Clinical trial of the effect of probiotic honey supplementation compared with the control honey on metabolic profiles in patients with diabetic nephropathy
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Protocol summary
Objective: The aim of this study is to determine the effects of probiotic honey supplementation on metabolic profiles including insulin resistance and lipid profiles in patients with diabetic nephropathy. 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 diabetic nephropathy and aged 40 to 80 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 diabetic nephropathy of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either probiotic honey (n=30) or control honey (n=30). Probiotic and control honey are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Insulin metabolism parameters (primary outcomes) and lipid profiles (secondry outcomes) 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 probiotic honey supplementation on metabolic profiles including insulin resistance and lipid profiles in patients with diabetic nephropathy. 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 diabetic nephropathy and aged 40 to 80 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 diabetic nephropathy of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either probiotic honey (n=30) or control honey (n=30). Probiotic and control honey are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Insulin metabolism parameters (primary outcomes) and lipid profiles (secondry outcomes) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری عسل پروبیوتیک بر پروفایل های متابولیک از قبیل مقاومت به انسولین و پروفایل های لیپیدی در بیماران مبتلا به نفروپاتی دیابتیک 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 نفروپاتی دیابتیک در محدوده سنی 40 تا 80 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 نفروپاتی دیابتیک واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا مکمل عسل پروبیوتیک (30=n) یا عسل کنترل (30=n) تقسیم خواهند شد. عسل پروبیوتیک و کنترل از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: پارامترهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری عسل پروبیوتیک بر پروفایل های متابولیک از قبیل مقاومت به انسولین و پروفایل های لیپیدی در بیماران مبتلا به نفروپاتی دیابتیک 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 نفروپاتی دیابتیک در محدوده سنی 40 تا 80 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 نفروپاتی دیابتیک واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا مکمل عسل پروبیوتیک (30=n) یا عسل کنترل (30=n) تقسیم خواهند شد. عسل پروبیوتیک و کنترل از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: پارامترهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی (پیامدهای ثانویه) 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 probiotic honey supplementation on metabolic profiles including insulin resistance and lipid profiles in patients with diabetic nephropathy.
Objective: The aim of this study is to determine the effects of probiotic honey supplementation on metabolic profiles including insulin resistance and lipid profiles in patients with diabetic nephropathy.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری عسل پروبیوتیک بر پروفایل های متابولیک از قبیل مقاومت به انسولین و پروفایل های لیپیدی در بیماران مبتلا به نفروپاتی دیابتیک است.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری عسل پروبیوتیک بر پروفایل های متابولیک از قبیل مقاومت به انسولین و پروفایل های لیپیدی در بیماران مبتلا به نفروپاتی دیابتیک است.
مطالعه کارآزمایی بالینی تصادفي، دو سوكور کور، کنترل شده با پلاسبو، فاز 3، 60 بیمار
مطالعه کارآزمایی بالینی تصادفي، دو سوكور کور، کنترل شده با پلاسبو، فاز 3، 60 بیمار
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60 patients with diabetic nephropathy of eligible and referred to Akhavan Clinic, Kashan, Iran in the study will be selected.
60 patients with diabetic nephropathy of eligible and referred to Akhavan Clinic, Kashan, Iran in the study will be selected.
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60 بیمار مبتلا به نفروپاتی دیابتیک واجد شرایط و ارجاع شده به کلینیک اخوان، کاشان، ایران در مطالعه انتخاب خواهند شد.
60 بیمار مبتلا به نفروپاتی دیابتیک واجد شرایط و ارجاع شده به کلینیک اخوان، کاشان، ایران در مطالعه انتخاب خواهند شد.
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Patients with diabetic nephropathy with a proteinuria level>0.3 g/24 h, with or without elevation of serum creatinine levels and aged 45 to 85 years will be included in this study. Exclusion criteria: History of active infection within 3 months, the intake of probiotic and/or synbiotic supplements within 3 months and malignancy and/or liver cirrhosis.
Patients with diabetic nephropathy with a proteinuria level>0.3 g/24 h, with or without elevation of serum creatinine levels and aged 45 to 85 years will be included in this study. Exclusion criteria: History of active infection within 3 months, the intake of probiotic and/or synbiotic supplements within 3 months and malignancy and/or liver cirrhosis.
