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Protocol summary
Objective: The aim of this study is to determine the effects of soy intake on metabolic profiles in patients with polycystic ovary syndrome. Study design: Parallel randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with polycystic ovary syndrome 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: 60 patients with polycystic ovary syndrome of eligible and referred to Akbarabadi Hospital affiliated to Iran University of Medical Sciences, Tehran, Iran in the study will be selected. Intervention: Patients will be assigned to receive either soy plus low calorie diet (n=30) or control plus low calorie diet (n=30). Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and end of the intervention: 8 weeks. Outcomes: Insulin metabolism (primary outcomes), lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) 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 soy intake on metabolic profiles in patients with polycystic ovary syndrome. Study design: Parallel randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with polycystic ovary syndrome 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: 60 patients with polycystic ovary syndrome of eligible and referred to Akbarabadi Hospital affiliated to Iran University of Medical Sciences, Tehran, Iran in the study will be selected. Intervention: Patients will be assigned to receive either soy plus low calorie diet (n=30) or control plus low calorie diet (n=30). Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and end of the intervention: 8 weeks. Outcomes: Insulin metabolism (primary outcomes), lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات دریافت سویا بر پروفایل های متابولیک در بیماران مبتلا به سندروم تخمدان پلی کیستیک است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک 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: 60 بیمار مبتلا به سندروم تخمدان پلی کیستیک واجد شرایط و ارجاع شده به بیمارستان اکبرآبادی وابسته به دانشگاه علوم پزشکی ایران، تهران، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا سویا بعلاوه رژیم کاهش وزن (30=n) یا کنترل بعلاوه رژیم کاهش وزن (30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته. پيامدها: متابولیسم انسولین (پیامدهای اولیه)، پروفایل های لیپیدی، بیومارکرهای التهابی و استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات دریافت سویا بر پروفایل های متابولیک در بیماران مبتلا به سندروم تخمدان پلی کیستیک است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک 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: 60 بیمار مبتلا به سندروم تخمدان پلی کیستیک واجد شرایط و ارجاع شده به بیمارستان اکبرآبادی وابسته به دانشگاه علوم پزشکی ایران، تهران، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا سویا بعلاوه رژیم کاهش وزن (30=n) یا کنترل بعلاوه رژیم کاهش وزن (30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته. پيامدها: متابولیسم انسولین (پیامدهای اولیه)، پروفایل های لیپیدی، بیومارکرهای التهابی و استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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The aim of this study is to determine the effects of soy intake on metabolic profiles in patients with polycystic ovary syndrome.
The aim of this study is to determine the effects of soy intake on metabolic profiles in patients with polycystic ovary syndrome.
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هدف این مطالعه تعیین اثرات دریافت سویا بر پروفایل های متابولیک در بیماران مبتلا به سندروم تخمدان پلی کیستیک است.
هدف این مطالعه تعیین اثرات دریافت سویا بر پروفایل های متابولیک در بیماران مبتلا به سندروم تخمدان پلی کیستیک است.
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Study design: Parallel randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
Study design: Parallel randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
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طراحي انجام مطالعه: تصادفي کارآزمایی بالینی موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
طراحي انجام مطالعه: تصادفي کارآزمایی بالینی موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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Population and sample size: 60 patients with polycystic ovary syndrome of eligible and referred to Akbarabadi Hospital affiliated to Iran University of Medical Sciences, Tehran, Iran in the study will be selected.
Population and sample size: 60 patients with polycystic ovary syndrome of eligible and referred to Akbarabadi Hospital affiliated to Iran University of Medical Sciences, Tehran, Iran in the study will be selected.
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حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به سندروم تخمدان پلی کیستیک واجد شرایط و ارجاع شده به بیمارستان اکبرآبادی وابسته به دانشگاه علوم پزشکی ایران، تهران، ایران در مطالعه انتخاب خواهند شد.
حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به سندروم تخمدان پلی کیستیک واجد شرایط و ارجاع شده به بیمارستان اکبرآبادی وابسته به دانشگاه علوم پزشکی ایران، تهران، ایران در مطالعه انتخاب خواهند شد.
