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Protocol summary
Objective: The aim of this study is to determine the effects of Synbiotic supplementation on metabolic profiles in patients with gestational diabetes. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with gestational diabetes and aged 18 to 40 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 70 patients with gestational diabetes of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either Synbiotic supplements (n=35) and placebo (n=35). Synbiotic supplements and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and end of the intervention: 6 weeks. Outcomes: Metabolic profiles will be quantified at study baseline and end-of-trial.
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Objective: The aim of this study is to determine the effects of Synbiotic supplementation on metabolic profiles in patients with gestational diabetes. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with gestational diabetes and aged 18 to 40 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 70 patients with gestational diabetes of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either Synbiotic supplements (n=35) and placebo (n=35). Synbiotic supplements and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and end of the intervention: 6 weeks. Outcomes: Metabolic profiles will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری سین بیوتیک بر پروفایل های متابولیک در بیماران مبتلا به دیابت بارداری است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 70 بیمار مبتلا به دیابت بارداری واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل سین بیوتیک (35=n) و پلاسبو (35=n) تقسیم خواهند شد. کپسول های مکمل سین بیوتیک و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 6 هفته. پيامدها: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری سین بیوتیک بر پروفایل های متابولیک در بیماران مبتلا به دیابت بارداری است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 70 بیمار مبتلا به دیابت بارداری واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل سین بیوتیک (35=n) و پلاسبو (35=n) تقسیم خواهند شد. کپسول های مکمل سین بیوتیک و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 6 هفته. پيامدها: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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Objective: The aim of this study is to determine the effects of synbiotic supplementation on metabolic profiles in patients with gestational diabetes.
Objective: The aim of this study is to determine the effects of synbiotic supplementation on metabolic profiles in patients with gestational diabetes.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری سین بیوتیک بر پروفایل های متابولیک در بیماران مبتلا به دیابت بارداری است.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری سین بیوتیک بر پروفایل های متابولیک در بیماران مبتلا به دیابت بارداری است.
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Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive synbiotic supplements (n=35) or placebo (n=35).
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive synbiotic supplements (n=35) or placebo (n=35).
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طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور. بیماران برای دریافت مکمل سین بیوتیک (35=n) و پلاسبو (35=n) تقسیم خواهند شد.
طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور. بیماران برای دریافت مکمل سین بیوتیک (35=n) و پلاسبو (35=n) تقسیم خواهند شد.
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Among patients with gestational diabetes referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 70 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Among patients with gestational diabetes referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 70 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، 70 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، 70 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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Inclusion criteria: Patients with gestational diabetes, aged 18 to 40 years.
Exclusion criteria: Taking synbiotic or probiotic including probiotic yogurt, kefir and other fermented foods, taking insulin, placenta abruption, pre-eclampsia, eclampsia, hypo and hyperthyroidism, smokers, kidney or liver diseases.
Inclusion criteria: Patients with gestational diabetes, aged 18 to 40 years. Exclusion criteria: Taking synbiotic or probiotic including probiotic yogurt, kefir and other fermented foods, taking insulin, placenta abruption, pre-eclampsia, eclampsia, hypo and hyperthyroidism, smokers, kidney or liver diseases.
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معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری، در محدوده سنی 18 تا 40 سال.
معیار خروج از مطالعه: گرفتن سین بیوتیک یا پروبیوتیک از قبیل ماست پروبیوتیک، کفیر و سایر غذاهای تخمیر شده، گرفتن انسولین، جدا شدن زودرس جفت، پری اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید، سیگاری ها، بیماری های کلیوی و کبدی.
معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری، در محدوده سنی 18 تا 40 سال. معیار خروج از مطالعه: گرفتن سین بیوتیک یا پروبیوتیک از قبیل ماست پروبیوتیک، کفیر و سایر غذاهای تخمیر شده، گرفتن انسولین، جدا شدن زودرس جفت، پری اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید، سیگاری ها، بیماری های کلیوی و کبدی.
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Intervention group: Synbiotic capsule daily (Tak Gen Zist, Tehran, Iran) for 6 weeks orally. Control group: Placebo capsule (Tak Gen Zist, Tehran, Iran), for 6 weeks orally.
Intervention group: Synbiotic capsule daily (Tak Gen Zist, Tehran, Iran) for 6 weeks orally. Control group: Placebo capsule (Tak Gen Zist, Tehran, Iran), for 6 weeks orally.