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بیماران مبتلا به نفروپاتی دیابتیک با سطح پروتئینوری> 0.3 گرم در 24 ساعت ، با یا بدون افزایش سطح کراتینین سرم و در محدوده سنی 45 تا 85 سال وارد مطالعه خواهند شد. معیارهای خروج به شرح زیر است: سابقه عفونت فعال، دریافت مکمل های پروبیوتیک و/یا سین بیوتیک در طی سه ماه گذشته، بدخیمی و/یا سیروز کبدی.
بیماران مبتلا به نفروپاتی دیابتیک با سطح پروتئینوری> 0.3 گرم در 24 ساعت ، با یا بدون افزایش سطح کراتینین سرم و در محدوده سنی 45 تا 85 سال وارد مطالعه خواهند شد. معیارهای خروج به شرح زیر است: سابقه عفونت فعال، دریافت مکمل های پروبیوتیک و/یا سین بیوتیک در طی سه ماه گذشته، بدخیمی و/یا سیروز کبدی.
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Intervention: Patients will be assigned to receive either probiotic honey (n=30) or control honey (n=30). Probiotic and control honey are similar in shape and size.
Intervention: Patients will be assigned to receive either probiotic honey (n=30) or control honey (n=30). Probiotic and control honey are similar in shape and size.
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مداخله مورد مطالعه: بیماران برای دریافت یا مکمل عسل پروبیوتیک (30=n) یا عسل کنترل (30=n) تقسیم خواهند شد. عسل پروبیوتیک و کنترل از نظر شکل و اندازه مشابه هستند.
مداخله مورد مطالعه: بیماران برای دریافت یا مکمل عسل پروبیوتیک (30=n) یا عسل کنترل (30=n) تقسیم خواهند شد. عسل پروبیوتیک و کنترل از نظر شکل و اندازه مشابه هستند.
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Outcomes: Insulin metabolism parameters (primary outcomes) and lipid profiles (secondry outcomes) will be quantified at study baseline and end-of-trial.
Outcomes: Insulin metabolism parameters (primary outcomes) and lipid profiles (secondry outcomes) will be quantified at study baseline and end-of-trial.
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پيامدها: پارامترهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: پارامترهای 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 diabetic nephropathy
Aged 40 to 80 years
Proteinuria level>0.3 g/24 h, with or without elevation of serum creatinine levels
Patients with diabetic nephropathy Aged 40 to 80 years Proteinuria level>0.3 g/24 h, with or without elevation of serum creatinine levels
بیماران مبتلا به نفروپاتی دیابتیک
در محدوده سنی 45 تا 85 سال
سطح پروتئینوری بیشتر از 0/3 گرم در 24 ساعت، با یا بدون افزایش سطح سرمی کراتین
بیماران مبتلا به نفروپاتی دیابتیک در محدوده سنی 45 تا 85 سال سطح پروتئینوری بیشتر از 0/3 گرم در 24 ساعت، با یا بدون افزایش سطح سرمی کراتین
History of active infection within 3 months
The intake of probiotic and/or synbiotic supplements within 3 months
Malignancy and/or liver cirrhosis
History of active infection within 3 months The intake of probiotic and/or synbiotic supplements within 3 months Malignancy and/or liver cirrhosis
سابقه عفونت فعال
دریافت مکمل های پروبیوتیک و/یا سین بیوتیک در طی سه ماه گذشته
بدخیمی و/یا سیروز کبدی
سابقه عفونت فعال دریافت مکمل های پروبیوتیک و/یا سین بیوتیک در طی سه ماه گذشته بدخیمی و/یا سیروز کبدی
Random assignment will be done by the use of computer-generated random numbers.
Random assignment will be done by the use of computer-generated random numbers.
تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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To decrease potential confounding effects, after balanced blocked randomisation, all participants will have allocated into two treatment groups to take either probiotic honey or normal honey. Randomization will be done by the use of Stat Trek software.
To decrease potential confounding effects, after balanced blocked randomisation, all participants will have allocated into two treatment groups to take either probiotic honey or normal honey. Randomization will be done by the use of Stat Trek software.
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برای کاهش اثرات مخدوش کنندگی بالقوه، بعد از تصادفی سازی بلوکی بالانس شده، همه شرکت کنندگان برای دریافت عسل پروبیوتیک یا عسل معمولی تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار Stat Trek انجام می شود.
