Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Objectives : Determine the effects of prebiotic supplementation on women with type 2 diabetes. This Randomized, double-blind study to determine the effects of prebiotic supplementation on the level of perceived stress, cortisol, ghrelin, INFY levels and appetite among 80 women with type 2 diabetes will done. Patients were randomly divided to two groups. The randomization was performed based on block randomization procedure of size six. Afterwards to match the groups, each block involves the patients with the same categorizes of BMI and age. The allocation sequence was randomly generated by random allocation software (RAS). The intervention group will receive 10g/d resistant dextrin supplement and the control group will receive similar amounts of maltodextrin as placebo for 8 weeks. Supplements were divided in to two packages of 5 g each to be taken during breakfast and dinner with a cup of water.Inclusion criteria were: having type 2 diabetes for more than six months, using anti-diabetic drugs and maintaining them in the period of the study and having a normal diet and Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months. Type 2 diabetes was defined as a FPG level more than 126 mg/dl.
Patients were excluded if they had history of gastrointestinal; cardiovascular; renal; thyroid; liver; or pancreatic diseases; if they were pregnant; smokers; lactating; consuming pre/probiotics’ products; antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin; and finally if they had a typical fiber intake more than 30g/d.. Primary outcomes including perceived stress, cortisol, interfron gamma and secondary outcomes including ghrelin, and appetite.
empty
Objectives : Determine the effects of prebiotic supplementation on women with type 2 diabetes. This Randomized, double-blind study to determine the effects of prebiotic supplementation on the level of perceived stress, cortisol, ghrelin, INFY levels and appetite among 80 women with type 2 diabetes will done. Patients were randomly divided to two groups. The randomization was performed based on block randomization procedure of size six. Afterwards to match the groups, each block involves the patients with the same categorizes of BMI and age. The allocation sequence was randomly generated by random allocation software (RAS). The intervention group will receive 10g/d resistant dextrin supplement and the control group will receive similar amounts of maltodextrin as placebo for 8 weeks. Supplements were divided in to two packages of 5 g each to be taken during breakfast and dinner with a cup of water.Inclusion criteria were: having type 2 diabetes for more than six months, using anti-diabetic drugs and maintaining them in the period of the study and having a normal diet and Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months. Type 2 diabetes was defined as a FPG level more than 126 mg/dl. Patients were excluded if they had history of gastrointestinal; cardiovascular; renal; thyroid; liver; or pancreatic diseases; if they were pregnant; smokers; lactating; consuming pre/probiotics’ products; antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin; and finally if they had a typical fiber intake more than 30g/d.. Primary outcomes including perceived stress, cortisol, interfron gamma and secondary outcomes including ghrelin, and appetite.
هدف مطالعه: تعیین اثرات مکمل پری بیوتیک بر زنان مبتلا به دیابت نوع 2 بود. این مطالعه به صورت کارآزمایی بالینی دو سوکور با هدف تعیین تاثیر مکمل یاری پری بیوتیک بر سطح استرس ادراک شده، کورتیزول گرلین و INFY ، اشتها در بین 80 نفر از زنان مبتلا به دیابت نوع 2، انجام خواهد پذیرفت. بیماران بطور تصادفی به دو گروه 40 نفره مداخله (دریافت کننده دکسترین مقاوم) و کنترل(دریافت کننده مالتودکسترین) با استفاده از نرم افزار RAS و در قالب بلوک های 6 نفری بعد ازهماهنگ سازی از لحاظ سن و نمایه توده بدنی تقسیم خواهند شد. گروه مداخله روزانه 10 گرم دکسترین مقاوم و گروه کنترل 10گرم به مدت هشت هفته مالتودکسترین دریافت خواهند نمود. مکمل ها به صورت دو بسته پودر 5 گرمی در صبحانه و شام با یک لیوان آب دریافت خواهند شد. معیارهای ورود به مطالعه: شامل داشتن حداقل شش ماه سابقه ابتلا به دیابت، استفاده از داروهای پایین آورنده قند خون و حفظ آنها در طی مطالعه، داشتن یک رژیم نرمال و نمایه توده بدنی بیشتر از 25 در طی 3 ماه گذشته، افراد مبتلا به دیابت نوع 2 آنهایی هستند که قند خونشان بیشتر از 126 میلی گرم در دسی لیتر بود، معیارهای خروج از مطالعه: داشتن تاریخچه بیماریهای گوارشی، قلبی و عروقی، کلیوی، تیروئید، کبد یا پانکراس، حاملگی، سیگاری بودن، شیردهی، مصرف فرآورده های پری بیوتیک و پروبیوتیک، داروهای آنتی بیوتیک، آنتی اسید، الکل، ضد اسهال، ضد التهابی، کاهنده چربی خون، مسهل یا انسولین و مصرف فیبر به میزان بیشتر از 30 گرم در روز. پیامدهای اولیه شاما استرس ادراک شده، سزح کورتیزول و اینتروفرون گاما و پیامدهای ثانویه شامل گرلین و اشتها می باشد.
