Clinical trial of the effect of combined probiotic and vitamin D supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease
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 combined probiotic and vitamin D supplementation on metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD). Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with CHD referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive combined probiotic and vitamin D (n=30) or placebo (n=30). Probiotic, vitamin D and placebo capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
empty
Objective: The aim of this study is to determine the effects of combined probiotic and vitamin D supplementation on metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD). Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with CHD referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive combined probiotic and vitamin D (n=30) or placebo (n=30). Probiotic, vitamin D and placebo capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب پروبیوتیک و ویتامین D بر پروفایل های متابولیک در بیماران دیابتی تیپ 2 با بیماری کرونر قلبی است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: افراد 85-45 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به بیماری کرونر قلبی ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت ترکیب پروبیوتیک و ویتامین دی (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های پروبیوتیک، ویتامین D و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: مارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
empty
هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب پروبیوتیک و ویتامین D بر پروفایل های متابولیک در بیماران دیابتی تیپ 2 با بیماری کرونر قلبی است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: افراد 85-45 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به بیماری کرونر قلبی ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت ترکیب پروبیوتیک و ویتامین دی (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های پروبیوتیک، ویتامین D و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: مارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
empty
Objective: The aim of this study is to determine the effects of combined probiotic and vitamin D supplementation on metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD).
Objective: The aim of this study is to determine the effects of combined probiotic and vitamin D supplementation on metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD).
empty
هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب پروبیوتیک و ویتامین D بر پروفایل های متابولیک در بیماران دیابتی تیپ 2 با بیماری کرونر قلبی است.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب پروبیوتیک و ویتامین D بر پروفایل های متابولیک در بیماران دیابتی تیپ 2 با بیماری کرونر قلبی است.
empty
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive melatonin supplements (n=30) or placebo (n=30).
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive melatonin supplements (n=30) or placebo (n=30).
empty
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. بیماران به دو گروه برای دریافت مکمل یاری (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. بیماران به دو گروه برای دریافت مکمل یاری (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
empty
Among diabetic patients and CHD referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Among diabetic patients and CHD referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
empty
از بین بیماران مبتلا به دیابت و قلبی عروقی ارجاع شده به کلینیک قلب وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
از بین بیماران مبتلا به دیابت و قلبی عروقی ارجاع شده به کلینیک قلب وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
empty
Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes patients with coronary heart disease will be included in this study. Exclusion criteria: Exclusion criteria: Taking vitamin D, probiotic and/or synbiotic within the last 3 months, and patients with thyroid disorders.
Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes patients with coronary heart disease will be included in this study. Exclusion criteria: Exclusion criteria: Taking vitamin D, probiotic and/or synbiotic within the last 3 months, and patients with thyroid disorders.
empty
معیار ورود به مطالعه: افراد 85-45 ساله دیابتی تیپ 2 با بیماری کرونر قلبی وارد مطالعه خواهند شد. معیار خروج از مطالعه: گرفتن ویتامین دی، پروبیوتیک و/یا سین بیوتیک در طی سه ماه گذشته، بیماران مبتلا به اختلالات تیروئید.
معیار ورود به مطالعه: افراد 85-45 ساله دیابتی تیپ 2 با بیماری کرونر قلبی وارد مطالعه خواهند شد. معیار خروج از مطالعه: گرفتن ویتامین دی، پروبیوتیک و/یا سین بیوتیک در طی سه ماه گذشته، بیماران مبتلا به اختلالات تیروئید.
empty
Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and vitamin D supplements (Zahravi, Tabriz, Iran), 50,000 IU vitamin D every 2 weeks, for 12 weeks orally. Control group: Probiotic and vitamin D placebo capsules (Barij essence, Kashan, Iran), probiotic placebo daily and vitamin D placebo every 2 weeks, for 12 weeks orally.
Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and vitamin D supplements (Zahravi, Tabriz, Iran), 50,000 IU vitamin D every 2 weeks, for 12 weeks orally. Control group: Probiotic and vitamin D placebo capsules (Barij essence, Kashan, Iran), probiotic placebo daily and vitamin D placebo every 2 weeks, for 12 weeks orally.
empty
گروه مداخله: مکمل ترکیب پروبیوتیک (زیست تخمیر، تهران، ایران) شامل لاکتوباسیلوس اسیدوفیلوس 109×2، بیفیدوباکتریوم بیفیدوس 109×2، لاکتوفیلوس روتری 109×2، لاکتوباسیلوس فرمنتوم 109×2 روزانه و ویتامین D (زهراوی، تبریز، ایران)، 50000 واحد هر دو هفته، به صورت خوراکی برای 12 هفته. گروه کنترل: کپسول پلاسبوهای پروبیوتیک و ویتامین D (باریج اسانس، کاشان، ایران)، پلاسبوی پروبیوتیک روزانه و پلاسبوی ویتامین D هر دو هفته، به صورت خوراکی برای 12 هفته.
گروه مداخله: مکمل ترکیب پروبیوتیک (زیست تخمیر، تهران، ایران) شامل لاکتوباسیلوس اسیدوفیلوس 109×2، بیفیدوباکتریوم بیفیدوس 109×2، لاکتوفیلوس روتری 109×2، لاکتوباسیلوس فرمنتوم 109×2 روزانه و ویتامین D (زهراوی، تبریز، ایران)، 50000 واحد هر دو هفته، به صورت خوراکی برای 12 هفته. گروه کنترل: کپسول پلاسبوهای پروبیوتیک و ویتامین D (باریج اسانس، کاشان، ایران)، پلاسبوی پروبیوتیک روزانه و پلاسبوی ویتامین D هر دو هفته، به صورت خوراکی برای 12 هفته.
empty
Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
empty
پيامدها: مارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: مارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
1
1
1
1
1
1
2
3
23
2017-09-02, 1396/06/11
2017-08-29, 1396/06/07
2017-0908-0229 00:00:00
Subjects aged 45-85 years
Diagnosed with type 2 diabetes and CHD
Subjects aged 45-85 years Diagnosed with type 2 diabetes and CHD
افراد 85-45 ساله
مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی
افراد 85-45 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی
Taking vitamin D, probiotic and/or synbiotic within the last 3 months
Patients with thyroid disorders
Taking vitamin D, probiotic and/or synbiotic within the last 3 months Patients with thyroid disorders
گرفتن ویتامین دی، پروبیوتیک و/یا سین بیوتیک در طی سه ماه گذشته
بیماران مبتلا به اختلالات تیروئید
گرفتن ویتامین دی، پروبیوتیک و/یا سین بیوتیک در طی سه ماه گذشته بیماران مبتلا به اختلالات تیروئید
empty
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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.
شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
empty
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<65 and ≥65 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<65 and ≥65 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
empty
برای کاهش اثرات مخدوش کنندگی بالقوه، همه شرکت کنندگان بر اساس نمایه توده بدنی (<25 و ≥25 کیلوگرم بر متر مربع) و سن (<65 و ≥65) تصادفی سازی لایه ای خواهند شد. سپس، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل یاری یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری انجام خواهد شد.
برای کاهش اثرات مخدوش کنندگی بالقوه، همه شرکت کنندگان بر اساس نمایه توده بدنی (<25 و ≥25 کیلوگرم بر متر مربع) و سن (<65 و ≥65) تصادفی سازی لایه ای خواهند شد. سپس، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل یاری یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری انجام خواهد شد.
