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Effects of synbiotic Gaz on fasting plasma glucose and lipid profiles of diabetic subjects

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History
# Registration date Revision Id
3 2019-09-24, 1398/07/02 104932
2 2012-02-12, 1390/11/23 6031
1
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  • Protocol summary

    Objective: The effect of probiotic Gaz enriched with inulin on the biochemical parameters including fasting plasma glucose, lipid profiles, inflammatory factors and stress oxidative in patients with type 2 diabetes. Study design: Randomized, cross-over double blind, control with normal Gaz. Inclusion criteria: Patients with diabetes type 2 with FBS ≥ 126 mg/dl and less than 15 years of their disease and in the aged 35 to 65 years were included. Exclusion criteria: Elective subjects with replace treatments including hormone or vitamin supplements, patients with chronic kidney disease, liver, lung and chronic or acute inflammatory disease, heart valve disease, short bowel syndrome and allergies, patients' with low immune system ability (autoimmune) and pregnant or lactating women, were excluded. population and sample size: 80 patients with type 2 diabetes among eligible people in Golabchi clinic in Kashan. Intervention: These patients were divided to two groups: intervention group (receive 20 g probiotic Gaz enriched with inulin) and normal group: (receive 20 g normal Gaz). After an overnight fasting, subjects referred for blood drawn. After this stage, blood samples tested. After 6 weeks of experiment, fasting blood samples were tested again. At the end stage, a 2-week wash-out period was designated. In the this stage, all subjects forbid from taking yoghurt or any other fermented food. Then, groups replace for consume 20 g probiotic Gaz enriched with inulin or 20 g Gaz normal for a 6- weeks. Start and end date of intervention: 14 weeks ( February 27, 2012- June 26, 2012). Baseline outcomes: Serum total cholesterol, LDL-cholesterol, HDL-cholesterol and TG, glucose, insulin, HOMA-IR score, hs-CRP, serum calcium, iron, zinc, Na, K, plasma TAC (total antioxidant capacity) and glutathione.
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    هدف: بررسی اثر گز پروبیوتیک غنی شده با اینولین بر روی پارامترهای بیوشیمیایی از قبیل گلوکز پلاسمایی، پروفایل های لیپیدی، فاکتورهای التهابی و استرس اکسیداتیو در بیماران مبتلا به دیابت نوع 2. طراحي انجام مطالعه: تصادفي، دو سوكور متقاطع، كنترل با گز معمولی. معیارهای ورود به مطالعه: بیماران مبتلا به دیابت نوع 2 با FBS ≥ 126 mg/dl، کمتر از 15 سال از سابقه بیماری و در محدوده سنی 35 تا 65 سال وارد مطالعه شدند. معیارهای خروج از مطالعه: افراد انتخابي با درمان های جايگزين از قبیل هورمون يا مكمل هاي ويتاميني، افراد مبتلا به بيماري های مزمن كليوي، كبدي، ريوي و بيماري های مزمن يا حاد التهابي، بیماری دریچه قلب، سندروم روده کوتاه و آلرژی، افراد با توانایی پایین سیستم ایمنی (اتوایمیون) و زنان باردار و شیرده حذف شدند. حجم نمونه و جمعیت مورد مطالعه: 80 بیمار مبتلا به دیابت نوع 2 در میان افراد واجد شرایط در درمانگاه گلابچی کاشان. مداخله مورد مطالعه: این بیماران به دو گروه: گروه مداخله (دریافت 20 گرم گز پروبیوتیک غنی شده با اینولین) و گروه کنترل (دریافت 20 گرم گز معمولی) تقسیم شدند. پس از یک شب ناشتایی، از افراد خونگیری شده و نمونه خون برای آزمایش فرستاده شد. پس از 6 هفته نمونه خون حالت ناشتا دوباره مورد آزمایش قرار گرفتند. در انتهای این مرحله، بیماران به مدت دو هفته تحت دوره wash-out قرار گرفتند. در طی این دوره، بیماران از مصرف فرآورده پروبیوتیکی و ماست پروبیوتیک منع می شوند. سپس، گروه ها برای دریافت روزانه 20 گرم گز پروبیوتیک غنی شده با اینولین و یا 20 گرم گز معمولی جابجا شدند. زمان مداخله: 14 هفته (از 27 اسفند 1390 تا 31 خرداد 1390). پيامد های اوليه مورد مطالعه: سطح سرمی کلسترول توتال،LDL - C ، HDL - C ، TG، گلوکز، انسولین، اندیس HOMA-IR، hs-CRP و کلسیم، آهن، روی، سدیم و پتاسیم سرم، توتال آنتی اکسیدان پلاسما و گلوتاتیون توتال.