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Inclusion criteria: Patients with PCOS according to Rotterdam criteria and aged 18 to 40 years will be included in this study. Exclusion criteria: Pregnant women Hyperprolactinaemia Thyroid dysfunction Endocrine diseases including diabetes, impaired glucose tolerance and gastrointestinal problems Took medications, such as hormonal contraceptives, insulin sensitising agents, anti-inflammatory or antidiabetic and lipid lowering drugs, or any other medications that might affect reproductive physiology during the 8-week intervention.
Inclusion criteria: Patients with PCOS according to Rotterdam criteria and aged 18 to 40 years will be included in this study. Exclusion criteria: Pregnant women Hyperprolactinaemia Thyroid dysfunction Endocrine diseases including diabetes, impaired glucose tolerance and gastrointestinal problems Took medications, such as hormonal contraceptives, insulin sensitising agents, anti-inflammatory or antidiabetic and lipid lowering drugs, or any other medications that might affect reproductive physiology during the 8-week intervention.
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معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام و در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: زنان باردار هایپروپرولاکتینمی اختلال عملکرد تیروئید بیماری های غدد درون ریز از جمله دیابت، اختلال در تحمل گلوکز و مشکلات دستگاه گوارش مصرف داروهایی مانند داروهای ضد بارداری هورمونی ، داروهای حساس به انسولین، داروهای ضد التهاب یا ضد دیابتی و کاهش چربی، یا هر داروی دیگری که ممکن است در طول 8 هفته مداخله بر فیزیولوژی تولید مثل اثر داشته باشد.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام و در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: زنان باردار هایپروپرولاکتینمی اختلال عملکرد تیروئید بیماری های غدد درون ریز از جمله دیابت، اختلال در تحمل گلوکز و مشکلات دستگاه گوارش مصرف داروهایی مانند داروهای ضد بارداری هورمونی ، داروهای حساس به انسولین، داروهای ضد التهاب یا ضد دیابتی و کاهش چربی، یا هر داروی دیگری که ممکن است در طول 8 هفته مداخله بر فیزیولوژی تولید مثل اثر داشته باشد.
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Intervention: Patients will be assigned to receive either soy plus low calorie diet (n=30) or control plus low calorie diet (n=30).
Intervention: Patients will be assigned to receive either soy plus low calorie diet (n=30) or control plus low calorie diet (n=30).
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مداخله مورد مطالعه: بیماران برای دریافت یا سویا بعلاوه رژیم کاهش وزن (30=n) یا کنترل بعلاوه رژیم کاهش وزن (30=n) تقسیم خواهند شد.
مداخله مورد مطالعه: بیماران برای دریافت یا سویا بعلاوه رژیم کاهش وزن (30=n) یا کنترل بعلاوه رژیم کاهش وزن (30=n) تقسیم خواهند شد.
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Insulin metabolism (primary outcomes), lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
Insulin metabolism (primary outcomes), lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
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متابولیسم انسولین (پیامدهای اولیه)، پروفایل های لیپیدی، بیومارکرهای التهابی و استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
متابولیسم انسولین (پیامدهای اولیه)، پروفایل های لیپیدی، بیومارکرهای التهابی و استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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Aged18–40 years old
Patients with PCOS according to Rotterdam criteria
Aged18–40 years old Patients with PCOS according to Rotterdam criteria
در محدوده سنی 18 تا 40 سال
بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام
در محدوده سنی 18 تا 40 سال بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام
Pregnant women
Hyperprolactinaemia
Thyroid dysfunction
Endocrine diseases including diabetes, impaired glucose tolerance and gastrointestinal problems
Took medications, such as hormonal contraceptives, insulin sensitising agents, anti-inflammatory or antidiabetic and lipid lowering drugs, or any other medications that might affect reproductive physiology during the 8-week intervention.
Pregnant women Hyperprolactinaemia Thyroid dysfunction Endocrine diseases including diabetes, impaired glucose tolerance and gastrointestinal problems Took medications, such as hormonal contraceptives, insulin sensitising agents, anti-inflammatory or antidiabetic and lipid lowering drugs, or any other medications that might affect reproductive physiology during the 8-week intervention.
زنان باردار
هایپروپرولاکتینمی
اختلال عملکرد تیروئید
بیماری های غدد درون ریز از جمله دیابت، اختلال در تحمل گلوکز و مشکلات دستگاه گوارش
مصرف داروهایی مانند داروهای ضد بارداری هورمونی ، داروهای حساس به انسولین، داروهای ضد التهاب یا ضد دیابتی و کاهش چربی، یا هر داروی دیگری که ممکن است در طول 8 هفته مداخله بر فیزیولوژی تولید مثل اثر داشته باشد.