empty
هدف مطالعه: تعیین اثرات مکمل پری بیوتیک بر زنان مبتلا به دیابت نوع 2 بود. این مطالعه به صورت کارآزمایی بالینی دو سوکور با هدف تعیین تاثیر مکمل یاری پری بیوتیک بر سطح استرس ادراک شده، کورتیزول گرلین و INFY ، اشتها در بین 80 نفر از زنان مبتلا به دیابت نوع 2، انجام خواهد پذیرفت. بیماران بطور تصادفی به دو گروه 40 نفره مداخله (دریافت کننده دکسترین مقاوم) و کنترل(دریافت کننده مالتودکسترین) با استفاده از نرم افزار RAS و در قالب بلوک های 6 نفری بعد ازهماهنگ سازی از لحاظ سن و نمایه توده بدنی تقسیم خواهند شد. گروه مداخله روزانه 10 گرم دکسترین مقاوم و گروه کنترل 10گرم به مدت هشت هفته مالتودکسترین دریافت خواهند نمود. مکمل ها به صورت دو بسته پودر 5 گرمی در صبحانه و شام با یک لیوان آب دریافت خواهند شد. معیارهای ورود به مطالعه: شامل داشتن حداقل شش ماه سابقه ابتلا به دیابت، استفاده از داروهای پایین آورنده قند خون و حفظ آنها در طی مطالعه، داشتن یک رژیم نرمال و نمایه توده بدنی بیشتر از 25 در طی 3 ماه گذشته، افراد مبتلا به دیابت نوع 2 آنهایی هستند که قند خونشان بیشتر از 126 میلی گرم در دسی لیتر بود، معیارهای خروج از مطالعه: داشتن تاریخچه بیماریهای گوارشی، قلبی و عروقی، کلیوی، تیروئید، کبد یا پانکراس، حاملگی، سیگاری بودن، شیردهی، مصرف فرآورده های پری بیوتیک و پروبیوتیک، داروهای آنتی بیوتیک، آنتی اسید، الکل، ضد اسهال، ضد التهابی، کاهنده چربی خون، مسهل یا انسولین و مصرف فیبر به میزان بیشتر از 30 گرم در روز. پیامدهای اولیه شاما استرس ادراک شده، سزح کورتیزول و اینتروفرون گاما و پیامدهای ثانویه شامل گرلین و اشتها می باشد.
empty
Determine the effects of prebiotic supplementation on women with type 2 diabetes.
Determine the effects of prebiotic supplementation on women with type 2 diabetes.
empty
هدف مطالعه: تعیین اثرات مکمل پری بیوتیک دکسترین مقاوم بر زنان مبتلا به دیابت نوع 2 بود.