برای کاهش اثرات مخدوش کنندگی بالقوه، بعد از تصادفی سازی بلوکی بالانس شده، همه شرکت کنندگان برای دریافت عسل پروبیوتیک یا عسل معمولی تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار Stat Trek انجام می شود.
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Akhavan Clinic in Kashan who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Akhavan Clinic in Kashan who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک اخوان در کاشان که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک اخوان در کاشان که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
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Secondary outcomes
#1
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FPG
FPG
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قند خون ناشتا
قند خون ناشتا
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#2
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LDL
LDL
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LDL
LDL
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 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: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Akhavan Clinic
Name of recruitment center - Persian: کلینیک اخوان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5546 3378
Fax:
Email: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: NaghaviAkhavan Clinic Name of recruitment center - Persian: کلینیک نقویاخوان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Street address - English: Shahid Rajaee Avenue, Kashan Street address - Persian: کاشان، خیابان شهید رجایی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5546 3378 Fax: Email: asemi_r@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
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, Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5546 3378
Fax:
Email: hamidi-gh@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Gholamali Hamidi Full name of responsible person - Persian: غلامعلی حمیدی Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5546 3378 Fax: Email: hamidi-gh@kaums.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: 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: 81151-87159
Phone: +98 31 5546 3378
Mobile: 00
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: 81151-87159 Phone: +98 31 5546 3378 Mobile: 00 Fax: Email: asemi_z@kaums.ac.ir; 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: 81151-87159
Phone: +98 31 5546 3378
Mobile: 00
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: 81151-87159 Phone: +98 31 5546 3378 Mobile: 00 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: 81151-87159
Phone: +98 31 5546 3378
Mobile: 00
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: 81151-87159 Phone: +98 31 5546 3378 Mobile: 00 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
Objective: The aim of this study is to determine the effects of probiotic honey supplementation on metabolic profiles including insulin resistance and lipid profiles in patients with diabetic nephropathy.
60 patients with diabetic nephropathy of eligible and referred to Akhavan Clinic, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Patients with diabetic nephropathy with a proteinuria level>0.3 g/24 h, with or without elevation of serum creatinine levels and aged 45 to 85 years will be included in this study. Exclusion criteria: History of active infection within 3 months, the intake of probiotic and/or synbiotic supplements within 3 months and malignancy and/or liver cirrhosis.
Intervention groups
Intervention: Patients will be assigned to receive either probiotic honey (n=30) or control honey (n=30). Probiotic and control honey are similar in shape and size.
Main outcome variables
Outcomes: Insulin metabolism parameters (primary outcomes) and lipid profiles (secondry outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201705035623N115
Registration date:2017-05-29, 1396/03/08
Registration timing:retrospective
Last update:2019-09-22, 1398/06/31
Update count:1
Registration date
2017-05-29, 1396/03/08
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, Kashan University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-05-20, 1396/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of probiotic honey supplementation compared with the control honey on metabolic profiles in patients with diabetic nephropathy
Public title
Effect of supplementation in treatment of patients with diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic nephropathy
Aged 40 to 80 years
Proteinuria level>0.3 g/24 h, with or without elevation of serum creatinine levels
Exclusion criteria:
History of active infection within 3 months
The intake of probiotic and/or synbiotic supplements within 3 months
Malignancy and/or liver cirrhosis
Age
From 45 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, after balanced blocked randomisation, all participants will have allocated into two treatment groups to take either probiotic honey or normal honey. Randomization will be done by the use of Stat Trek 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. Another person at the Akhavan Clinic in Kashan who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
IR.KAUMS.REC.1395.152
Health conditions studied
1
Description of health condition studied
Diabetic nephropathy
ICD-10 code
N08.3
ICD-10 code description
Glomerular disorders in diabetes mellitus (E10-E14 with common fourth character .2+)
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
4
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
7
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
8
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
9
Description
FPG
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
10
Description
LDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Control group: 25 g control honey (Sekkeh Gaz, Isfahan, Iran), once a day, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Intervention group: 25 g probiotic honey (Sekkeh Gaz, Isfahan, Iran), 108 Lactobacillus sporogenes CFU/g, once a day, for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavan Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Email
hamidi-gh@kaums.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, Kashan 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
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address
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
81151-87159
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
81151-87159
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
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