زنان باردار هایپروپرولاکتینمی اختلال عملکرد تیروئید بیماری های غدد درون ریز از جمله دیابت، اختلال در تحمل گلوکز و مشکلات دستگاه گوارش مصرف داروهایی مانند داروهای ضد بارداری هورمونی ، داروهای حساس به انسولین، داروهای ضد التهاب یا ضد دیابتی و کاهش چربی، یا هر داروی دیگری که ممکن است در طول 8 هفته مداخله بر فیزیولوژی تولید مثل اثر داشته باشد.
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either soy supplements (n=30) or placebo (n=30). Randomization will be done by the use of computer-generated random numbers.
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either soy supplements (n=30) or placebo (n=30). Randomization will be done by the use of computer-generated random numbers.
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در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل سویا (n=30) و پلاسبو (n=30) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل سویا (n=30) و پلاسبو (n=30) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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Primary outcomes
#1
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Insulin sensitivity
Insulin sensitivity
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حساسیت به انسولین
حساسیت به انسولین
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At the beginning of the study and after 8 weeks of intervention
At the beginning of the study and after 8 weeks of intervention
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در ابتدای مطالعه و 8 هفته بعد از مداخله
در ابتدای مطالعه و 8 هفته بعد از مداخله
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Using QUICKI formula
Using QUICKI formula
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با استفاده از فرمول QUICKI
با استفاده از فرمول QUICKI
Secondary outcomes
#1
اسکتروفتومتری
اسپکتروفتومتری
اسکتروفتومتریاسپکتروفتومتری
#2
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Glutathione
Glutathione
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گلوتاتیون
گلوتاتیون
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At the beginning of the study and after 8 weeks of intervention
At the beginning of the study and after 8 weeks of intervention
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در ابتدای مطالعه و 8 هفته بعد از مداخله
در ابتدای مطالعه و 8 هفته بعد از مداخله
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Spectrophotometry
Spectrophotometry
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اسپکتروفتومتری
اسپکتروفتومتری
#3
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Nitric oxide
Nitric oxide
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نیتریک اکساید
نیتریک اکساید
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At the beginning of the study and after 8 weeks of intervention
At the beginning of the study and after 8 weeks of intervention
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در ابتدای مطالعه و 8 هفته بعد از مداخله
در ابتدای مطالعه و 8 هفته بعد از مداخله
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Spectrophotometry
Spectrophotometry
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اسپکتروفتومتری
اسپکتروفتومتری
Recruitment centers
#1
Name of recruitment center - English: Akbarabadi Clinic
Name of recruitment center - Persian: کلینیک اکبرآبادی
Full name of responsible person - English: Maryam Karamali
Full name of responsible person - Persian: مریم کرمعلی
Street address - English: Akbarabadi Hospital, Mowlavi Street, Tehran
Street address - Persian: تهران، خیابان مولوی، بیمارستان اکبرآبادی
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Akbarabadi Clinic
Name of recruitment center - Persian: کلینیک اکبرآبادی
Full name of responsible person - English: Maryam Karamali
Full name of responsible person - Persian: مریم کرمعلی
Street address - English: Akbarabadi Hospital, Mowlavi Street, Tehran
Street address - Persian: تهران، خیابان مولوی، بیمارستان اکبرآبادی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 8612780660
Phone: +98 86 1278 0660
Fax: +98 86 1278 8301
Email: dr.karamali@arakmu.ac.ir
Web page address:
Name of recruitment center - English: Akbarabadi Clinic Name of recruitment center - Persian: کلینیک اکبرآبادی Full name of responsible person - English: Maryam Karamali Full name of responsible person - Persian: مریم کرمعلی Street address - English: Akbarabadi Hospital, Mowlavi Street, Tehran Street address - Persian: تهران، خیابان مولوی، بیمارستان اکبرآبادی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 8612780660 Phone: +98 86 1278 0660 Fax: +98 86 1278 8301 Email: dr.karamali@arakmu.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Iran University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Seyed Ali Javad Moosavi
Full name of responsible person - Persian: سيد علي جواد موسوي
Street address - English: Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
Street address - Persian: تهران، بزرگراه همت، معاونت پژوهشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
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 research, Iran University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Seyed Ali Javad Moosavi
Full name of responsible person - Persian: سيد علي جواد موسوي
Street address - English: Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
Street address - Persian: تهران، بزرگراه همت، معاونت پژوهشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 55606034
Phone: +98 21 5560 6034
Fax:
