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Effect of Morus Alba leaves’s extract supplement on blood glucose, lipid profiles, HbA1c, insulin resistance ,inflammation factors and oxidative stress biomarkers in patients with type 2 diabetes

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History
# Registration date Revision Id
3 2022-04-03, 1401/01/14 224329
2 2021-12-04, 1400/09/13 208112
1 2017-01-12, 1395/10/23 12509
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of Morus Alba leaves’ extract supplement on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with diabetes type 2. Study design: Randomized double-blinded controlled clinical trial. Inclusion Criteria: Patients with diabetes type 2 with FPG ≥ 126 mg/dl, less than 15 years of their disease and aged 35 to75 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: 90 patients with diabetes type 2 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 capsule300 mg Morus Alba leaves’ extract supplement (intervention group), or placebo(control group). Fasting blood samples will be taken at baseline and after12-wk intervention. Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, lipid profile, hs-CRP levels, plasma total antioxidant capacity (TAC) and total glutathione (GSH).
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    هدف: هدف این مطالعه تعیین اثرات برگ توت سفید بر روی پروفایل های متابولیک، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو در بیماران مبتلا به دیابت تیپ 2 است. طراحي انجام مطالعه: کارآزمایی بالینی تصادفي دو سوكور. معیارهای ورود به مطالعه: بیماران مبتلا به دیابت تیپ 2 با FPG ≥ 126 mg/dl، کمتر از 15 سال از سابقه بیماری آن ها و در محدوده سنی 35 تا 75 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 دیابت تیپ 2 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 کپسول 300 میلیگرمی عصاره برگ توت (گروه مداخله)، یا پلاسبو (گروه کنترل) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 12هفته بعد از مداخله از بیماران گرفته خواهد شد. پيامدها: گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین،پروفایل لیپیدی، hs-CRP، ظرفیت آنتی اکسیدانی توتال و گلوتاتیون توتال پلاسما در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    The aim of this study is to determine the effects of Mulbery alba leave extract on the metabolic profile, inflammatory factors, and biomarkers of oxidative stress and ALT and AST enzymes on patients with TDM2.
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    هدف این مطالعه تعیین اثرات برگ توت سفید بر روی پروفایل های متابولیک، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو و آنزیم های ALT و AST در بیماران مبتلا به دیابت تیپ 2 است.
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    A randomized, double-blind, controlled clinical trial on 60 patients. Computer-generated random numbers were utilized for random assignment.
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    کارآزمایی بالینی دارای گروه کنترل، دو سویه کور ، تصادفی شده، بر روی 60 بیمار. برای تصادفی سازی از اعداد تصادفی تولید شده با کامپیوتر استفاده شد.
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    60 eligible patients with type 2 diabetes and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Patients will be given 300 mg capsule of mulberry leaf extract twice a day (intervention group) or placebo (control group). Fasting blood samples will be taken from patients at the beginning of the study and 12 weeks after the intervention. Then, variables including fasting plasma glucose, serum insulin, HOMA-IR, lipid profile, QUICKI, CRP, NO, total antioxidant capacity, total plasma glutathione, MDA, hemoglobin A1C, and ALT and AST enzymes Will be measured.
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    بیمار مبتلا به دیابت تیپ 2 واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. بیماران برای دریافت کپسول 300 میلیگرمی عصاره برگ توت دو بار در روز (گروه مداخله)، یا پلاسبو (گروه کنترل) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 12هفته بعد از مداخله از بیماران گرفته خواهد شد. سپس متغیر های گلوکز پلاسمایی ناشتا، انسولین سرمی، HOMA-IR، پروفایل لیپیدی، CRP ،QUICKI NO، ظرفیت آنتی اکسیدانی توتال، گلوتاتیون توتال پلاسما،MDA، هموگلوبین A1C و آنزیمهای ALT و AST در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    Taking berry extract in the last three months; Changes in glucose-lowering drugs during the study; Taking anticoagulants; Pregnancy or lactation; Malignancies; Chronic liver disease.
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    مصرف عصاره توت در سه ماه گذشته؛ تغییر در داروهای کاهش دهنده گلوکز در طول مطالعه؛ مصرف داروهای ضد انعقاد؛ بارداری یا شیردهی؛ بدخیمی ها؛ بیماری های مزمن کبدی.
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    The intervention consists of taking mulberry extract supplement (300 mg) twice per a day during 12 weeks, which is prepared by the Pharmaceutical Company of Barij Essence in Kashan, Iran, previously confirmed by the Food and Drug Administration. The placebo capsules contains starch produced by the same company.
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    مداخله شامل مصرف مکمل عصاره توت (300 میلی گرم) دو بار در روز به مدت 12 هفته است که توسط شرکت داروسازی باریج اسانس در کاشان تهیه شده است که قبلاً توسط سازمان غذا و دارو تایید شده بود. کپسول پلاسبو شامل نشاسته است که توسط همان شرکت تولید می گردد.
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    Fasting plasma glucose; serum insulin; HOMA-IR; lipid profile; QUICKI; CRP; NO; total antioxidant capacity; total plasma glutathione; MDA; hemoglobin A1C
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    گلوکز پلاسمایی ناشتا؛ انسولین سرمی؛ HOMA-IR؛ QUICKI؛ پروفایل لیپیدی؛ CRP؛ NO؛ ظرفیت آنتی اکسیدانی توتال؛ گلوتاتیون توتال پلاسما؛ MDA؛ هموگلوبین A1C

