1. Home
  2. Approved trials
  3. » فارسی

The effects of a synbiotic food of fortified with beta-carotene on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with type 2 diabetes mellitus

View the latest revision

History
# Registration date Revision Id
2 2019-09-23, 1398/07/01 105025
1 2013-02-23, 1391/12/05 6035
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    Objective: The aim of this study is to determine the effects of a synbiotic food of fortified with beta-carotene on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with diabetic nephropathy. Study design: Randomized double-blinded cross-over controlled clinical trial. Inclusion Criteria: Patients with diabetic nephropathy with FPG ≥ 126 mg/dl, less than 15 years of their disease and aged 35 to 65 years will be included in this study. Exclusion Criteria: The use of substitute treatments including hormone or vitamin supplements, patients with chronic kidney disease, liver, lung and chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies, patients with low immune system ability (autoimmune) and pregnant or lactating women will be included in this study. Population and sample size: 70 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 the synbiotic food (intervention group: 35) or control food (control group: 35). Fasting blood samples will be taken at baseline and after 6-wk intervention. A 3-week washout period will be applied. Start and End Date of Intervention: 5 months (January 10, 2013-June 10, 2013). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, hs-CRP levels, plasma total antioxidant capacity (TAC) and total glutathione (GSH).
    empty
    هدف: هدف این مطالعه تعیین اثرات یک غذای سین بیوتیک غنی شده با بتاکاروتن بر روی پروفایل های متابولیک، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو در بیماران مبتلا به نفروپاتی دیابتیک است. طراحي انجام مطالعه: کارآزمایی بالینی تصادفي دو سوكور متقاطع. معیارهای ورود به مطالعه: بیماران مبتلا به نفروپاتی دیابتیک با FPG ≥ 126 mg/dl، کمتر از 15 سال از سابقه بیماری آن ها و در محدوده سنی 35 تا 65 سال وارد مطالعه خواهند شد. معیارهای خروج از مطالعه: استفاده از درمان های جايگزين از قبیل هورمون يا مكمل هاي ويتاميني، افراد مبتلا به بيماري مزمن كليوي، كبدي، ريوي و بيماري های مزمن يا حاد التهابي، بیماری دریچه قلب، سندروم روده کوتاه و آلرژی، افراد با نقص سیستم ایمنی (اتوایمیون) و زنان باردار و شیرده از مطالعه حذف خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 70 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 غذای سین بیوتیک (گروه مداخله: 35) یا غذای کنترل (گروه کنترل: 35) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله از بیماران گرفته خواهد شد. یک دوره Wash-out سه هفته ای بکار گرفته خواهد. زمان مداخله: 5 ماه (از 21 دی 1391 تا 21 خرداد 1392). پيامدها: گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین، hs-CRP، ظرفیت آنتی اکسیدانی توتال و گلوتاتیون توتال پلاسما در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
    empty
    empty
    Objective: The aim of this study is to determine the effects of a synbiotic food of fortified with beta-carotene on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with type 2 diabetes mellitus.
    empty
    هدف: هدف این مطالعه تعیین اثرات یک غذای سین بیوتیک غنی شده با بتاکاروتن بر روی پروفایل های متابولیک، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو در بیماران مبتلا به دیابت تیپ 2 است.
    empty
    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=25) or control (n=26).
    empty
    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 (25=n) یا کنترل (26=n) اختصاص داده خواهند شد.
    empty
    Among patients with type 2 diabetes mellitus referred to Naghavi outpatient Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 51 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.
    empty
    از بین بیماران مبتلا به دیابت تیپ 2 ارجاع شده به کلینیک سرپایی نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران، 51 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.
    empty
    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.
    empty
    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.
    empty
    Intervention group: Probiotic viable and heat-resistance strain Lactobacillus sporogenes (107 CFU), 0.1 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia, 0.05 g beta-carotene 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.
    empty
    گروه مداخله: پروبیوتیک زنده و مقاوم به حرارت سویه لاکتوباسیلوس اسپوروژنس (107 واحد)، 1/0 گرم اینولین، 38/0 گرم ایزومالت، 36/0 گرم سوربیتول، 05/0 گرم استویا، 05/0 گرم بتاکاروتن 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.
    empty
    Outcomes: Insulin (primary outcome), and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
    empty
    پيامدها: انسولین (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
    70
    51
    2013-01-10, 1391/10/21
    2013-02-12, 1391/11/24
    2013-06-11, 1392/03/21
    2013-02-15, 1391/11/27
    The effects of a synbiotic food of fortified with beta-carotene on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with diabetic nephropathy
    The effects of a synbiotic food of fortified with beta-carotene on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with type 2 diabetes mellitus
    اثرات یک غذای سین بیوتیک غنی شده با بتاکاروتن بر روی پروفایل های متابولیک، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو در بیماران مبتلا به نفروپاتی دیابتیک
    اثرات یک غذای سین بیوتیک غنی شده با بتاکاروتن بر روی پروفایل های متابولیک، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو در بیماران مبتلا به دیابت تیپ 2
    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
    زنان باردار
    استفاده از مکمل های ویتامین یا انسولین
    بیماری های التهابی و کبدی
    بیماری قلبی عروقی
    آلرژی
    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.
    empty
    Participants, investigators or the assessors of the outcomes are unaware of the study groups.
    empty
    شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
    empty
    empty

  • Primary outcomes

    #1
    FPG
    Insulin
    قند خون ناشتا
    انسولین
    Baseline and End-of-trial
    At the beginning of the study and after 6 weeks of intervention
    ابتدا و انتهای مداخله
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    Enzymatic
    Elisa
    آنزیمی
    الایزا
    #2
    Insulin
    empty
    انسولین
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Elisa
    empty
    الایزا
    empty
    #3
    hs-CRP
    empty
    hs-CRP
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Elisa
    empty
    الایزا
    empty
    #4
    Total Antioxidant Capacity
    empty
    ظرفیت آنتی اکسیدانی توتال
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #5
    Total Glutathione
    empty
    گلوتاتیون توتال
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty

