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Clinical trial of the effect of probiotic supplementation compared with the placebo on cognitive function and metabolic profiles in patients with Alzheimer's disease

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History
# Registration date Revision Id
2 2019-09-16, 1398/06/25 104131
1 2015-12-01, 1394/09/10 6090
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of probiotic supplementation on metabolic profiles in patients with Alzheimer's disease. 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 Alzheimer's disease and aged 60 to 95 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with Alzheimer's disease of eligible and referred to Beheshti 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: 3 months. Outcomes: Metabolic profiles will be meseaured at study baseline and end-of-trial.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر پروفایل های متابولیک در بیماران مبتلا به بیماری آلزایمر 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 بیماری آلزایمر در محدوده سنی 60 تا 95 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به بیماری آلزایمر واجد شرایط و ارجاع شده به کلینیک بهشتی 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: 3 ماه. پيامدها: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    The aim of this study is to determine the effects of probiotic supplementation on cognitive function and metabolic profiles in patients with Alzheimer's disease.
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    هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر عملکرد شناختی و پروفایل های متابولیک در بیماران مبتلا به بیماری آلزایمر است.
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    Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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    تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی
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    60 patients with Alzheimer's disease of eligible at Golabchi (Kashan, Iran) and Sadeghyeh (Esfahan, Iran) Welfare Organizations in the study will be selected.
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    60 بیمار مبتلا به بیماری آلزایمر واجد شرایط در سازمان بهزیستی گلابچی (کاشان) و سازمان بهزیستی صادقیه (اصفهان) در مطالعه انتخاب خواهند شد.
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    Patients with Alzheimer's disease and aged 60 to 95 years will be included in this study. Patients with metabolic disorders, chronic infections and/or other clinically relevant disorders with exception of AD and consuming probiotic supplements within 6 weeks prior to the study, taking other forms of probiotics including probiotic yogurt, kefir, and other fermented foods will excluded.
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    بیماران مبتلا به بیماری آلزایمر در محدوده سنی 60 تا 95 سال وارد مطالعه خواهند شد. بیماران مبتلا به اختلالات متابولیک ، عفونتهای مزمن و / یا سایر اختلالات بالینی مرتبط و مصرف مکمل های پروبیوتیکی در طی 6 هفته قبل از مطالعه ، مصرف سایر اشکال پروبیوتیک ها از جمله ماست پروبیوتیک ، کفیر و سایر غذاهای تخمیر شده مستثنی هستند.
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    Patients will be assigned to receive either probiotic supplements (intervention group: n=30) and placebo (control group: n=30).
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    بیماران برای دریافت مکمل پروبیوتیک (گروه مداخله:30=n) و پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد.
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    Cognitive function and metabolic profiles
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    عملکرد شناختی و پروفایل های متابولیک

  • General information

    1
    1
    1
    Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in patients with Alzheimer's disease
    Clinical trial of the effect of probiotic supplementation compared with the placebo on cognitive function and metabolic profiles in patients with Alzheimer's disease
    کارآزمایی بالینی اثر مکمل یاری پروبیوتیک در مقایسه با پلاسبو بر پروفایل های متابولیک در بیماران مبتلا به بیماری آلزایمر
    کارآزمایی بالینی اثر مکمل یاری پروبیوتیک در مقایسه با پلاسبو بر عملکرد شناختی و پروفایل های متابولیک در بیماران مبتلا به بیماری آلزایمر
    Patients with Alzheimer's disease
    Aged 60 to 95 years
    بیماران مبتلا به بیماری آلزایمر
    محدوده سنی 60 تا 95 سال
    Patients with metabolic disorders
    Patients with chronic infections and/or other clinically relevant disorders
    Consuming probiotic supplements within 6 weeks prior to the study
    Taking other forms of probiotics including probiotic yogurt, kefir, and other fermented foods
    بیماران مبتلا به اختلالات متابولیک
    بیماران مبتلا به عفونتهای مزمن و / یا سایر اختلالات بالینی مرتبط
    مصرف مکمل های پروبیوتیکی در طی 6 هفته قبل از مطالعه
    مصرف سایر اشکال پروبیوتیک ها از جمله ماست پروبیوتیک ، کفیر و سایر غذاهای تخمیر شده
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    At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either probiotic supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
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    در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل پروبیوتیک- (n = 30) و پلاسبو (n = 30) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Welfare Organizations, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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    تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در سازمان های بهزیستی که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
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  • Primary outcomes

    #1
    Total antioxidant
    Cognitive function
    آنتی اکسیدانت توتال
    عملکرد شناختی
    Spectrophotometry
    Mini Mental State Exam (MMSE)
    اسپکتروفتومتری
    آزمون كوتاه وضعيت ذهني (MMSE)
    #2
    Glutathione
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    گلوتاتیون
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    At the beginning of the study and after 12 weeks of intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
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  • Secondary outcomes