هدف مطالعه: تعیین اثرات مکمل پری بیوتیک دکسترین مقاوم بر زنان مبتلا به دیابت نوع 2 بود.
empty
This Randomized, double-blind study to determine the effects of prebiotic supplementation on women with type 2 diabetes will done. Patients were randomly divided to two groups based on block randomization procedure of size six by using random allocation software (RAS). Each block involves the patients with the same categorizes of BMI and age.
This Randomized, double-blind study to determine the effects of prebiotic supplementation on women with type 2 diabetes will done. Patients were randomly divided to two groups based on block randomization procedure of size six by using random allocation software (RAS). Each block involves the patients with the same categorizes of BMI and age.
empty
این مطالعه به صورت کارآزمایی بالینی دو سوکور با هدف تعیین تاثیر مکمل یاری پری بیوتیک بر روی زنان مبتلا به دیابت نوع 2، انجام خواهد پذیرفت. بیماران بطور تصادفی به دو گروه 40 نفره مداخله و کنترل با استفاده از نرم افزار RAS و در قالب بلوک های 6 نفری بعد از هماهنگ سازی از لحاظ سن و نمایه توده بدنی تقسیم خواهند شد.
این مطالعه به صورت کارآزمایی بالینی دو سوکور با هدف تعیین تاثیر مکمل یاری پری بیوتیک بر روی زنان مبتلا به دیابت نوع 2، انجام خواهد پذیرفت. بیماران بطور تصادفی به دو گروه 40 نفره مداخله و کنترل با استفاده از نرم افزار RAS و در قالب بلوک های 6 نفری بعد از هماهنگ سازی از لحاظ سن و نمایه توده بدنی تقسیم خواهند شد.
empty
This randomized, double-blind clinical trial will performed on T2DM from the Iran Diabetes Society
This randomized, double-blind clinical trial will performed on T2DM from the Iran Diabetes Society
empty
این کارآزمایی بالینی دو سوکور تصادفی، بر روی زنان دیابتی از انجمن دیابت ایران انجام خواهد گرفت.
این کارآزمایی بالینی دو سوکور تصادفی، بر روی زنان دیابتی از انجمن دیابت ایران انجام خواهد گرفت.
empty
Inclusion criteria were: having type 2 diabetes for more than six months, using anti-diabetic drugs and maintaining them in the period of the study and having a normal diet and Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months. Type 2 diabetes was defined as a FPG level more than 126 mg/dl. Patients were excluded if they had history of gastrointestinal; cardiovascular; renal; thyroid; liver; or pancreatic diseases; if they were pregnant; smokers; lactating; consuming pre/probiotics’ products; antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin; and finally if they had a typical fiber intake more than 30g/d
Inclusion criteria were: having type 2 diabetes for more than six months, using anti-diabetic drugs and maintaining them in the period of the study and having a normal diet and Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months. Type 2 diabetes was defined as a FPG level more than 126 mg/dl. Patients were excluded if they had history of gastrointestinal; cardiovascular; renal; thyroid; liver; or pancreatic diseases; if they were pregnant; smokers; lactating; consuming pre/probiotics’ products; antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin; and finally if they had a typical fiber intake more than 30g/d
empty
معیارهای ورود به مطالعه: شامل داشتن حداقل شش ماه سابقه ابتلا به دیابت، استفاده از داروهای پایین آورنده قند خون و حفظ آنها در طی مطالعه، داشتن یک رژیم نرمال و نمایه توده بدنی بیشتر از 25 در طی 3 ماه گذشته، افراد مبتلا به دیابت نوع 2 آنهایی هستند که قند خونشان بیشتر از 126 میلی گرم در دسی لیتر بود،معیارهای خروج از مطالعه: داشتن تاریخچه بیماریهای گوارشی، قلبی و عروقی، کلیوی، تیروئید، کبد یا پانکراس، حاملگی، سیگاری بودن، شیردهی، مصرف فرآورده های پری بیوتیک و پروبیوتیک، داروهای آنتی بیوتیک، آنتی اسید، الکل، ضد اسهال، ضد التهابی، کاهنده چربی خون، مسهل یا انسولین و مصرف فیبر به میزان بیشتر از 30 گرم در روز.