  • Secondary outcomes

    #1
    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
    #2
    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
    #3
    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
    #4
    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
    #5
    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
    #6
    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
    #7
    empty
    Malondialdehyde
    empty
    مالون دی آلدئید
    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
    Nitric oxide
    empty
    نیتریک اکساید
    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
    #9
    empty
    Hs-CRP
    empty
    Hs-CRP
    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 kit
    empty
    کیت الایزا
    #10
    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
    #11
    empty
    Calcium
    empty
    کلسیم
    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
    #12
    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
    #13
    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
    #14
    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
    #15
    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
    #16
    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
    #17
    empty
    VLDL
    empty
    VLDL
    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 viable and heat-resistance strain Lactobacillus sporogenes (108 CFU), 0.2 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia, 0.05 g beta-carotene per 1 g, 20 g, thrice a day for 6 weeks
    Intervention group: Probiotic viable and heat-resistance strain Lactobacillus sporogenes (107 CFU), 0.1 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia, 0.05 g beta-carotene per 1 g, 9 g, thrice a day for 6 weeks.
    گروه مداخله: پروبیوتیک زنده و مقاوم به حرارت سویه لاکتوباسیلوس اسپوروژنس (108 واحد)، 2/0 گرم اینولین، 38/0 گرم ایزومالت، 36/0 گرم سوربیتول، 05/0 گرم استویا، 05/0 گرم بتاکاروتن به ازای هر گرم، 20 گرم، سه بار در روز برای 6 هفته
    گروه مداخله: پروبیوتیک زنده و مقاوم به حرارت سویه لاکتوباسیلوس اسپوروژنس (107 واحد)، 1/0 گرم اینولین، 38/0 گرم ایزومالت، 36/0 گرم سوربیتول، 05/0 گرم استویا، 05/0 گرم بتاکاروتن به ازای هر گرم، 9 گرم، سه بار در روز برای 6 هفته.
    #2
    Control group: 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 20 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.
    گروه کنترل: 38/0 گرم ایزومالت، 36/0 گرم سوربیتول، 05/0 گرم استویا به ازای هر گرم، 20 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.

  • 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: Naghavi outpatient Clinic
    Name of recruitment center - Persian: کلینیک سرپایی 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: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    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: 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
    Street address - English: Bolvare Ghotbe Ravandi, 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: Kashan University of Medical Science
    Name of organization / entity - Persian: 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: 8115187159
    Phone: +98 31 5546 3378
    Fax:
    Email: research@kaums.ac.ir
    Web page address:
    empty
    100
    empty
    Public
    empty
    Domestic
    empty
    Academic
    #2
    contact.organization_id:
    Name of organization / entity - English: Sekkeh Gaz Company
    Name of organization / entity - Persian: شرکت گز سکه
    Full name of responsible person - English: Sabiheh-Alsadat Alizadeh
    Full name of responsible person - Persian: صبیحه السادات علیزاده
    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
    Sekkeh Gaz Company
    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:
    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 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 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: Bolvare Ghotbe Ravandi, 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: 8719844189
    Phone: +98 36 1446 3378
    Mobile: +98 913 361 5446
    Fax: +98 36 1446 3377
    Email: asemi_r@yahoo.comasemi_z@kaums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD 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: 8719844189
    Phone: +98 31 55446 3378
    Mobile: +98 913 361 5446
    Fax: +98 31 5546 3378
    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 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: دکتری تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bolvare Ghotbe Ravandi, 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: 8719844189
    Phone: +98 36 1446 3378
    Mobile: +98 913 361 5446
    Fax: +98 36 1446 3377
    Email: asemi_r@yahoo.comasemi_z2kaums.as.ir
    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: 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: 8719844189
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax: +98 31 5546 3377
    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 a synbiotic food of fortified with beta-carotene on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with type 2 diabetes mellitus.
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=25) or control (n=26).
Settings and conduct
Among patients with type 2 diabetes mellitus referred to Naghavi outpatient Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 51 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.
Intervention groups
Intervention group: Probiotic viable and heat-resistance strain Lactobacillus sporogenes (107 CFU), 0.1 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia, 0.05 g beta-carotene 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: Insulin (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: IRCT201301195623N5
Registration date: 2013-02-23, 1391/12/05
Registration timing: retrospective

Last update: 2019-09-25, 1398/07/03
Update count: 1
Registration date
2013-02-23, 1391/12/05
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Science and Sekkeh Gaz company
Expected recruitment start date
2013-02-12, 1391/11/24
Expected recruitment end date
2013-02-15, 1391/11/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of a synbiotic food of fortified with beta-carotene on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with type 2 diabetes mellitus
Public title
The effects of a synbiotic food of fortified with beta-carotene in the treatment of diabetes
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
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: 51
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
Kashan University of Medical Science
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2013-02-11, 1391/11/23
Ethics committee reference number
29/5/1/4138/پ

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

Secondary outcomes

1

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

2

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

3

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

4

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

5

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

6

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

7

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

8

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

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

Description
VLDL
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), 0.1 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia, 0.05 g beta-carotene per 1 g, 9 g, thrice a day for 6 weeks.
Category
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
Naghavi outpatient Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
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
Kashan 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 Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8719844189
Phone
+98 31 55446 3378
Fax
+98 31 5546 3378
Email
asemi_r@yahoo.com
Web page address

Person responsible for updating data

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
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8719844189
Phone
+98 31 5546 3378
Fax
+98 31 5546 3377
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
Loading...