  • General information

    75
    70
    1
    1
    1
    70
    60
    2017-11-22, 1396/09/01
    2017-05-22, 1396/03/01
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    Due to alterations appeared during the trial.
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    به علت تغییرات ایجاد شده در حین مطالعه.
    T2DM patients with FPG of more than 126 mg/dL and less than 200 mg/dL.
    بیماران T2DM با FPG بیش از 126 میلی گرم در دسی لیتر و کمتر از 200 میلی گرم در دسی لیتر.
    Mulberry extract intake in the last three months.
    Changing in glucose-lowering medications.
    Taking anticoagulants during the study.
    Pregnancy or lactating.
    Malignancies.
    Chronic hepatic diseases.
    مصرف عصاره توت در سه ماه گذشته
    تغییر در داروهای کاهش دهنده گلوکز در طول مطالعه
    مصرف داروهای ضد انعقاد
    بارداری یا شیردهی
    بدخیمی ها
    بیماری های مزمن کبدی
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    Computer-generated random numbers will be utilized for random assignment. Clinic-trained personnel will be performed all participant enrollment, random allocation and group assignment.
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    برای تخصیص تصادفی از اعداد تصادفی تولید شده توسط کامپیوتر استفاده خواهد شد. پرسنل آموزش دیده در کلینیک ثبت نام شرکت کنندگان، تخصیص تصادفی و تخصیص گروهی را انجام خواهند داد.
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    Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person 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 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
    Fasting plasma glucose
    HOMA-IR
    قند خون ناشتا
    شاخص مقاومت به انسولین
    Baseline and End-of-trial
    Before the beginning of the study and 12 weeks after
    ابتدا و انتهای مداخله
    ابتدا و 12 هفته بعد از مداخله
    #2
    Insulin
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    انسولین
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    Baseline and End-of-trial
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    ابتدا و انتهای مداخله
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    Elisa
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    الایزا
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    #3
    Hs-CRP
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    پروتئین واکنشگر C با حساسیت بالا
    empty
    Baseline and End-of-trial
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    ابتدا و انتهای مداخله
    empty
    Elisa
    empty
    الایزا
    empty
    #4
    lipid profile
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    پروفایل لیپیدی
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    Baseline and End-of-trial
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    ابتدا و انتهای مداخله
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    blood test
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    آزمایش خون
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    #5
    Total Antioxidant Capacity
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    ظرفیت توتال آنتی اکسیدان
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    Baseline and End-of-trial
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    ابتدا و انتهای مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
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    #6
    Total glutathione
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    توتال گلوتاتیون
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    Baseline and End-of-trial
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    ابتدا و انتهای مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
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  • Secondary outcomes