معیارهای ورود به مطالعه: شامل داشتن حداقل شش ماه سابقه ابتلا به دیابت، استفاده از داروهای پایین آورنده قند خون و حفظ آنها در طی مطالعه، داشتن یک رژیم نرمال و نمایه توده بدنی بیشتر از 25 در طی 3 ماه گذشته، افراد مبتلا به دیابت نوع 2 آنهایی هستند که قند خونشان بیشتر از 126 میلی گرم در دسی لیتر بود،معیارهای خروج از مطالعه: داشتن تاریخچه بیماریهای گوارشی، قلبی و عروقی، کلیوی، تیروئید، کبد یا پانکراس، حاملگی، سیگاری بودن، شیردهی، مصرف فرآورده های پری بیوتیک و پروبیوتیک، داروهای آنتی بیوتیک، آنتی اسید، الکل، ضد اسهال، ضد التهابی، کاهنده چربی خون، مسهل یا انسولین و مصرف فیبر به میزان بیشتر از 30 گرم در روز.
empty
The intervention group: 10g/d resistant dextrin supplement
The control group: 10g/d maltodextrin for 8 weeks.
The intervention group: 10g/d resistant dextrin supplement The control group: 10g/d maltodextrin for 8 weeks.
empty
گروه مداخله روزانه 10 گرم دکسترین مقاوم و گروه کنترل 10گرم به مدت هشت هفته مالتودکسترین دریافت خواهند نمود.
گروه مداخله روزانه 10 گرم دکسترین مقاوم و گروه کنترل 10گرم به مدت هشت هفته مالتودکسترین دریافت خواهند نمود.
Having type 2 diabetes for more than six months according International Diabetes Federation (fasting blood sugar level more than 126 mg/dl)
Using anti-diabetic drugs and maintaining them in the period of the study
Having a normal diet and Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months
Having type 2 diabetes for more than six months according International Diabetes Federation (fasting blood sugar level more than 126 mg/dl) Using anti-diabetic drugs and maintaining them in the period of the study Having a normal diet and Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months
داشتن حداقل شش ماه سابقه ابتلا به دیابت بر طبق فدراسیون بین المللی دیابت (قند خون ناشتا بیشتر از 126 میلی گرم در دسی لیتر)
استفاده از داروهای پایین آورنده قند خون و حفظ آنها در طی مطالعه
داشتن یک رژیم نرمال و نمایه توده بدنی بیشتر از 25 در طی 3 ماه گذشته
داشتن حداقل شش ماه سابقه ابتلا به دیابت بر طبق فدراسیون بین المللی دیابت (قند خون ناشتا بیشتر از 126 میلی گرم در دسی لیتر) استفاده از داروهای پایین آورنده قند خون و حفظ آنها در طی مطالعه داشتن یک رژیم نرمال و نمایه توده بدنی بیشتر از 25 در طی 3 ماه گذشته
Having history of gastrointestinal; cardiovascular; renal; thyroid; liver; or pancreatic diseases
Pregnancy and lactating
Smokers
Consuming prebiotic and probiotics’ products
Consuming antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin
Having a typical fiber intake more than 30g/d.
Having history of gastrointestinal; cardiovascular; renal; thyroid; liver; or pancreatic diseases Pregnancy and lactating Smokers Consuming prebiotic and probiotics’ products Consuming antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin Having a typical fiber intake more than 30g/d.
داشتن تاریخچه بیماریهای گوارشی، قلبی و عروقی، کلیوی، تیروئید، کبد یا پانکراس
حاملگی و شیردهی
سیگاری بودن
مصرف فرآورده های پری بیوتیک و پروبیوتیک
مصرف داروهای آنتی بیوتیک، آنتی اسید، الکل، ضد اسهال، ضد التهابی، کاهنده چربی خون، مسهل یا انسولین
مصرف فیبر به میزان بیشتر از 30 گرم در روز.