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    Objective: The effect of probiotic Gaz enriched with inulin on the biochemical parameters including fasting plasma glucose, lipid profiles, inflammatory factors and stress oxidative in patients with type 2 diabetes.
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    هدف: بررسی اثر گز پروبیوتیک غنی شده با اینولین بر روی پارامترهای بیوشیمیایی از قبیل گلوکز پلاسمایی، پروفایل های لیپیدی، فاکتورهای التهابی و استرس اکسیداتیو در بیماران مبتلا به دیابت نوع 2.
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    Study design: Randomized cross-over double-blind controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive synbiotic (n=35) or control (n=35).
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    طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور متقاطع کنترل شده. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت سین بیوتیک (35=n) یا کنترل (35=n) اختصاص داده خواهند شد.
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    Among patients with type 2 diabetes mellitus referred to Gholabchi outpatient Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 70 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Synbiotic and control are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
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    از بین بیماران مبتلا به دیابت تیپ 2 ارجاع شده به کلینیک سرپایی گلابچی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران، 70 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. سین بیوتیک و کنترل از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 6 هفته.
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    Inclusion Criteria: Patients with type 2 diabetes mellitus aged 35 to 70 years. Exclusion Criteria: Pregnant, using insulin or vitamin supplements, liver and inflammatory diseases, coronary heart disease, allergies, short bowel syndrome.
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    معیارهای ورود به مطالعه: بیماران مبتلا به دیابت تیپ 2 در محدوده سنی 35 تا 70 سال. معیارهای خروج مطالعه: زنان باردار، استفاده از مکمل های ویتامین یا انسولین، بیماری های التهابی و کبدی، بیماری قلبی عروقی، آلرژی، سندروم روده کوتاه.
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    Intervention group: Probiotic viable and heat-resistance strain Lactobacillus sporogenes (107 CFU), 0.04 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks. Control group: 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks.
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    گروه مداخله: پروبیوتیک زنده و مقاوم به حرارت سویه لاکتوباسیلوس اسپوروژنس (107 واحد)، 04/0 گرم اینولین، 38/0 گرم ایزومالت، 36/0 گرم سوربیتول، 05/0 گرم استویا به ازای هر گرم، 9 گرم، سه بار در روز برای 6 هفته. گروه کنترل: 38/0 گرم ایزومالت، 36/0 گرم سوربیتول، 05/0 گرم استویا به ازای هر گرم، 9 گرم، سه بار در روز برای 6 هفته.
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    Outcomes: Inflammatory factor and calcium (primary outcome), and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
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    پيامدها: فاکتور التهابی و کلسیم (پیامدهای اولیه) و پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامد ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