Email: mosavi-sj@iums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Iran University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران Full name of responsible person - English: Seyed Ali Javad Moosavi Full name of responsible person - Persian: سيد علي جواد موسوي Street address - English: Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran Street address - Persian: تهران، بزرگراه همت، معاونت پژوهشی دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 55606034 Phone: +98 21 5560 6034 Fax: Email: mosavi-sj@iums.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
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: 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: 8115187159
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: 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: 8115187159 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: 00
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: 8115187159
Phone: +98 31 5546 3378
Mobile: 009133615446
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: 8115187159 Phone: +98 31 5546 3378 Mobile: 00009133615446 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: 00
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: 8115187159
Phone: +98 31 5546 3378
Mobile: 009133615446
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: 8115187159 Phone: +98 31 5546 3378 Mobile: 00009133615446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
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
The aim of this study is to determine the effects of soy intake on metabolic profiles in patients with polycystic ovary syndrome.
Design
Study design: Parallel randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
Settings and conduct
Population and sample size: 60 patients with polycystic ovary syndrome of eligible and referred to Akbarabadi Hospital affiliated to Iran University of Medical Sciences, Tehran, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with PCOS according to Rotterdam criteria and aged 18 to 40 years will be included in this study. Exclusion criteria: Pregnant women Hyperprolactinaemia Thyroid dysfunction Endocrine diseases including diabetes, impaired glucose tolerance and gastrointestinal problems Took medications, such as hormonal contraceptives, insulin sensitising agents, anti-inflammatory or antidiabetic and lipid lowering drugs, or any other medications that might affect reproductive physiology during the 8-week intervention.
Intervention groups
Intervention: Patients will be assigned to receive either soy plus low calorie diet (n=30) or control plus low calorie diet (n=30).
Main outcome variables
Insulin metabolism (primary outcomes), lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201701295623N104
Registration date:2017-02-01, 1395/11/13
Registration timing:retrospective
Last update:2019-09-23, 1398/07/01
Update count:1
Registration date
2017-02-01, 1395/11/13
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
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-01-17, 1395/10/28
Expected recruitment end date
2017-01-24, 1395/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of soy intake compared with the control diet on metabolic profiles in patients with polycystic ovary syndrome
Public title
Effect of diet therapy in treatment of patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged18–40 years old
Patients with PCOS according to Rotterdam criteria
Exclusion criteria:
Pregnant women
Hyperprolactinaemia
Thyroid dysfunction
Endocrine diseases including diabetes, impaired glucose tolerance and gastrointestinal problems
Took medications, such as hormonal contraceptives, insulin sensitising agents, anti-inflammatory or antidiabetic and lipid lowering drugs, or any other medications that might affect reproductive physiology during the 8-week intervention.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either soy supplements (n=30) or placebo (n=30). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-01-16, 1395/10/27
Ethics committee reference number
IR.IUMS.REC.1395.26552
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
Insulin
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Using HOMA formula
3
Description
Insulin sensitivity
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Using QUICKI formula
Secondary outcomes
1
Description
Hs-CRP
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Elisa kit
2
Description
HDL
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Triglycerides
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Total cholesterol
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Total antioxidant
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Glutathione
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Nitric oxide
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: Soy-protein diet, 0.8 g/kg protein (35% animal protein, 35% soy protein, and 30% other vegetable proteins), daily for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: Standard diet, 0.8 g/kg protein (70% animal and 30% vegetable proteins), daily for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Clinic
Full name of responsible person
Maryam Karamali
Street address
Akbarabadi Hospital, Mowlavi Street, Tehran
City
Tehran
Province
Tehran
Postal code
8612780660
Phone
+98 86 1278 0660
Fax
+98 86 1278 8301
Email
dr.karamali@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
55606034
Phone
+98 21 5560 6034
Email
mosavi-sj@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran 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
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
8115187159
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
8115187159
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
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available