empty
empty
Secondary outcomes
#1
empty
Beck Depression Inventory
Beck Depression Inventory
empty
پرسشنامه افسردگی بک
پرسشنامه افسردگی بک
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Questionnaire
Questionnaire
empty
پرسشنامه
پرسشنامه
#2
empty
Systolic blood pressure
Systolic blood pressure
empty
فشار خون سیستولیک
فشار خون سیستولیک
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Manometer
Manometer
empty
مانومتر
مانومتر
#3
empty
Diastolic blood pressure
Diastolic blood pressure
empty
فشار خون سیستولیک
فشار خون سیستولیک
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Manometer
Manometer
empty
مانومتر
مانومتر
#4
empty
Beck Anxiety Inventory
Beck Anxiety Inventory
empty
پرسشنامه اضطراب بک
پرسشنامه اضطراب بک
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Questionnaire
Questionnaire
empty
پرسشنامه
پرسشنامه
#5
empty
General Health Questionnaire
General Health Questionnaire
empty
پرسشنامه سلامت عمومی
پرسشنامه سلامت عمومی
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Questionnaire
Questionnaire
empty
پرسشنامه
پرسشنامه
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: 8715988141
Phone: +98 31 5546 3378
Fax:
Email: asemi_r@yahoo.com
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: 8715988141 Phone: +98 31 5546 3378 Fax: Email: asemi_r@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5546 3378
Fax:
Email: Hamidi-gh@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Gholamali Hamidi Full name of responsible person - Persian: غلامعلی حمیدی Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8715988141 Phone: +98 31 5546 3378 Fax: Email: Hamidi-gh@kaums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Ph.D of Nutrition
Position - Persian: دکترای تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Ph.D of Nutrition
Position - Persian: دکترای تغذیه
Latest degree: phd
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: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_r@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: Ph.D of Nutrition Position - Persian: دکترای تغذیه Latest degree: phd 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: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8715988141 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; 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: Ph.D of Nutrition
Position - Persian: دکترای تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Ph.D of Nutrition
Position - Persian: دکترای تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 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: 8715988141
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_r@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: Ph.D of Nutrition Position - Persian: دکترای تغذیه Latest degree: phd Area of specialty/work: 034 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: 8715988141 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English:
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: PhD of Nutrition
Position - Persian: دکترای تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 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: 8715988141
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_r@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: PhD of Nutrition Position - Persian: دکترای تغذیه Latest degree: phd Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 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: 8715988141 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
Undecided - It is not yet known if there will be a plan to make this available.
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.
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 combined probiotic and vitamin D supplementation on metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD).
Design
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive melatonin supplements (n=30) or placebo (n=30).
Settings and conduct
Among diabetic patients and CHD referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes patients with coronary heart disease will be included in this study. Exclusion criteria: Exclusion criteria: Taking vitamin D, probiotic and/or synbiotic within the last 3 months, and patients with thyroid disorders.
Intervention groups
Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and vitamin D supplements (Zahravi, Tabriz, Iran), 50,000 IU vitamin D every 2 weeks, for 12 weeks orally. Control group: Probiotic and vitamin D placebo capsules (Barij essence, Kashan, Iran), probiotic placebo daily and vitamin D placebo every 2 weeks, for 12 weeks orally.
Main outcome variables
Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017073033941N4
Registration date:2017-08-28, 1396/06/06
Registration timing:registered_while_recruiting
Last update:2019-09-20, 1398/06/29
Update count:1
Registration date
2017-08-28, 1396/06/06
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-08-17, 1396/05/26
Expected recruitment end date
2017-08-29, 1396/06/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined probiotic and vitamin D supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease
Public title
Effect of combined probiotic and vitamin D supplementation in treatment of coronary heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects aged 45-85 years
Diagnosed with type 2 diabetes and CHD
Exclusion criteria:
Taking vitamin D, probiotic and/or synbiotic within the last 3 months
Patients with thyroid disorders
Age
From 45 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<65 and ≥65 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2017-08-16, 1396/05/25
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.36
Health conditions studied
1
Description of health condition studied
Coronary Heart Disease
ICD-10 code
I25.9
ICD-10 code description
Chronic ischaemic heart disease, unspecified
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
Secondary outcomes
1
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
5
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
9
Description
Beck Depression Inventory
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
10
Description
Systolic blood pressure
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Manometer
11
Description
Diastolic blood pressure
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Manometer
12
Description
Beck Anxiety Inventory
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
13
Description
General Health Questionnaire
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and vitamin D supplements (Zahravi, Tabriz, Iran), 50,000 IU vitamin D every 2 weeks, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Probiotic and vitamin D placebo capsules (Barij essence, Kashan, Iran), probiotic placebo daily and vitamin D placebo every 2 weeks, for 12 weeks orally.
Category
Treatment - Drugs
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
8715988141
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5546 3378
Email
Hamidi-gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Ph.D of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Ph.D of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
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