    65
    70
    1
    1
    1
    80
    70
    2012-03-17, 1390/12/27
    2010-08-21, 1389/05/30
    2012-09-19, 1391/06/29
    2010-09-21, 1389/06/30
    Patients with type 2 diabetes mellitus aged 35 to 70 years
    بیماران مبتلا به دیابت تیپ 2 در محدوده سنی 35 تا 70 سال
    Pregnant
    Using insulin or vitamin supplements
    Liver and inflammatory diseases
    Coronary heart disease
    Allergies
    Short bowel syndrome
    زنان باردار
    استفاده از مکمل های ویتامین یا انسولین
    بیماری های التهابی و کبدی
    بیماری قلبی عروقی
    آلرژی
    سندروم روده کوتاه
    empty
    Randomization will be done by the use of computer-generated random numbers.
    empty
    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.
    empty
    empty

  • Primary outcomes

    #1
    Fasting glucose plasma
    Hs-CRP
    گلوکز پلاسما
    Hs-CRP
    The first and end intervention, before and after wash-out
    At the beginning of the study and after 6 weeks of intervention
    ابتدا و انتهای مداخله، قبل و بعد از دوره wash-out
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    enzymatic
    Elisa
    آنزیمی
    الایزا
    #2
    Insulin
    Calcium
    انسولین
    کلسیم
    The first and end intervention, before and after wash-out
    At the beginning of the study and after 6 weeks of intervention
    ابتدا و انتهای مداخله، قبل و بعد از دوره wash-out
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    Elisa
    Enzymatic kit
    الایزا
    کیت آنزیمی
    #3
    Total cholesterol
    empty
    کلسترول توتال
    empty
    The first and end intervention, before and after wash-out
    empty
    ابتدا و انتهای مداخله، قبل و بعد از دوره wash-out
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #4
    TG
    empty
    تری گلیسیرید
    empty
    The first and end intervention, before and after wash-out
    empty
    ابتدا و انتهای مداخله، قبل و بعد از دوره wash-out
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #5
    HDL-c
    empty
    HDL - C
    empty
    The first and end intervention, before and after wash-out
    empty
    ابتدا و انتهای مداخله، قبل و بعد از دوره wash-out
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #6
    hs-CRP
    empty
    hS - CRP
    empty
    The first and end intervention, before and after wash-out
    empty
    ابتدا و انتهای مداخله، قبل و بعد از دوره wash-out
    empty
    Elisa
    empty
    الایزا
    empty
    #7
    Total antioxidant
    empty
    توتال آنتی اکسیدان
    empty
    The first and end intervention, before and after wash-out
    empty
    ابتدا و انتهای مداخله، قبل و بعد از دوره wash-out
    empty
    spectrophotometer
    empty
    اسپکتروفتومتری
    empty
    #8
    Total glutathione
    empty
    گلوتاتیوت توتال
    empty
    The first and end intervention, before and after wash-out
    empty
    ابتدا و انتهای مداخله، قبل و بعد از دوره wash-out
    empty
    spectrophotometer
    empty
    اسپکتروفتومتری
    empty
    #9
    Serum calcium
    empty
    کلسیم سرم
    empty
    The first and end intervention, before and after wash-out
    empty
    ابتدا و انتهای مداخله، قبل و بعد از دوره wash-out
    empty
    Enzymatic
    empty
    آنزیمی
    empty

  • Secondary outcomes

    #1
    empty
    Insulin
    empty
    انسولین
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Elisa
    empty
    الایزا
    #2
    empty
    Insulin resistance
    empty
    مقاومت به انسولین
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Questionnaire
    empty
    پرسشنامه
    #3
    empty
    Triglycerides
    empty
    تری گلیسرید
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #4
    empty
    Total cholesterol
    empty
    کلسترول تام
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #5
    empty
    HDL
    empty
    HDL
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #6
    empty
    Total antioxidant
    empty
    توتال آنتی اکسیدانت
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #7
    empty
    Glutathione
    empty
    گلوتاتیون
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #8
    empty
    Liver enzymes
    empty
    آنزیم های کبدی
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #9
    empty
    Magnesium
    empty
    منیزیم
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #10
    empty
    Iron
    empty
    آهن
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #11
    empty
    Systolic blood pressure
    empty
    فشار خون سیستولیک
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Manometer
    empty
    مانومتر
    #12
    empty
    Diastolic blood pressure
    empty
    فشار خون دیاستولیک
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Manometer
    empty
    مانومتر
    #13
    empty
    LDL
    empty
    LDL
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #14
    empty
    Uric acid
    empty
    اسید اوریک
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #15
    empty
    Bilirubin
    empty
    بیلی روبین
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی

