of responsible person
Fatemeh Nouripour
Street address
Meshkinfam street
City
Shiraz
Province
Fars
Postal code
0000000000
Phone
+98 71 3228 8602
Email
nouripourf@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Younes Ghasemi
Street address
Central building of Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Nouripour
Position
Postgraduate student of nutrition sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of nutrition and food sciences, Razi Blvd.
City
Siraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1007
Fax
Email
nouripourf@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zohreh Mazloom
Position
Professor, Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of nutrition and food sciences, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1007
Fax
Email
zohreh.mazloom@gmai.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Nouripour
Position
Postgraduate student of nutrition sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of nutrition and food sciences, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1007
Fax
Email
nouripourf@sums.ac.ir
Web page address
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
Not applicable
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