داشتن تاریخچه بیماریهای گوارشی، قلبی و عروقی، کلیوی، تیروئید، کبد یا پانکراس حاملگی و شیردهی سیگاری بودن مصرف فرآورده های پری بیوتیک و پروبیوتیک مصرف داروهای آنتی بیوتیک، آنتی اسید، الکل، ضد اسهال، ضد التهابی، کاهنده چربی خون، مسهل یا انسولین مصرف فیبر به میزان بیشتر از 30 گرم در روز.
Randomized block
Randomized block
بلوک بندی تصادفی
بلوک بندی تصادفی
empty
T2DM patients randomly allocated to two groups using a block randomization procedure, after matching of BMI and age.
T2DM patients randomly allocated to two groups using a block randomization procedure, after matching of BMI and age.
empty
بیماران دیابتی نوع 2 بعد از جورسازی براساس سن و نمایه توده بدنی با استفاده از نرم افزار RAS به طور تصادفی به دو گروه تخصیص داده خواهند شد.
بیماران دیابتی نوع 2 بعد از جورسازی براساس سن و نمایه توده بدنی با استفاده از نرم افزار RAS به طور تصادفی به دو گروه تخصیص داده خواهند شد.
empty
Researcher and patients will not be aware of the type of intervention. The third person will distribute the supplement among patients.
Researcher and patients will not be aware of the type of intervention. The third person will distribute the supplement among patients.
empty
محقق و بیماران از نوع مداخله آگاه نخواهند بود. نفر سوم مکمل را بین بیماران توزیع خواهد کرد.
محقق و بیماران از نوع مداخله آگاه نخواهند بود. نفر سوم مکمل را بین بیماران توزیع خواهد کرد.
Health conditions studied
#1
E10, E11
E08
E10, E11E08
Diabetes mellitus
Diabetes mellitus due to underlying condition
Diabetes mellitus due to underlying condition
Primary outcomes
#1
empty
IL18
IL18
empty
اینترلوکین 18
اینترلوکین 18
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
kit
kit
empty
کیت
کیت
#2
empty
Leptin
Leptin
empty
لپتین
لپتین
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
kit
kit
empty
کیت
کیت
#3
empty
adiponectin
adiponectin
empty
ادیپونکتین
ادیپونکتین
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
kit
kit
empty
کیت
کیت
#4
empty
IL10
IL10
empty
اینترلوکین 10
اینترلوکین 10
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
Kit
Kit
empty
کیت
کیت
#5
empty
insulin
insulin
empty
انسولین
انسولین
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
kit
kit
empty
کیت
کیت
#6
empty
TNF
TNF
empty
TNF
TNF
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
KIT
KIT
empty
کیت
کیت
#7
empty
IL6
IL6
empty
اینترلوکین 6
اینترلوکین 6
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
KIT
KIT
empty
کیت
کیت
#8
empty
FBS
FBS
empty
قندخون ناشتا
قندخون ناشتا
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
KIT
KIT
empty
کیت
کیت
Secondary outcomes
#1
Questionear
Questioner
QuestionearQuestioner
#2
empty
quality of life
quality of life
empty
کیفیت زندگی
کیفیت زندگی
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
Questioner
Questioner
empty
پرسشنامه
پرسشنامه
#3
empty
tryptophan
tryptophan
empty
تریپتوفان
تریپتوفان
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
kit
kit
empty
کیت
کیت
#4
empty
Kynurenine
Kynurenine
empty
کینورنین
کینورنین
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
kit
kit
empty
کیت
کیت
#5
empty
quality of life
quality of life
empty
کیفیت خواب
کیفیت خواب
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
questioner
questioner
empty
پرسشنامه
پرسشنامه
#6
empty
ALP
ALP
empty
آلکالین فسفاتاز
آلکالین فسفاتاز
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
kit
kit
empty
کیت
کیت
#7
empty
ALP
ALP
empty
الانین امینو ترانسفراز
الانین امینو ترانسفراز
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
KIT
KIT
empty
کیت
کیت
#8
empty
AST
AST
empty
اسپارتات امینو ترانسفراز
اسپارتات امینو ترانسفراز
empty
Before start intervention and 8 weeks after intervention
Before start intervention and 8 weeks after intervention
empty
قبل از مداخله و 8 هفته بعد از مداخله
قبل از مداخله و 8 هفته بعد از مداخله
empty
KIT
KIT
empty
کیت
کیت
Recruitment centers
#1
Name of recruitment center - English: Sina Hospital
Name of recruitment center - Persian: بیمارستان سینا
Full name of responsible person - English: Dehghan
Full name of responsible person - Persian: دهقان
Street address - English:
Street address - Persian:
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Sina Hospital
Name of recruitment center - Persian: بیمارستان سینا