  • Intervention groups

    #1
    Intervention group: Probiotic Gaz contain of Lactobacillus Acidophilus and Bifidobacterium Bifidum with a total of min 1×107 colony-forming units+%3 Inulin, 10 g, twice a day, 6 weeks
    Intervention group: Probiotic viable and heat-resistance strain Lactobacillus sporogenes (107 CFU), 0.04 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks.
    گروه مداخله: گز پروبیوتیک حاوی لاکتوباسیلوس اسیدوفیلوس و بیفیدوباکتریوم بیفیدوم 107 به ازای هر گرم+ 3 درصد اینولین، 10 گرم، دو بار در روز بمدت 6 هفته
    گروه مداخله: پروبیوتیک زنده و مقاوم به حرارت سویه لاکتوباسیلوس اسپوروژنس (107 واحد)، 04/0 گرم اینولین، 38/0 گرم ایزومالت، 36/0 گرم سوربیتول، 05/0 گرم استویا به ازای هر گرم، 9 گرم، سه بار در روز برای 6 هفته.
    #2
    Control group: Normal Gaz, 10 g, twice a day, 6 weeks
    Control group: 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks.
    گروه کنترل: گز معمولی، 10 گرم، دو بار در روز بمدت 6 هفته
    گروه کنترل: 38/0 گرم ایزومالت، 36/0 گرم سوربیتول، 05/0 گرم استویا به ازای هر گرم، 9 گرم، سه بار در روز برای 6 هفته.

  • Recruitment centers

    #1
    Name of recruitment center - English: Golabchi Clinic, Kashan
    Name of recruitment center - Persian: کلینک گلابچی، کاشان
    Full name of responsible person - English: Faraji
    Full name of responsible person - Persian: فرجی
    Street address - English:
    Street address - Persian:
    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: Golabchi diabetes Clinic, Kashan
    Name of recruitment center - Persian: کلینک دیابت گلابچی، کاشان
    Full name of responsible person - English: Faraji
    Full name of responsible person - Persian: فرجی
    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: 8115187159
    Phone: +98 31 5546 3378
    Fax:
    Email: faraji-ma@kaums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Qom University Of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی قم
    Full name of responsible person - English: Dr Alireza Kohpeimaie
    Full name of responsible person - Persian: دکتر علیرضا کوه پیمایی
    Street address - English: Sahelli Bolvar
    Street address - Persian: بلوار ساحلی
    City - English: Qom
    City - Persian: قم
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Qom University Of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی قم
    Full name of responsible person - English: Dr Alireza Kohpeimaie
    Full name of responsible person - Persian: دکتر علیرضا کوه پیمایی
    Street address - English: Sahelli Bolvar
    Street address - Persian: بلوار ساحلی
    City - English: Qom
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3715614566
    Phone: +98 25 3784 2227
    Fax:
    Email: Kohpeimaie-a@qums.ac.ir
    Web page address:
    empty
    100
    empty
    Public
    empty
    Domestic
    empty
    Academic
    #2
    contact.organization_id:
    Name of organization / entity - English: gaz sekkeh
    Name of organization / entity - Persian: شرکت گز سکه
    Full name of responsible person - English: Dr goharian
    Full name of responsible person - Persian: دکتر گوهریان
    Street address - English: isfahan
    Street address - Persian: اصفهان
    City - English: isfahan
    City - Persian: اصفهان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    empty
    Yes
    empty
    empty
    empty
    gaz sekkeh
    empty
    شرکت گز سکه
    empty

