Clinical trial of the effect of synbiotic supplementation compared with the placebo on metabolic profiles and biomarkers of oxidative stress in women with polycystic ovary syndrome
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Protocol summary
Objective: The aim of the current study is to evaluate the effects of synbiotic supplementation on metabolic profiles and biomarkers of oxidative stress in women with polycystic ovary syndrome (PCOS). Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment was done by the use of computer-generated random numbers. Inclusion and exclusion criteria: In the current study, women aged 18-40 years diagnosed with PCOS will be included. Unwillingness to cooperate and the use of antibiotic medications will be excluded in the study. Population and sample size: 60 patients with PCOS among women 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 (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12 weeks of intervention to measure metabolic profiles. Start and end date of intervention: 12 weeks (September 1, 2015-December 1, 2015). Outcomes: Metabolic profiles and biomarkers of oxidative stress will be measured at study baseline and after 12 weeks of intervention.
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Objective: The aim of the current study is to evaluate the effects of synbiotic supplementation on metabolic profiles and biomarkers of oxidative stress in women with polycystic ovary syndrome (PCOS). Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment was done by the use of computer-generated random numbers. Inclusion and exclusion criteria: In the current study, women aged 18-40 years diagnosed with PCOS will be included. Unwillingness to cooperate and the use of antibiotic medications will be excluded in the study. Population and sample size: 60 patients with PCOS among women 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 (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12 weeks of intervention to measure metabolic profiles. Start and end date of intervention: 12 weeks (September 1, 2015-December 1, 2015). Outcomes: Metabolic profiles and biomarkers of oxidative stress will be measured at study baseline and after 12 weeks of intervention.
هدف: هدف مطالعه حاضر ارزیابی اثرات مکمل یاری سین بیوتیک بر پروفایل های متابولیک و بیومارکرهای استرس اکسیداتیو در زنان مبتلا به سندروم تخمدان پلی کیستیک است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام می شود. معیار ورود و خروج مطالعه: در مطالعه حاضر، زنان 40-18 ساله مبتلا به سندروم تخمدان پلی کیستیک وارد خواهند شد. عدم تمایل به همکاری و مصرف داروهای آنتی بیوتیک از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به سندروم تخمدان پلی کیستیک در میان زنان 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 (گروه مداخله: 30n=) یا پلاسبو (گروه کنترل30n=) تقسیم خواهند شد. نمونه خون ناشتا در ابتدا و 12 هفته بعد از مداخله برای تعیین پروفایل های متابولیک گرفته خواهد شد. زمان شروع و اتمام مداخله: 12 هفته (از 10 شهریور 1394 تا 10 آذر 1394). پيامدها: پروفایل های متابولیک و بیومارکرهای استرس اکسیداتیو در ابتدا و 12 هفته بعد از مداخله اندازه گیری خواهد شد.
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هدف: هدف مطالعه حاضر ارزیابی اثرات مکمل یاری سین بیوتیک بر پروفایل های متابولیک و بیومارکرهای استرس اکسیداتیو در زنان مبتلا به سندروم تخمدان پلی کیستیک است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام می شود. معیار ورود و خروج مطالعه: در مطالعه حاضر، زنان 40-18 ساله مبتلا به سندروم تخمدان پلی کیستیک وارد خواهند شد. عدم تمایل به همکاری و مصرف داروهای آنتی بیوتیک از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به سندروم تخمدان پلی کیستیک در میان زنان 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 (گروه مداخله: 30n=) یا پلاسبو (گروه کنترل30n=) تقسیم خواهند شد. نمونه خون ناشتا در ابتدا و 12 هفته بعد از مداخله برای تعیین پروفایل های متابولیک گرفته خواهد شد. زمان شروع و اتمام مداخله: 12 هفته (از 10 شهریور 1394 تا 10 آذر 1394). پيامدها: پروفایل های متابولیک و بیومارکرهای استرس اکسیداتیو در ابتدا و 12 هفته بعد از مداخله اندازه گیری خواهد شد.
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The aim of the current study is to evaluate the effects of synbiotic supplementation on metabolic profiles and biomarkers of oxidative stress in women with polycystic ovary syndrome (PCOS).
The aim of the current study is to evaluate the effects of synbiotic supplementation on metabolic profiles and biomarkers of oxidative stress in women with polycystic ovary syndrome (PCOS).
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هدف مطالعه حاضر ارزیابی اثرات مکمل یاری سین بیوتیک بر پروفایل های متابولیک و بیومارکرهای استرس اکسیداتیو در زنان مبتلا به سندروم تخمدان پلی کیستیک است.
هدف مطالعه حاضر ارزیابی اثرات مکمل یاری سین بیوتیک بر پروفایل های متابولیک و بیومارکرهای استرس اکسیداتیو در زنان مبتلا به سندروم تخمدان پلی کیستیک است.