Full name of responsible person - English: Dehghan
Full name of responsible person - Persian: دهقان
Street address - English: Atar
Street address - Persian: عطار
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3334 0634
Fax:
Email: dehghan.nut@gmail.com
Web page address:
Name of recruitment center - English: Sina Hospital Name of recruitment center - Persian: بیمارستان سینا Full name of responsible person - English: Dehghan Full name of responsible person - Persian: دهقان Street address - English: Atar Street address - Persian: عطار City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: +98 41 3334 0634 Fax: Email: dehghan.nut@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for reserach, Tabriz University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی، دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Parvin Dehghan
Full name of responsible person - Persian: پروین دهقان
Street address - English: Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
Street address - Persian: خ گلگشت، خ عطار نیشابوری، دانشکده تغذیه، دانشگاه علوم پزشکی تبریز.
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor for reserach, Tabriz University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی، دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Parvin Dehghan
Full name of responsible person - Persian: پروین دهقان
Street address - English: Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
Street address - Persian: خ گلگشت، خ عطار نیشابوری، دانشکده تغذیه، دانشگاه علوم پزشکی تبریز.
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 21 3334 0634
Fax:
Email: Dehghan.nut@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for reserach, Tabriz University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی، دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Parvin Dehghan Full name of responsible person - Persian: پروین دهقان Street address - English: Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street. Street address - Persian: خ گلگشت، خ عطار نیشابوری، دانشکده تغذیه، دانشگاه علوم پزشکی تبریز. City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: +98 21 3334 0634 Fax: Email: Dehghan.nut@gmail.com Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Tabriz university of medical sience
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dehghan
Full name of responsible person - Persian: دهقان
Position - English: PhD
Position - Persian: دکترای تخصصی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
Street address - Persian: خ گلگشت، خ عطار نیشابوری، دانشکده تغذیه، دانشگاه علوم پزشکی تبریز.
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3335 7581
Mobile: 00
Fax:
Email: DEHGHAN.NUT@GMAIL.COM
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz university of medical sience
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dehghan
Full name of responsible person - Persian: دهقان
Position - English: PhD
Position - Persian: دکترای تخصصی
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
Street address - Persian: خ گلگشت، خ عطار نیشابوری، دانشکده تغذیه، دانشگاه علوم پزشکی تبریز.
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3335 7581
Mobile: +98 914 471 0299
Fax:
Email: DEHGHAN.NUT@GMAIL.COM
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz university of medical sience Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Dehghan Full name of responsible person - Persian: دهقان Position - English: PhD Position - Persian: دکترای تخصصی Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street. Street address - Persian: خ گلگشت، خ عطار نیشابوری، دانشکده تغذیه، دانشگاه علوم پزشکی تبریز. City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: +98 41 3335 7581 Mobile: 00+98 914 471 0299 Fax: Email: DEHGHAN.NUT@GMAIL.COM Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Tabriz University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Parvin Dehghan
Full name of responsible person - Persian: پروین دهقان
Position - English: PhD
Position - Persian: دکترا
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
Street address - Persian: خ گلگشت، خ عطار نیشابوری، دانشکده تغذیه، دانشگاه علوم پزشکی تبریز.