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گروه مداخله: کپسول سین بیوتیک روزانه (تک ژن زیست، تهران، ایران)، به صورت خوراکی برای 6 هفته. گروه کنترل: کپسول پلاسبو (تک ژن زیست، تهران، ایران)، به صورت خوراکی برای 6 هفته.
گروه مداخله: کپسول سین بیوتیک روزانه (تک ژن زیست، تهران، ایران)، به صورت خوراکی برای 6 هفته. گروه کنترل: کپسول پلاسبو (تک ژن زیست، تهران، ایران)، به صورت خوراکی برای 6 هفته.
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Outcomes: Insulin Metabolism (primary outcomes) and lipid profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
Outcomes: Insulin Metabolism (primary outcomes) and lipid profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
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پيامدها: متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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Patients with gestational diabetes
Aged 18 to 40 years
Patients with gestational diabetes Aged 18 to 40 years
بیماران مبتلا به دیابت بارداری
در محدوده سنی 18 تا 40 سال
بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال
Taking synbiotic or probiotic including probiotic yogurt, kefir and other fermented foods
Taking insulin
Placenta abruption
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Smokers
Kidney or liver diseases
Taking synbiotic or probiotic including probiotic yogurt, kefir and other fermented foods Taking insulin Placenta abruption Pre-eclampsia Eclampsia Hypo and hyperthyroidism Smokers Kidney or liver diseases
گرفتن سین بیوتیک یا پروبیوتیک از قبیل ماست پروبیوتیک، کفیر و سایر غذاهای تخمیر شده
گرفتن انسولین
جدا شدن زودرس جفت
پری اکلامپسی
اکلامپسی
کم کاری و پرکاری تیروئید
سیگاری ها
بیماری های کلیوی و کبدی
گرفتن سین بیوتیک یا پروبیوتیک از قبیل ماست پروبیوتیک، کفیر و سایر غذاهای تخمیر شده گرفتن انسولین جدا شدن زودرس جفت پری اکلامپسی اکلامپسی کم کاری و پرکاری تیروئید سیگاری ها بیماری های کلیوی و کبدی
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To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
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برای کاهش اثرات مخدوش کنندگی بالقوه، همه شرکت کنندگان بر اساس نمایه توده بدنی (<25 و ≥25 کیلوگرم بر متر مربع) و سن (<30 و ≥30) تصادفی سازی لایه ای خواهند شد. سپس، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل یاری یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری انجام خواهد شد.
برای کاهش اثرات مخدوش کنندگی بالقوه، همه شرکت کنندگان بر اساس نمایه توده بدنی (<25 و ≥25 کیلوگرم بر متر مربع) و سن (<30 و ≥30) تصادفی سازی لایه ای خواهند شد. سپس، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل یاری یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری انجام خواهد شد.
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed.
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تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند.
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Secondary outcomes
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LDL-cholesterol
LDL-cholesterol
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کلسترول LDL
کلسترول LDL
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At the beginning of the study and after 6 weeks of intervention
At the beginning of the study and after 6 weeks of intervention
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در ابتدای مطالعه و 6 هفته بعد از مداخله
در ابتدای مطالعه و 6 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
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VLDL-cholesterol
VLDL-cholesterol
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کلسترول VLDL
کلسترول VLDL
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At the beginning of the study and after 6 weeks of intervention
At the beginning of the study and after 6 weeks of intervention
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در ابتدای مطالعه و 6 هفته بعد از مداخله
در ابتدای مطالعه و 6 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
Recruitment centers
#1
Name of recruitment center - English: Kosar Clinic
Name of recruitment center - Persian: کلینیک کوثر
Full name of responsible person - English: Mehri Jamilian
Full name of responsible person - Persian: مهری جمیلیان
Street address - English: Emam Khomeyni Avenue, Arak
Street address - Persian: اراک، خیابان امام خمینی
City - English: Arak
City - Persian: اراک
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Kosar Clinic
Name of recruitment center - Persian: کلینیک کوثر
Full name of responsible person - English: Mehri Jamilian
Full name of responsible person - Persian: مهری جمیلیان
Street address - English: Emam Khomeyni Avenue, Arak
Street address - Persian: اراک، خیابان امام خمینی
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 1771844351
Phone: +98 31 5546 3378
Fax:
Email: jamilian.mehri@gmail.com
Web page address:
Name of recruitment center - English: Kosar Clinic Name of recruitment center - Persian: کلینیک کوثر Full name of responsible person - English: Mehri Jamilian Full name of responsible person - Persian: مهری جمیلیان Street address - English: Emam Khomeyni Avenue, Arak Street address - Persian: اراک، خیابان امام خمینی City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 1771844351 Phone: +98 31 5546 3378 Fax: Email: jamilian.mehri@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Arak University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Mohammad Rafiee
Full name of responsible person - Persian: محمد رفیعی
Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
Street address - Persian: اراك، معاونت پژوهشی دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی
City - English: Arak
City - Persian: اراک
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: Mohammad Rafiee
