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The effect of probiotic supplementation on lipid profile, markers of insulin metabolism, biomarkers of inflammation and oxidative stress factors in patients with diabetes nephropathy

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History
# Registration date Revision Id
2 2019-09-23, 1398/07/01 104746
1 2017-06-21, 1396/03/31 26325
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of probiotics supplementation on lipid profile, markers of insulin metabolism, biomarkers of inflammation and oxidative stress factors in patients with diabetes 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 70 years will be included in this study.Exclusion criteria:change in type and dosage of insulin and lowering drugs of Blood glucose.taking probiotic supplements and other forms of probiotics including probiotic yogurt.taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids,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 supplements (intervention group: n=30) and placebo (control group: n=30).Fasting blood samples will be taken at baseline and after 12-wk intervention.Start and end date of intervention: 12 weeks.Outcomes: Insulin metabolism parameters (primary outcomes) and lipid profiles,biomarkers of inflammation and oxidative stress factors (secondry outcomes) will be quantified at study baseline and end-of-trial.
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    هدف:هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر پروفایل لیپیدی، مارکر های متابولیسم انسولین،بیومارکر های التهابی و فاکتور های استرس اکسیداتیو در بیماران مبتلا به نفروپاتی دیابتی 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 دیابتی در محدوده سنی 40 تا 70سال؛معیار خروج از مطالعه:تغییر در دوز و نوع انسولین و داروهای پایین آورنده قند خون،گرفتن مکمل پروبیوتیک و سایر فرم های پروبیوتیک از قبیل ماست پروبیوتیک،گرفتن مکمل آنتی اکسیدانت و ضد التهابی از قبیل ویتامین E، ویتامین C و اسیدهای چرب امگا-3، عدم تمایل به همکاری از مطالعه خارج خواهند شد.حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به نفروپاتی دیابتی 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 مکمل پروبیوتیک (گروه مداخله:30=n) و پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته.پيامدها: مارکر های متابولیسم انسولین(پیامدهای اولیه)، پروفایل لیپید یبیومارکر های التهابی و فاکتور های استرس اکسیداتیو (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 probiotics supplementation on lipid profile, markers of insulin metabolism, biomarkers of inflammation and oxidative stress factors in patients with diabetes nephropathy.
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    هدف:هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر پروفایل لیپیدی، مارکر های متابولیسم انسولین،بیومارکر های التهابی و فاکتور های استرس اکسیداتیو در بیماران مبتلا به نفروپاتی دیابتی است.
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    Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive probiotic (n=30) or placebo (n=30). Probiotic and placebos capsules are similar in shape and size.
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    طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت پروبیوتیک (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های پروبیوتیک و پلاسبو از نظر شکل و اندازه مشابه هستند.
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    Among patients with diabetic nephropathy referred to Shahid Beheshti Hospital affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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    از بین بیماران مبتلا به نفروپاتی دیابتیک ارجاع شده به بیمارستان شهید بهشتی به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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    Inclusion criteria: Patients with diabetic nephropathy and aged 45 to 85 years will be included in this study.Exclusion criteria:History of active infection within 3 months, intake of probiotic and/or synbiotic supplements within 3 months, history of hospital admission within 3 months, malignancy and/or liver cirrhosis.
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    معیار ورود به مطالعه: بیماران مبتلا به نفروپاتی دیابتی در محدوده سنی 45 تا 85 سال. معیار خروج از مطالعه:سابقه عفونت فعال در طی سه ماه قبل، دریافت مکمل پروبیوتیک و/یا سین بیوتیک در طی سه ماه قبل، سابقه بستری شدن بیمارستان در طی سه ماه قبل، بدخیمی و/یا سیروز کبدی.
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    Intervention group: Probiotic supplements containing four strains of Lactobacillus acidophilus (2×109 CFU/g),Lactobacillus fermentum (2×109 CFU/g),Bifidobacterium bifidum (2×109 CFU/g),Lactobacillus reuteri (2×109 CFU/g), daily, for 12 weeks orally. Control group: Placebo, daily, for 12 weeks orally.
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    گروه مداخله: مکمل پروبیوتیک حاوی 4 سویه لاکتوباسیلوس اسیدوفیلوس (109× 2 واحد به ازای هر گرم)، لاکتوباسیلوس فرمنتوم (109×2 واحد به ازای هر گرم)، بیفیدوباکتریوم بیفیدوم (109×2 واحد به ازای هر گرم)، لاکتوباسیلوس روتری ( 109×2 واحد به ازای هر گرم)، روزانه، به صورت خوراکی برای 12 هفته. گروه کنترل: پلاسبو، روزانه، به صورت خوراکی برای 12 هفته.
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    Outcomes: Insulin metabolism parameters (primary outcomes) and lipid profiles,biomarkers of inflammation and oxidative stress factors (secondry outcomes) will be quantified at study baseline and end-of-trial.
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    پيامدها: مارکر های متابولیسم انسولین(پیامدهای اولیه)، پروفایل لیپید یبیومارکر های التهابی و فاکتور های استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