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3335 7581
Mobile: 00
Fax:
Email: dehghan.nut@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Parvin Dehghan
Full name of responsible person - Persian: پروین دهقان
Position - English: PhD
Position - Persian: دکترا
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
Street address - Persian: خ گلگشت، خ عطار نیشابوری، دانشکده تغذیه، دانشگاه علوم پزشکی تبریز.
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3335 7581
Mobile: +98 914 471 0299
Fax:
Email: dehghan.nut@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz University Of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Parvin Dehghan Full name of responsible person - Persian: پروین دهقان Position - English: PhD Position - Persian: دکترا Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street. Street address - Persian: خ گلگشت، خ عطار نیشابوری، دانشکده تغذیه، دانشگاه علوم پزشکی تبریز. City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: +98 41 3335 7581 Mobile: 00+98 914 471 0299 Fax: Email: dehghan.nut@gmail.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Parvin dehghan
Full name of responsible person - Persian: پروین دهقان
Position - English:
Position - Persian:
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English:
Street address - Persian:
City - English:
City - Persian:
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: 00
Mobile: 00
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Parvin dehghan
Full name of responsible person - Persian: پروین دهقان
Position - English: استادیار
Position - Persian: Associate professor
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Atar
Street address - Persian: عطار
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3334 0634
Mobile: +98 914 471 0299
Fax:
Email: dehghan.nut@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Parvin dehghan Full name of responsible person - Persian: پروین دهقان Position - English: استادیار Position - Persian: Associate professor Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Atar Street address - Persian: عطار City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: 00+98 41 3334 0634 Mobile: 00+98 914 471 0299 Fax: Email: dehghan.nut@gmail.com Web page address:
Sharing plan
yes
yes
yes
yes
yes
yes
no
no
yes
yes
na
na
na
na
empty
Data on the baseline characteristics of subjects will be provided in the article.
Data on the baseline characteristics of subjects will be provided in the article.
empty
داده ای مربوط به مشخصات فردی در مقاله ارایه خواهد شد
داده ای مربوط به مشخصات فردی در مقاله ارایه خواهد شد
empty
2019
2019
empty
2019
2019
empty
Tabriz University of Medical Sciences
Tabriz University of Medical Sciences
empty
دانشگاه علوم پزشکی تبریز
دانشگاه علوم پزشکی تبریز
empty
The application must be submitted to Tabriz University of Medical Sciences. It will available, if Tabriz University of Medical Sciences is allowed.
The application must be submitted to Tabriz University of Medical Sciences. It will available, if Tabriz University of Medical Sciences is allowed.
empty
تقاضا باید تسلیم دانشگاه علوم پزشکی تبریز گردد. در صورت اجازه دانشگاه ، ان دردسترس خواهد بود.
تقاضا باید تسلیم دانشگاه علوم پزشکی تبریز گردد. در صورت اجازه دانشگاه ، ان دردسترس خواهد بود.
empty
Tabriz University of Medical Sciences
Tabriz University of Medical Sciences
empty
دانشگاه علوم پزشکی تبریز
دانشگاه علوم پزشکی تبریز
empty
The application must be submitted to Tabriz University of Medical Sciences. It will available, if Tabriz University of Medical Sciences is allowed.
The application must be submitted to Tabriz University of Medical Sciences. It will available, if Tabriz University of Medical Sciences is allowed.
empty
تقاضا باید تسلیم دانشگاه علوم پزشکی تبریز گردد. در صورت اجازه دانشگاه ، ان دردسترس خواهد بود.
تقاضا باید تسلیم دانشگاه علوم پزشکی تبریز گردد. در صورت اجازه دانشگاه ، ان دردسترس خواهد بود.
Protocol summary
Study aim
Determine the effects of prebiotic supplementation on women with type 2 diabetes.