Full name of responsible person - Persian: محمد رفیعی
Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
Street address - Persian: اراك، معاونت پژوهشی دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 1771844351
Phone: +98 31 5546 3378
Fax:
Email: Mohammad-Rafiee@Aums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Arak University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اراک Full name of responsible person - English: Mohammad Rafiee Full name of responsible person - Persian: محمد رفیعی Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak Street address - Persian: اراك، معاونت پژوهشی دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 1771844351 Phone: +98 31 5546 3378 Fax: Email: Mohammad-Rafiee@Aums.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Vice chancellor for research, Arak University of Medical Sciences
Arak University of Medical Sciences
Vice chancellor for research, Arak University of Medical Sciences
معاونت پژوهشی دانشگاه علوم پزشکی اراک
دانشگاه علوم پزشکی اراک
معاونت پژوهشی دانشگاه علوم پزشکی اراک
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English:
Full name of responsible person - Persian:
Position - English:
Position - Persian:
Latest degree:
Area of specialty/work:
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:
Country:
Postal code:
Phone:
Mobile:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1771844351
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_r@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: Associate professor Position - Persian: دانشیار Latest degree: phd Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1771844351 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_r@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1771844351
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_r@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: PhD of Nutrition Position - Persian: دکتری تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1771844351 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1771844351
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_r@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: PhD of Nutrition Position - Persian: دکتری تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1771844351 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
na
na
undecided
undecided
na
na
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
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست.
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست.
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of synbiotic supplementation on metabolic profiles in patients with gestational diabetes.
Design
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive synbiotic supplements (n=35) or placebo (n=35).
Settings and conduct
Among patients with gestational diabetes referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 70 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with gestational diabetes, aged 18 to 40 years.
Exclusion criteria: Taking synbiotic or probiotic including probiotic yogurt, kefir and other fermented foods, taking insulin, placenta abruption, pre-eclampsia, eclampsia, hypo and hyperthyroidism, smokers, kidney or liver diseases.
Intervention groups
Intervention group: Synbiotic capsule daily (Tak Gen Zist, Tehran, Iran) for 6 weeks orally. Control group: Placebo capsule (Tak Gen Zist, Tehran, Iran), for 6 weeks orally.
Main outcome variables
Outcomes: Insulin Metabolism (primary outcomes) and lipid profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201605085623N77
Registration date:2016-05-11, 1395/02/22
Registration timing:retrospective
Last update:2019-09-19, 1398/06/28
Update count:1
Registration date
2016-05-11, 1395/02/22
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of Synbiotic supplementation compared with the placebo on metabolic profiles in patients with gestational diabetes
Public title
Effect of supplementation in treatment of patients with gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with gestational diabetes
Aged 18 to 40 years
Exclusion criteria:
Taking synbiotic or probiotic including probiotic yogurt, kefir and other fermented foods
Taking insulin
Placenta abruption
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Smokers
Kidney or liver diseases
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed.
Placebo
Used
Assignment
Single
Other design features
Random assignment will be done by the use of computer-generated random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
1771844351
Approval date
2016-02-19, 1394/11/30
Ethics committee reference number
IR.ARAKMU.REC.1395.22
Health conditions studied
1
Description of health condition studied
Gestational diabetes
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Triglycerides
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
LDL-cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
VLDL-cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Intervention group: Probiotic supplements containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), 800 mg inulin, daily, for 6 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo, daily, for 6 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Clinic
Full name of responsible person
Mehri Jamilian
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
1771844351
Phone
+98 31 5546 3378
Email
jamilian.mehri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiee
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
1771844351
Phone
+98 31 5546 3378
Email
Mohammad-Rafiee@Aums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
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