    #1
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    Fasting plasma glucose (FPG)
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    قند خون ناشتا
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    Before the beginning of the study and after 12 weeks.
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    قبل از شروع مداخله و 12 هفته بعد.
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    ELISA
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    الایزا
    #2
    empty
    Insulin
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    انسولین
    empty
    Before the beginning of the study and after 12 weeks.
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    قبل از شروع مداخله و 12 هفته بعد.
    empty
    ELISA
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    الایزا
    #3
    empty
    QUICKI
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    شاخص حساسیت به انسولین
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    Before the beginning of the study and after 12 weeks.
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    قبل از شروع مداخله و 12 هفته بعد.
    empty
    ELISA
    empty
    الایزا
    #4
    empty
    HbA1C
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    هموگلوبین A1C
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    Before the beginning of the study and after 12 weeks.
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    قبل از شروع مداخله و 12 هفته بعد.
    empty
    ELISA
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    الایزا
    #5
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    Triglyceride
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    تری گلیسیرید
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    Before the beginning of the study and after 12 weeks.
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    قبل از شروع مداخله و 12 هفته بعد.
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    Enzymatic
    empty
    آنزیمی
    #6
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    Very low density lipoptotein (VLDL)-Cholesterol
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    کلسترول-لیپوپروتئین با پگالی خیلی پائین
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    Before the beginning of the study and after 12 weeks.
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    قبل از شروع مداخله و 12 هفته بعد.
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    Enzymatic
    empty
    آنزیمی
    #7
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    Cholesterol
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    کلسترول
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    Before the beginning of the study and after 12 weeks.
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    قبل از شروع مداخله و 12 هفته بعد.
    empty
    Enzymatic
    empty
    آنزیمی
    #8
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    Low density lipoptotein (LDL)-Cholesterol
    empty
    کلسترول- لیپوپروتئین با چگالی پائین
    empty
    Before the beginning of the study and after 12 weeks.
    empty
    قبل از شروع مداخله و 12 هفته بعد.
    empty
    Enzymatic
    empty
    آنزیمی
    #9
    empty
    High density lipoptotein (HDL)-Cholesterol
    empty
    کلسترول-لیپوپروتئین با چگالی بالا
    empty
    Before the beginning of the study and after 12 weeks.
    empty
    قبل از شروع مداخله و 12 هفته بعد.
    empty
    Enzymatic
    empty
    آنزیمی
    #10
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    Alanine transaminase (ALT)
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    ALT
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    Before the beginning of the study and after 12 weeks.
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    قبل از شروع مداخله و 12 هفته بعد.
    empty
    Enzymatic
    empty
    آنزیمی
    #11
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    Aspartate transaminase (AST)
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    AST
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    Before the beginning of the study and after 12 weeks.
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    قبل از شروع مداخله و 12 هفته بعد.
    empty
    Enzymatic
    empty
    آنزیمی
    #12
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    C reactive protein (CRP)
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    پروتئین واکنش گر C
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    Before the beginning of the study and after 12 weeks.
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    قبل از شروع مداخله و 12 هفته بعد.
    empty
    Enzymatic
    empty
    آنزیمی
    #13
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    Nitric oxide (NO)
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    نیتریک اکساید
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    Before the beginning of the study and after 12 weeks.
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    قبل از شروع مداخله و 12 هفته بعد.
    empty
    Spectrophotometry
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    اسپکتروفتومتری
    #14
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    Total antioxidant capacity (TAC)
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    ظرفیت تام آنتی اکسیدانی
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    Before the beginning of the study and after 12 weeks.
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    قبل از شروع مداخله و 12 هفته بعد.
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #15
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    Glutathione (GSH)
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    گلوتاتیون
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    Before the beginning of the study and after 12 weeks.
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    قبل از شروع مداخله و 12 هفته بعد.
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #16
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    Malondialdehyde (MDA)
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    مالون دی آلدهید
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    Before the beginning of the study and after 12 weeks.
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    قبل از شروع مداخله و 12 هفته بعد.
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    Spectrophotometry
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    اسپکتروفتومتری

  • Intervention groups

    #1
    Intervention group:300 mg Morus Alba leaves’s extract capsule, 2 times a day for 12 weeks
    Intervention group:300 mg Morus Alba leaves’s extract capsule, 2 times a day; 12 weeks; produced by Barij esans Co, Kashan, Iran.
    گروه مداخله:روزانه دو عدد کپسول 300 میلیگرمی عصاره برگ توت،12 هفته
    گروه مداخله:روزانه دو عدد کپسول 300 میلیگرمی عصاره برگ توت؛ 12 هفته؛ ساخت شرکت باریج اسانس، کاشان، ایران.
    #2
    control group:300 mg placebo capsule, 2 times a day for 12 weeks
    Control group: placebo capsule; 2 times a day; 12 weeks; produced by Barij esans Co, Kashan, Iran.
    گروه کنترل:روزانه دو عدد کپسول 300 میلیگرمی پلاسبو،12 هفته
    گروه کنترل:روزانه دو عدد کپسول پلاسبو؛ ترکیب نشاسته؛ 12 هفته؛ ساخت شرکت باریج اسانس، کاشان، ایران.