Design
This Randomized, double-blind study to determine the effects of prebiotic supplementation on women with type 2 diabetes will done. Patients were randomly divided to two groups based on block randomization procedure of size six by using random allocation software (RAS). Each block involves the patients with the same categorizes of BMI and age.
Settings and conduct
This randomized, double-blind clinical trial will performed on T2DM from the Iran Diabetes Society
Participants/Inclusion and exclusion criteria
Inclusion criteria were: having type 2 diabetes for more than six months, using anti-diabetic drugs and maintaining them in the period of the study and having a normal diet and Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months. Type 2 diabetes was defined as a FPG level more than 126 mg/dl. Patients were excluded if they had history of gastrointestinal; cardiovascular; renal; thyroid; liver; or pancreatic diseases; if they were pregnant; smokers; lactating; consuming pre/probiotics’ products; antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin; and finally if they had a typical fiber intake more than 30g/d
Intervention groups
The intervention group: 10g/d resistant dextrin supplement
The control group: 10g/d maltodextrin for 8 weeks.
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2018-03-12, 1396/12/21
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of prebiotics effect on the level of perceived stress, cortisol, interferon gamma, and appetite in patients with type 2 diabetes.
Public title
Prebiotic effect in patients with type 2 diabetes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes for more than six months according International Diabetes Federation (fasting blood sugar level more than 126 mg/dl)
Using anti-diabetic drugs and maintaining them in the period of the study
Having a normal diet and Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months
Exclusion criteria:
Having history of gastrointestinal; cardiovascular; renal; thyroid; liver; or pancreatic diseases
Pregnancy and lactating
Smokers
Consuming prebiotic and probiotics’ products
Consuming antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin
Having a typical fiber intake more than 30g/d.
Age
From 30 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
T2DM patients randomly allocated to two groups using a block randomization procedure, after matching of BMI and age.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Researcher and patients will not be aware of the type of intervention. The third person will distribute the supplement among patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.TBZMED.REC.1395.949
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Cortisol
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Kit
2
Description
Interfron gamma
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Kit
3
Description
Perceived stress
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Perceived stress questionnaire
4
Description
IL18
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit
5
Description
Leptin
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit
6
Description
adiponectin
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit
7
Description
IL10
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Kit
8
Description
insulin
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit
9
Description
TNF
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
KIT
10
Description
IL6
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
KIT
11
Description
FBS
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
KIT
Secondary outcomes
1
Description
Appetite
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Questioner
2
Description
GHRELIN
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kite
3
Description
quality of life
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Questioner
4
Description
tryptophan
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit
5
Description
Kynurenine
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit
6
Description
quality of life
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
questioner
7
Description
ALP
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit
8
Description
ALP
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
KIT
9
Description
AST
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
KIT
Intervention groups
1
Description
Intervention group 1 : prebiotic (Nutriose,10g/d, for 8 weeks)
Category
Treatment - Other
2
Description
Intervention group 2 (placebo): Matodextrin (matodextrin ,10g/d, for 8 weeks)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dehghan
Street address
Atar
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0634
Email
dehghan.nut@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for reserach, Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 21 3334 0634
Email
Dehghan.nut@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for reserach, Tabriz 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
Tabriz university of medical sience
Full name of responsible person
Dehghan
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
Email
DEHGHAN.NUT@GMAIL.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
Email
dehghan.nut@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin dehghan
Position
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Atar
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0634
Fax
Email
dehghan.nut@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data on the baseline characteristics of subjects will be provided in the article.
When the data will become available and for how long
2019
To whom data/document is available
Tabriz University of Medical Sciences
Under which criteria data/document could be used
The application must be submitted to Tabriz University of Medical Sciences. It will available, if Tabriz University of Medical Sciences is allowed.
From where data/document is obtainable
Tabriz University of Medical Sciences
What processes are involved for a request to access data/document
The application must be submitted to Tabriz University of Medical Sciences. It will available, if Tabriz University of Medical Sciences is allowed.