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work:
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available:
    Country:
    Postal code:
    Phone:
    Mobile:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    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 Science
    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 Nutrition
    Position - Persian: دکترای تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan
    Street address - Persian: کاشان
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 36 1446 3378
    Mobile: 00
    Fax:
    Email: asemi_z@kaums.ac.ir, asemi_za@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University Of Medical Science
    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 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: Kashan
    Street address - Persian: کاشان
    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 36 1446 3378
    Mobile: 00
    Fax:
    Email: asemi_za@yahoo.com
    Web page address:

  • Person responsible for updating data

    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:
    Position - Persian:
    Latest degree:
    Area of specialty/work: 0
    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: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 36 1446 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir, asemi_za@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: Associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 36 1446 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_za@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 effect of probiotic Gaz enriched with inulin on the biochemical parameters including fasting plasma glucose, lipid profiles, inflammatory factors and stress oxidative in patients with type 2 diabetes.
Design
Study design: Randomized cross-over double-blind controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive synbiotic (n=35) or control (n=35).
Settings and conduct
Among patients with type 2 diabetes mellitus referred to Gholabchi outpatient Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 70 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Synbiotic and control are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with type 2 diabetes mellitus aged 35 to 70 years. Exclusion Criteria: Pregnant, using insulin or vitamin supplements, liver and inflammatory diseases, coronary heart disease, allergies, short bowel syndrome.
Intervention groups
Intervention group: Probiotic viable and heat-resistance strain Lactobacillus sporogenes (107 CFU), 0.04 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks. Control group: 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks.
Main outcome variables
Outcomes: Inflammatory factor and calcium (primary outcome), and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201201195623N1
Registration date: 2012-02-12, 1390/11/23
Registration timing: retrospective

Last update: 2019-09-24, 1398/07/02
Update count: 1
Registration date
2012-02-12, 1390/11/23
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
Qom University Of Medical Science and Sekkeh Gaz (Isfahan)
Expected recruitment start date
2010-08-21, 1389/05/30
Expected recruitment end date
2010-09-21, 1389/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of synbiotic Gaz on fasting plasma glucose and lipid profiles of diabetic subjects
Public title
Effects of probiotic Gaz enriched with Inolin in diabetes treat
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes mellitus aged 35 to 70 years
Exclusion criteria:
Pregnant Using insulin or vitamin supplements Liver and inflammatory diseases Coronary heart disease Allergies Short bowel syndrome
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
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
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qom University Of Medical Science
Street address
Sahelli Bolvar
City
Qom
Province
Ghoum
Postal code
3715614566
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
91288

Health conditions studied

1

Description of health condition studied
diabetes- cardiovascular
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Hs-CRP
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa

2

Description
Calcium
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

Secondary outcomes

1

Description
Insulin
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa

2

Description
Insulin resistance
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Questionnaire

3

Description
Triglycerides
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

4

Description
Total cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

5

Description
HDL
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

6

Description
Total antioxidant
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry

7

Description
Glutathione
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry

8

Description
Liver enzymes
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

9

Description
Magnesium
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

10

Description
Iron
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

11

Description
Systolic blood pressure
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Manometer

12

Description
Diastolic blood pressure
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Manometer

13

Description
LDL
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

14

Description
Uric acid
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

15

Description
Bilirubin
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

Intervention groups

1

Description
Intervention group: Probiotic viable and heat-resistance strain Lactobacillus sporogenes (107 CFU), 0.04 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks.
Category
Treatment - Other

2

Description
Control group: 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golabchi diabetes Clinic, Kashan
Full name of responsible person
Faraji
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
faraji-ma@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University Of Medical Science
Full name of responsible person
Dr Alireza Kohpeimaie
Street address
Sahelli Bolvar
City
Qom
Province
Ghoum
Postal code
3715614566
Phone
+98 25 3784 2227
Email
Kohpeimaie-a@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University Of Medical Science
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
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 Science
Full name of responsible person
Zatollah Asemi
Position
PhD Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 36 1446 3378
Fax
Email
asemi_za@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
Associate professor
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 36 1446 3378
Fax
Email
asemi_za@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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