  • 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 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: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715973474
    Phone: +98 31 5544 3022
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Barij Research Center of Medicinal Herbs
    Name of organization / entity - Persian: مرکز تحقیقات گیاهان دارویی باریج
    Full name of responsible person - English: Miss L.Hejazi
    Full name of responsible person - Persian: سرکار خانم لاله حجازی
    Street address - English: Kashan
    Street address - Persian: کیلومتر 44 جاده کاشان-مشهد اردهال
    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: Barij Research Center of Medicinal Herbs
    Name of organization / entity - Persian: مرکز تحقیقات گیاهان دارویی باریج
    Full name of responsible person - English: Miss L.Hejazi
    Full name of responsible person - Persian: سرکار خانم لاله حجازی
    Street address - English: Kashan
    Street address - Persian: کیلومتر 44 جاده کاشان-مشهد اردهال
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 1165936315
    Phone: +98 21 4426 7992
    Fax:
    Email: info@barijessence.com
    Web page address:
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    Private
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    Domestic
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    Industry
    #2
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research of Kashan University of Medical Science
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr Gholam Ali Hamidi
    Full name of responsible person - Persian: دکتر غلامعلی حمیدی
    Street address - English: Kashan university of Medical Science, Kashan
    Street address - Persian: کاشان، دانشگاه علوم پزشکی کاشان
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    empty
    Yes
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    empty
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    Vice chancellor for research of Kashan University of Medical Science
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    معاونت پژوهشی دانشگاه علوم پزشکی کاشان
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  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Barij Research Center of Medicinal Herbs
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr.M. Taghizadeh
    Full name of responsible person - Persian: دکتر محسن تقی زاده
    Position - English: PHD
    Position - Persian: دکتری تخصصی
    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 86 4446 5112
    Mobile: 00
    Fax:
    Email: mohsenta44@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Barij Research Center of Medicinal Herbs
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr.M. Taghizadeh
    Full name of responsible person - Persian: دکتر محسن تقی زاده
    Position - English: PHD
    Position - Persian: دکتری تخصصی
    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: 8715973474
    Phone: +98 86 4446 5112
    Mobile: +98 913 363 3213
    Fax:
    Email: mohsenta44@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: Dr.Z.Asemi
    Full name of responsible person - Persian: دکتر ذات الله عاصمی
    Position - English: PHD
    Position - Persian: دکتری تخصصی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan University Of Medical Sciences, Kashan
    Street address - Persian: کاشان. دانشگاه علوم پزشکی
    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 5554 0021
    Mobile: 00
    Fax:
    Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr.Z.Asemi
    Full name of responsible person - Persian: دکتر ذات الله عاصمی
    Position - English: PHD
    Position - Persian: دکتری تخصصی
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan University Of Medical Sciences, Kashan
    Street address - Persian: کاشان. دانشگاه علوم پزشکی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8715973474
    Phone: +98 31 5554 0021
    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: Barij Research Center of Medicinal Herbs
    Name of organization / entity - Persian: مرکز تحقیقات گیاهان دارویی باریج
    Full name of responsible person - English: M.Mahlouji
    Full name of responsible person - Persian: خانم مهناز محلوجی
    Position - English: Clinical Reserch Expert
    Position - Persian: کارشناس تحقیقات بالینی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan Mashhad Ardehal Road, KM44
    Street address - Persian: کیلومتر 44 جاده کاشان-مشهد اردهال
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 86 4446 5112
    Mobile: 00
    Fax:
    Email: mahnaz.mahlouji@yahoo.com; mahnaz.mahlouji@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Barij Research Center of Medicinal Herbs
    Name of organization / entity - Persian: مرکز تحقیقات گیاهان دارویی باریج
    Full name of responsible person - English: M.Mahlouji
    Full name of responsible person - Persian: خانم مهناز محلوجی
    Position - English: Clinical Reserch Expert
    Position - Persian: کارشناس تحقیقات بالینی
    Latest degree: phd
    Area of specialty/work: 41
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan Mashhad Ardehal Road, KM44
    Street address - Persian: کیلومتر 44 جاده کاشان-مشهد اردهال
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1165936315
    Phone: +98 86 4446 5112
    Mobile: +98 913 361 5446
    Fax:
    Email: mahnaz.mahlouji@yahoo.com
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    There is no decision for this matter.
    empty
    هنوز تصمیمی در این زمینه گرفته نشده است.