    40
    45
    70
    85
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    1
    1
    2
    3
    Patients with diabetic nephropathy aged 45 to 85 years
    بیماران مبتلا به نفروپاتی دیابتی در محدوده سنی 45 تا 85 سال
    History of active infection within 3 months
    Intake of probioticand/or synbiotic supplements within 3 months
    History of hospitaladmission within 3 months
    Malignancy and/or liver cirrhosis
    سابقه عفونت فعال در طی سه ماه قبل
    دریافت مکمل پروبیوتیک و/یا سین بیوتیک در طی سه ماه قبل
    سابقه بستری شدن بیمارستان در طی سه ماه قبل
    بدخیمی و/یا سیروز کبدی
    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.
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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 receive supplement or placebo. 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 برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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    شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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  • Primary outcomes

    #1
    Insulin
    Insulin resistance
    انسولین
    مقاومت به انسولین
    Elisa kit
    Calculation using HOMA formula
    کیت الایزا
    با استفاده از فرمول HOMA
    #2
    Insulin resistance
    empty
    مقاومت به انسولین
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Calculation using HOMA formula
    empty
    با استفاده از فرمول HOMA
    empty

  • Secondary outcomes

    #1
    اسکتروفتومتری
    اسپکتروفتومتری
    #2
    اسکتروفتومتری
    اسپکتروفتومتری
    #3
    اسکتروفتومتری
    اسپکتروفتومتری
    #4
    اسکتروفتومتری
    اسپکتروفتومتری
    #5
    empty
    HbA1c
    empty
    هموگلوبین A1c
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #6
    empty
    Serum Creatinine
    empty
    کراتینین سرمی
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #7
    empty
    Blood Urea Nitrogen
    empty
    نیتروژن اوره خون
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #8
    empty
    urine protein
    empty
    پروتئین ادراری
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #9
    empty
    Expressed levels of PPAR-γ gene
    empty
    سطوح بیان ژن PPAR-γ
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Real-time PCR
    empty
    Real-time PCR
    #10
    empty
    Expressed levels of LDL receptor gene
    empty
    سطوح بیان ژن گیرنده LDL
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Real-time PCR
    empty
    Real-time PCR
    #11
    empty
    Expressed levels of interleukin-1gene
    empty
    سطوح بیان ژن اینترلوکین 1
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Real-time PCR
    empty
    Real-time PCR
    #12
    empty
    Expressed levels of TNF-a gene
    empty
    سطوح بیان ژن TNF-a
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Real-time PCR
    empty
    Real-time PCR
    #13
    empty
    Expressed levels of TGF-B gene
    empty
    سطوح بیان ژن TGF-B
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Real-time PCR
    empty
    Real-time PCR
    #14
    empty
    advanced glycosylation end-products
    empty
    اندازه گیری فرآورده های نهایی گلیکوزیلاسیون
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Fluorometric method
    empty
    روش فلوریمتری
    #15
    empty
    Serum insulin
    empty
    انسولین سرم
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت الایزا

  • Intervention groups

    #1
    Intervention group: Probiotic supplements containing five strains of Lactobacillus acidophilus (2×109 CFU/g),Lactobacillus fermentum (2×109 CFU/g),Bifidobacterium bifidum (2×109 CFU/g),Lactobacillus reuteri (2×109 CFU/g),Lactobacillus casei (2×109 CFU/g) daily, for 12 weeks orally.
    Intervention group: Probiotic supplements containing four strains of Lactobacillus acidophilus (2×109 CFU/g),Lactobacillus fermentum (2×109 CFU/g),Bifidobacterium bifidum (2×109 CFU/g),Lactobacillus reuteri (2×109 CFU/g), daily, for 12 weeks orally.
    گروه مداخله: مکمل پروبیوتیک حاوی 5 سویه لاکتوباسیلوس اسیدوفیلوس (109× 2 واحد به ازای هر گرم)، لاکتوباسیلوس فرمنتوم(109×2 واحد به ازای هر گرم)، بیفیدوباکتریوم بیفیدوم(109×2 واحد به ازای هر گرم)، لاکتوباسیلوس روتری( 109×2 واحد به ازای هر گرم)، لاکتوباسیلوس کازایی(109×2 واحد به ازای هر گرم) روزانه، به صورت خوراکی برای 12 هفته
    گروه مداخله: مکمل پروبیوتیک حاوی 4 سویه لاکتوباسیلوس اسیدوفیلوس (109× 2 واحد به ازای هر گرم)، لاکتوباسیلوس فرمنتوم (109×2 واحد به ازای هر گرم)، بیفیدوباکتریوم بیفیدوم (109×2 واحد به ازای هر گرم)، لاکتوباسیلوس روتری ( 109×2 واحد به ازای هر گرم)، روزانه، به صورت خوراکی برای 12 هفته.