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Random assignment was done by the use of computer-generated random numbers.Population and sample size: 60 patients with PCOS among women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Random assignment was done by the use of computer-generated random numbers.Population and sample size: 60 patients with PCOS among women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام می شود. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به سندروم تخمدان پلی کیستیک در میان زنان واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام می شود. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به سندروم تخمدان پلی کیستیک در میان زنان واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
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60 patients with PCOS among women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
60 patients with PCOS among women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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60 بیمار مبتلا به سندروم تخمدان پلی کیستیک در میان زنان واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
60 بیمار مبتلا به سندروم تخمدان پلی کیستیک در میان زنان واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
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In the current study, women aged 18-40 years diagnosed with PCOS will be included. Unwillingness to cooperate and the use of antibiotic medications will be excluded in the study.
In the current study, women aged 18-40 years diagnosed with PCOS will be included. Unwillingness to cooperate and the use of antibiotic medications will be excluded in the study.
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معیار ورود و خروج مطالعه: در مطالعه حاضر، زنان 40-18 ساله مبتلا به سندروم تخمدان پلی کیستیک وارد خواهند شد. عدم تمایل به همکاری و مصرف داروهای آنتی بیوتیک از مطالعه خارج خواهند شد.
معیار ورود و خروج مطالعه: در مطالعه حاضر، زنان 40-18 ساله مبتلا به سندروم تخمدان پلی کیستیک وارد خواهند شد. عدم تمایل به همکاری و مصرف داروهای آنتی بیوتیک از مطالعه خارج خواهند شد.
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Patients will be assigned to receive either synbiotic supplements (intervention group: n=30) or placebo (control group: n=30).
Patients will be assigned to receive either synbiotic supplements (intervention group: n=30) or placebo (control group: n=30).
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بیماران برای دریافت مکمل سین بیوتیک (گروه مداخله: 30n=) یا پلاسبو (گروه کنترل30n=) تقسیم خواهند شد.
بیماران برای دریافت مکمل سین بیوتیک (گروه مداخله: 30n=) یا پلاسبو (گروه کنترل30n=) تقسیم خواهند شد.
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Outcomes: Metabolic profiles and biomarkers of oxidative stress will be measured at study baseline and after 12 weeks of intervention.
Outcomes: Metabolic profiles and biomarkers of oxidative stress will be measured at study baseline and after 12 weeks of intervention.
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پروفایل های متابولیک و بیومارکرهای استرس اکسیداتیو در ابتدا و 12 هفته بعد از مداخله اندازه گیری خواهد شد.
پروفایل های متابولیک و بیومارکرهای استرس اکسیداتیو در ابتدا و 12 هفته بعد از مداخله اندازه گیری خواهد شد.
General information
1
1
1
1
Women aged 18-40 years
Diagnosed with PCOS
Women aged 18-40 years Diagnosed with PCOS
زنان 40-18 ساله
تشخیص داده شده به سندروم تخمدان پلی کیستیک
زنان 40-18 ساله تشخیص داده شده به سندروم تخمدان پلی کیستیک
Unwillingness to cooperate
The use of antibiotic medications
Unwillingness to cooperate The use of antibiotic medications
عدم تمایل به همکاری
مصرف داروهای آنتی بیوتیک
عدم تمایل به همکاری مصرف داروهای آنتی بیوتیک
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Simple randomization
Simple randomization
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تصادفی سازی ساده
تصادفی سازی ساده
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Placebo has been used to achieve masking of participants and investigators. The researchers and patients will be concealed until the final analyses by a trained staff.
Placebo has been used to achieve masking of participants and investigators. The researchers and patients will be concealed until the final analyses by a trained staff.
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از پلاسبو برای کور سازی استفاده شده است. محققان و بیماران کور تا زمان آنالیز نهایی توسط یک کارمند آموزش دیده خواهند شد.
از پلاسبو برای کور سازی استفاده شده است. محققان و بیماران کور تا زمان آنالیز نهایی توسط یک کارمند آموزش دیده خواهند شد.