    #1
    empty
    HDL-cholesterol
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    کلسترول HDL
    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
    #2
    empty
    LDL-cholesterol
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    کلسترول 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
    Enzymatic kit
    empty
    کیت آنزیمی
    #3
    empty
    Malondialdehyde
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    مالون دی آلدئید
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #4
    empty
    Glutathione
    empty
    گلوتاتیون
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #5
    empty
    Total antioxidant capacity
    empty
    ظرفیت آنتی اکسیدانی تام
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #6
    empty
    Fasting plasma glucose
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    گلوکز پلاسمایی ناشتا
    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
    Insulin resistance
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    مقاومت به انسولین
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    At the beginning of the study and after 12 weeks of intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Calculation using HOMA formula
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    محاسبه با استفاده از فرمول HOMA

  • Recruitment centers

    #1
    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:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Golabchi Welfare Organization
    Name of recruitment center - Persian: سازمان بهزیستی گلابچی
    Full name of responsible person - English: Reza Daneshvar
    Full name of responsible person - Persian: رضا دانشور
    Street address - English: Fine bozorg Ave, Kashan
    Street address - Persian: کاشان، خیابان فین بزرگ
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 31 5530 9223
    Fax:
    Email: redaneshvar@gmail.com
    Web page address:
    #2
    Name of recruitment center - English: Sadeghyeh Welfare Organizations
    Name of recruitment center - Persian: سازمان بهزیستی صادقیه
    Full name of responsible person - English: Reza Daneshvar
    Full name of responsible person - Persian: رضا دانشور
    Street address - English: Aminabad, Isfahan
    Street address - Persian: اصفهان، امین آباد
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8168663921
    Phone: +98 31 3380 6558
    Fax:
    Email: redaneshvar@gmail.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:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Gholamali Hamidi
    Full name of responsible person - Persian: غلامعلی حمیدی
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5557 8010
    Fax:
    Email: research@kaums.ac.ir
    Web page address:
    empty
    Public
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    Domestic
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    Academic
    Vice chancellor for research, Kashan University of Medical Sciences
    Kashan University of Medical Sciences
    معاونت پژوهشی دانشگاه علوم پزشکی کاشان
    دانشگاه علوم پزشکی کاشان

  • 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: Nutritionist
    Position - Persian: متخصص تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5562 0608
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکتری تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکتری تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    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:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکتری تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
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    Undecided - It is not yet known if there will be a plan to make this available
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    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست

Protocol summary

Study aim
The aim of this study is to determine the effects of probiotic supplementation on cognitive function and metabolic profiles in patients with Alzheimer's disease.
Design
Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Settings and conduct
60 patients with Alzheimer's disease of eligible at Golabchi (Kashan, Iran) and Sadeghyeh (Esfahan, Iran) Welfare Organizations in the study will be selected.
Participants/Inclusion and exclusion criteria
Patients with Alzheimer's disease and aged 60 to 95 years will be included in this study. Patients with metabolic disorders, chronic infections and/or other clinically relevant disorders with exception of AD and consuming probiotic supplements within 6 weeks prior to the study, taking other forms of probiotics including probiotic yogurt, kefir, and other fermented foods will excluded.
Intervention groups
Patients will be assigned to receive either probiotic supplements (intervention group: n=30) and placebo (control group: n=30).
Main outcome variables
Cognitive function and metabolic profiles

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201511305623N60
Registration date: 2015-12-01, 1394/09/10
Registration timing: retrospective

Last update: 2019-09-18, 1398/06/27
Update count: 1
Registration date
2015-12-01, 1394/09/10
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 Sciences
Expected recruitment start date
2015-10-24, 1394/08/02
Expected recruitment end date
2015-11-01, 1394/08/10
Actual recruitment start date
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Actual recruitment end date
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Trial completion date
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Scientific title
Clinical trial of the effect of probiotic supplementation compared with the placebo on cognitive function and metabolic profiles in patients with Alzheimer's disease
Public title
Effect of supplementation in treatment of patients with Alzheimer's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Alzheimer's disease Aged 60 to 95 years
Exclusion criteria:
Patients with metabolic disorders Patients with chronic infections and/or other clinically relevant disorders Consuming probiotic supplements within 6 weeks prior to the study Taking other forms of probiotics including probiotic yogurt, kefir, and other fermented foods
Age
From 60 years old to 95 years old
Gender
Both
Phase
2
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 take either probiotic supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Welfare Organizations, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2015-10-24, 1394/08/02
Ethics committee reference number
IR.Kaums.REC.1394.97

Health conditions studied

1

Description of health condition studied
Alzheimer's disease
ICD-10 code
F00
ICD-10 code description
Dementia in Alzheimer disease

Primary outcomes

1

Description
Cognitive function
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Mini Mental State Exam (MMSE)

Secondary outcomes

1

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

2

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

3

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

4

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

5

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

6

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

7

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

8

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

9

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

10

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

11

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

12

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

Intervention groups

1

Description
Intervention group: Probiotic supplements containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/g) and Lactobacillus fermentum (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
Golabchi Welfare Organization
Full name of responsible person
Reza Daneshvar
Street address
Fine bozorg Ave, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5530 9223
Email
redaneshvar@gmail.com

2

Recruitment center
Name of recruitment center
Sadeghyeh Welfare Organizations
Full name of responsible person
Reza Daneshvar
Street address
Aminabad, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8168663921
Phone
+98 31 3380 6558
Email
redaneshvar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5557 8010
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 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
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5562 0608
Email
asemi_r@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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