  • 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: Shahid Beheshti Clinic
    Name of recruitment center - Persian: کلینیک شهید بهشتی
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    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: 88715973474
    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: 88715973474
    Phone: +98 31 5546 3378
    Fax:
    Email: research@kaums.ac.ir
    Web page address:
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    Public
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    Domestic
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    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: 88715973474
    Phone: +98 31 5546 3378
    Mobile: 00
    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: 88715973474
    Phone: +98 31 5546 3378
    Mobile: 00
    Fax:
    Email: 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: 88715973474
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    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.

Protocol summary

Study aim
Objective: The aim of this study is to determine the effects of probiotics supplementation on lipid profile, markers of insulin metabolism, biomarkers of inflammation and oxidative stress factors in patients with diabetes nephropathy.
Design
Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive probiotic (n=30) or placebo (n=30). Probiotic and placebos capsules are similar in shape and size.
Settings and conduct
Among patients with diabetic nephropathy referred to Shahid Beheshti Hospital affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with diabetic nephropathy and aged 45 to 85 years will be included in this study.Exclusion criteria:History of active infection within 3 months, intake of probiotic and/or synbiotic supplements within 3 months, history of hospital admission within 3 months, malignancy and/or liver cirrhosis.
Intervention groups
Intervention group: Probiotic supplements containing four strains of Lactobacillus acidophilus (2×109 CFU/g),Lactobacillus fermentum (2×109 CFU/g),Bifidobacterium bifidum (2×109 CFU/g),Lactobacillus reuteri (2×109 CFU/g), daily, for 12 weeks orally. Control group: Placebo, daily, for 12 weeks orally.
Main outcome variables
Outcomes: Insulin metabolism parameters (primary outcomes) and lipid profiles,biomarkers of inflammation and oxidative stress factors (secondry outcomes) will be quantified at study baseline and end-of-trial.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2017061134458N1
Registration date: 2017-06-21, 1396/03/31
Registration timing: retrospective

Last update: 2019-09-23, 1398/07/01
Update count: 1
Registration date
2017-06-21, 1396/03/31
Registrant information
Name
Alireza Mafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7052
Email address
armafi@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-05-15, 1396/02/25
Expected recruitment end date
2017-06-15, 1396/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic supplementation on lipid profile, markers of insulin metabolism, biomarkers of inflammation and oxidative stress factors in patients with diabetes 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 45 to 85 years
Exclusion criteria:
History of active infection within 3 months Intake of probioticand/or synbiotic supplements within 3 months History of hospitaladmission 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
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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
88715973474
Approval date
2017-04-30, 1396/02/10
Ethics committee reference number
IR.Kaums.REC.1396.43

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 resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula

Secondary outcomes

1

Description
Triglyceride
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

2

Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

3

Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

4

Description
hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

5

Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

6

Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

7

Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

8

Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

9

Description
HbA1c
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

10

Description
Serum Creatinine
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

11

Description
Blood Urea Nitrogen
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

12

Description
urine protein
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

13

Description
Expressed levels of PPAR-γ gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Real-time PCR

14

Description
Expressed levels of LDL receptor gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Real-time PCR

15

Description
Expressed levels of interleukin-1gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Real-time PCR

16

Description
Expressed levels of TNF-a gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Real-time PCR

17

Description
Expressed levels of TGF-B gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Real-time PCR

18

Description
advanced glycosylation end-products
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Fluorometric method

19

Description
Serum insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

Intervention groups

1

Description
Intervention group: Probiotic supplements containing four strains of Lactobacillus acidophilus (2×109 CFU/g),Lactobacillus fermentum (2×109 CFU/g),Bifidobacterium bifidum (2×109 CFU/g),Lactobacillus reuteri (2×109 CFU/g), daily, for 12 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo, daily, for 12 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Clinic
Full name of responsible person
Zatollah Asemi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
kashan
Province
Isfehan
Postal code
88715973474
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
88715973474
Phone
+98 31 5546 3378
Email
research@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
88715973474
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
88715973474
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
88715973474
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
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