Health conditions studied
#1
Polycystic ovary syndrome
Polycystic ovarian syndrome
Polycystic ovaryovarian syndrome
Primary outcomes
#1
Insulin
Hs-CRP
InsulinHs-CRP
انسولین
پروتئین واکنشگر C با حساسیت بالا
انسولینپروتئین واکنشگر C با حساسیت بالا
#2
Insulin resistance
Nitric oxide
Insulin resistanceNitric oxide
مقاومت به انسولین
نیتریک اکساید
مقاومت به انسولیننیتریک اکساید
Elisa kit
Spectrophotometry
Elisa kitSpectrophotometry
کیت الایزا
اسپکتروفتومتری
کیت الایزااسپکتروفتومتری
Secondary outcomes
#1
Triglycerides
Serum dehydroepiandrosterone
TriglyceridesSerum dehydroepiandrosterone
تری گلیسرید
دی هیدرواپی آندرسترون سرمی
تری گلیسریددی هیدرواپی آندرسترون سرمی
Enzymatic kit
Elisa kit
EnzymaticElisa kit
کیت آنزیمی
کیت الایزا
کیت آنزیمیالایزا
#2
Total cholesterol
Serum total testosterone
Total cholesterolSerum total testosterone
کلسترول تام
توتال تستوسترون سرمی
کلسترول تامتوتال تستوسترون سرمی
Enzymatic kit
Elisa kit
EnzymaticElisa kit
کیت آنزیمی
کیت الایزا
کیت آنزیمیالایزا
#3
HDL-cholesterol
Plasma malondialdehyde
HDL-cholesterolPlasma malondialdehyde
کلسترول HDL
مالون دی آلدئید پلاسمایی
کلسترول HDLمالون دی آلدئید پلاسمایی
Enzymatic kit
Spectrophotometry
Enzymatic kitSpectrophotometry
کیت آنزیمی
اسپکتروفتومتری
کیت آنزیمیاسپکتروفتومتری
#4
Total antioxidant
Plasma total antioxidant capacity
TotalPlasma total antioxidant capacity
آنتی اکسیدانت توتال
آنتی اکسیدانت توتال پلاسمایی
آنتی اکسیدانت توتال پلاسمایی
#5
Glutathione
Plasma glutathione
GlutathionePlasma glutathione
گلوتاتیون
گلوتاتیون پلاسمایی
گلوتاتیون پلاسمایی
Recruitment centers
#1
Name of recruitment center - English: Kosar Clinic
Name of recruitment center - Persian: کلینیک کوثر
Full name of responsible person - English: Khadijeh Nasri
Full name of responsible person - Persian: خدیجه نصری
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: Khadijeh Nasri
Full name of responsible person - Persian: خدیجه نصری
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: 8715988141
Phone: +98 86 2769 3000
Fax:
Email: khadijeh.nasri2@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: Khadijeh Nasri Full name of responsible person - Persian: خدیجه نصری 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: 8715988141 Phone: +98 86 2769 3000 Fax: Email: khadijeh.nasri2@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، خیابان سردشت، معاونت آموزش و تحقيقات
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، خیابان سردشت، معاونت آموزش و تحقيقات
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 86 3276 9300
Fax:
Email: rafiee.mohammad22@gmail.com
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، خیابان سردشت، معاونت آموزش و تحقيقات City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 8715988141 Phone: +98 86 3276 9300 Fax: Email: rafiee.mohammad22@gmail.com Web page address:
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Public
public
empty
Domestic
domestic
empty
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: 8715988141
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: 8715988141 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: دکترای 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: دکترای 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: 8715988141
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
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: دکترای 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: 8715988141 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: 8715988141
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
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: 8715988141 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
no
no
no
no
na
na
undecided
undecided
na
na
na
na
na
na
empty
Not
Not
empty
خیر
خیر
Protocol summary
Study aim
The aim of the current study is to evaluate the effects of synbiotic supplementation on metabolic profiles and biomarkers of oxidative stress in women with polycystic ovary syndrome (PCOS).
Design
Random assignment was done by the use of computer-generated random numbers.Population and sample size: 60 patients with PCOS among women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Settings and conduct
60 patients with PCOS among women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
In the current study, women aged 18-40 years diagnosed with PCOS will be included. Unwillingness to cooperate and the use of antibiotic medications will be excluded in the study.
Intervention groups
Patients will be assigned to receive either synbiotic supplements (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Outcomes: Metabolic profiles and biomarkers of oxidative stress will be measured at study baseline and after 12 weeks of intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201509115623N53
Registration date:2015-09-27, 1394/07/05
Registration timing:retrospective
Last update:2018-03-10, 1396/12/19
Update count:2
Registration date
2015-09-27, 1394/07/05
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
2015-08-23, 1394/06/01
Expected recruitment end date
2015-09-01, 1394/06/10
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 and biomarkers of oxidative stress in women with polycystic ovary syndrome
Public title
Effect of supplementation in treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18-40 years
Diagnosed with PCOS
Exclusion criteria:
Unwillingness to cooperate
The use of antibiotic medications
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo has been used to achieve masking of participants and investigators. The researchers and patients will be concealed until the final analyses by a trained staff.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
8715988141
Approval date
2015-08-23, 1394/06/01
Ethics committee reference number
IR.ARAKMU.REC.1394.160
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Serum dehydroepiandrosterone
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
3
Description
Serum total testosterone
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
4
Description
Plasma malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Plasma total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Plasma glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: Synbiotic capsule, Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g) plus 0.8 g inulin, daily, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule, daily, for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Clinic
Full name of responsible person
Khadijeh Nasri
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
8715988141
Phone
+98 86 2769 3000
Email
khadijeh.nasri2@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
8715988141
Phone
+98 86 3276 9300
Email
rafiee.mohammad22@gmail.com
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
8715988141
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
8715988141
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
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
8715988141
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Not
Study Protocol
No - There is not 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