Protocol summary

Study aim
The aim of this study is to determine the effects of Mulbery alba leave extract on the metabolic profile, inflammatory factors, and biomarkers of oxidative stress and ALT and AST enzymes on patients with TDM2.
Design
A randomized, double-blind, controlled clinical trial on 60 patients. Computer-generated random numbers were utilized for random assignment.
Settings and conduct
60 eligible patients with type 2 diabetes and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Patients will be given 300 mg capsule of mulberry leaf extract twice a day (intervention group) or placebo (control group). Fasting blood samples will be taken from patients at the beginning of the study and 12 weeks after the intervention. Then, variables including fasting plasma glucose, serum insulin, HOMA-IR, lipid profile, QUICKI, CRP, NO, total antioxidant capacity, total plasma glutathione, MDA, hemoglobin A1C, and ALT and AST enzymes Will be measured.
Participants/Inclusion and exclusion criteria
Taking berry extract in the last three months; Changes in glucose-lowering drugs during the study; Taking anticoagulants; Pregnancy or lactation; Malignancies; Chronic liver disease.
Intervention groups
The intervention consists of taking mulberry extract supplement (300 mg) twice per a day during 12 weeks, which is prepared by the Pharmaceutical Company of Barij Essence in Kashan, Iran, previously confirmed by the Food and Drug Administration. The placebo capsules contains starch produced by the same company.
Main outcome variables
Fasting plasma glucose; serum insulin; HOMA-IR; lipid profile; QUICKI; CRP; NO; total antioxidant capacity; total plasma glutathione; MDA; hemoglobin A1C

General information

Reason for update
Due to alterations appeared during the trial.
Acronym
IRCT registration information
IRCT registration number: IRCT2016081312438N21
Registration date: 2017-01-12, 1395/10/23
Registration timing: registered_while_recruiting

Last update: 2021-12-06, 1400/09/15
Update count: 2
Registration date
2017-01-12, 1395/10/23
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal Herbs
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Morus Alba leaves’s extract supplement on blood glucose, lipid profiles, HbA1c, insulin resistance ,inflammation factors and oxidative stress biomarkers in patients with type 2 diabetes
Public title
Effect of Morus Alba leaves’s extract supplement on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
T2DM patients with FPG of more than 126 mg/dL and less than 200 mg/dL.
Exclusion criteria:
Mulberry extract intake in the last three months. Changing in glucose-lowering medications. Taking anticoagulants during the study. Pregnancy or lactating. Malignancies. Chronic hepatic diseases.
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Computer-generated random numbers will be utilized for random assignment. Clinic-trained personnel will be performed all participant enrollment, random allocation and group assignment.
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 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
Randomized based on table of random numbers

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2016-09-28, 1395/07/07
Ethics committee reference number
IR.KAUMS.REC.1395.57

Health conditions studied

1

Description of health condition studied
Diabets type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
HOMA-IR
Timepoint
Before the beginning of the study and 12 weeks after
Method of measurement
Enzymatic

Secondary outcomes

1

Description
Fasting plasma glucose (FPG)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
ELISA

2

Description
Insulin
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
ELISA

3

Description
QUICKI
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
ELISA

4

Description
HbA1C
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
ELISA

5

Description
Triglyceride
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic

6

Description
Very low density lipoptotein (VLDL)-Cholesterol
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic

7

Description
Cholesterol
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic

8

Description
Low density lipoptotein (LDL)-Cholesterol
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic

9

Description
High density lipoptotein (HDL)-Cholesterol
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic

10

Description
Alanine transaminase (ALT)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic

11

Description
Aspartate transaminase (AST)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic

12

Description
C reactive protein (CRP)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic

13

Description
Nitric oxide (NO)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Spectrophotometry

14

Description
Total antioxidant capacity (TAC)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Spectrophotometry

15

Description
Glutathione (GSH)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Spectrophotometry

16

Description
Malondialdehyde (MDA)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Spectrophotometry

Intervention groups

1

Description
Intervention group:300 mg Morus Alba leaves’s extract capsule, 2 times a day; 12 weeks; produced by Barij esans Co, Kashan, Iran.
Category
Treatment - Drugs

2

Description
Control group: placebo capsule; 2 times a day; 12 weeks; produced by Barij esans Co, Kashan, Iran.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
asemi_r@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss L.Hejazi
Street address
Kashan
City
Kashan
Province
Isfehan
Postal code
1165936315
Phone
+98 21 4426 7992
Email
info@barijessence.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Research Center of Medicinal Herbs
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Dr.M. Taghizadeh
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 86 4446 5112
Fax
Email
mohsenta44@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Z.Asemi
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0021
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
M.Mahlouji
Position
Clinical Reserch Expert
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Province
Isfehan
Postal code
1165936315
Phone
+98 86 4446 5112
Fax
Email
mahnaz.mahlouji@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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