Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin3، NT-proBNP، ApoB100، oxLDL، ADMA، LCAT activity، sCD163 to sTWEAK ration and Urea nitrogen in patients with chronic heart failure
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Protocol summary
Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin 3, N-terminal prohormone of brain natriuretic peptide, Apo B100, Apo A1, oxidized low density lipoprotein, ADMA, lecithin Cholesterol acyl transferase activity, Paraoxonase1 activity, sCD163 to sTWEAK ration and lipid profile in patients with chronic heart failure
Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin 3, N-terminal prohormone of brain natriuretic peptide, Apo B100, oxidized low density lipoprotein, ADMA, lecithin Cholesterol acyl transferase activity, sCD163 to sTWEAK ration and urea nitrogen in patients with chronic heart failure
Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin 3, N-terminal prohormone of brain natriuretic peptide, Apo B100, Apo A1, oxidized low density lipoprotein, ADMA, lecithin Cholesterol acyl transferase activity, Paraoxonase1 activity, sCD163 to sTWEAK ration and lipid profileurea nitrogen in patients with chronic heart failure
مقایسه مصرف ماست پروبیوتیک و ماست معمولی بر شاخص های سرمی پنتراکسین 3، N ترمینال پروهورمون حاصل از پپتید ناتریورتیک مغزی، آپو B100، آپو A1، لیپوپروتئین با دانسیته پایین اکسید شده، ADMA، فعالیت لستین کلسترول آسیل ترانسفراز، فعالیت پاراکسوناز1، نسبت sCD163 به sTWEAK و پروفایل لیپیدی در بیماران مبتلا به نارسایی قلبی مزمن
مقایسه مصرف ماست پروبیوتیک و ماست معمولی بر شاخص های سرمی پنتراکسین 3، N ترمینال پروهورمون حاصل از پپتید ناتریورتیک مغزی، آپو B100، لیپوپروتئین با دانسیته پایین اکسید شده، ADMA، فعالیت لستین کلسترول آسیل ترانسفراز، نسبت sCD163 به sTWEAK و نیتروژن اوره در بیماران مبتلا به نارسایی قلبی مزمن
مقایسه مصرف ماست پروبیوتیک و ماست معمولی بر شاخص های سرمی پنتراکسین 3، N ترمینال پروهورمون حاصل از پپتید ناتریورتیک مغزی، آپو B100، آپو A1، لیپوپروتئین با دانسیته پایین اکسید شده، ADMA، فعالیت لستین کلسترول آسیل ترانسفراز، فعالیت پاراکسوناز1، نسبت sCD163 به sTWEAK و پروفایل لیپیدینیتروژن اوره در بیماران مبتلا به نارسایی قلبی مزمن
General information
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Adding a new factor (Urea nitrogen) and removing deleted factors (ApoA1 and PON1 activity and lipid profile)
Adding a new factor (Urea nitrogen) and removing deleted factors (ApoA1 and PON1 activity and lipid profile)
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افزودن فاکتور جدید (Urea nitrogen) و حذف فاکتورهایی که حذف شده اند ( ApoA1 و PON1 activity و پروفایل لیپیدی)
افزودن فاکتور جدید (Urea nitrogen) و حذف فاکتورهایی که حذف شده اند ( ApoA1 و PON1 activity و پروفایل لیپیدی)
Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin3، NT-proBNP، ApoB100، ApoA1، oxLDL، ADMA، LCAT activity، PON1 activity، sCD163 to sTWEAK ration and lipid profile in patients with chronic heart failure
Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin3، NT-proBNP، ApoB100، oxLDL، ADMA، LCAT activity، sCD163 to sTWEAK ration and Urea nitrogen in patients with chronic heart failure
Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin3، NT-proBNP، ApoB100، ApoA1، oxLDL، ADMA، LCAT activity، PON1 activity، sCD163 to sTWEAK ration and lipid profileUrea nitrogen in patients with chronic heart failure
مقایسه مصرف ماست پروبیوتیک و ماست معمولی بر شاخص های سرمی Pentraxin3 ،NTproBNP ،ApoB100 ،ApoA1 ،oxLDL ،ADMA ،LCAT activity ،PON1 activity نسبت sCD163 به sTWEAK و پروفایل لیپیدی در بیماران مبتلا به نارسایی قلبی مزمن
مقایسه مصرف ماست پروبیوتیک و ماست معمولی بر شاخص های سرمی Pentraxin3 ،NTproBNP ،ApoB100 ،oxLDL ،ADMA ،LCAT activity نسبت sCD163 به sTWEAK وUrea nitrogen در بیماران مبتلا به نارسایی قلبی مزمن
مقایسه مصرف ماست پروبیوتیک و ماست معمولی بر شاخص های سرمی Pentraxin3 ،NTproBNP ،ApoB100 ،ApoA1 ،oxLDL ،ADMA ،LCAT activity ،PON1 activity نسبت sCD163 به sTWEAK و پروفایل لیپیدیوUrea nitrogen در بیماران مبتلا به نارسایی قلبی مزمن
Measurement of Serum Apolipoprotein A1 at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Measurement of Serum Asymmetric dimethylarginine at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Measurement of Serum Apolipoprotein A1Asymmetric dimethylarginine at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
اندازه گیری آپولیپوپروتئینA1 سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
اندازه گیری آسیمتریک دی متیل آرژنین سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
اندازه گیری آپولیپوپروتئینA1آسیمتریک دی متیل آرژنین سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
آسیمتریک دی متیل آرژنینفعالیت لستین کلسترول آسیل ترانسفراز سرم
Measurement of Serum Asymmetric dimethylarginine at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Measurement of Serum lecithin Cholesterol acyl transferase activity at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Measurement of Serum Asymmetric dimethylargininelecithin Cholesterol acyl transferase activity at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
اندازه گیری آسیمتریک دی متیل آرژنین سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
اندازه گیری فعالیت لستین کلسترول آسیل ترانسفراز سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
اندازه گیری آسیمتریک دی متیل آرژنینفعالیت لستین کلسترول آسیل ترانسفراز سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
Serum lecithin Cholesterol acyl transferase activitysCD163 to sTWEAK ration
فعالیت لستین کلسترول آسیل ترانسفراز سرم
نسبت sCD163 به sTWEAK سرم
فعالیت لستین کلسترول آسیل ترانسفرازنسبت sCD163 به sTWEAK سرم
Measurement of Serum lecithin Cholesterol acyl transferase activity at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Measurement of Serum sCD163 to sTWEAK ration at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Measurement of Serum lecithin Cholesterol acyl transferase activitysCD163 to sTWEAK ration at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
اندازه گیری فعالیت لستین کلسترول آسیل ترانسفراز سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
اندازه گیری نسبت sCD163 به sTWEAK سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
اندازه گیری فعالیت لستین کلسترول آسیل ترانسفرازنسبت sCD163 به sTWEAK سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
#4
Serum paraoxonase1 activity
Serum urea nitrogen
Serum paraoxonase1 activityurea nitrogen
فعالیت پاراکسوناز 1 سرم
نیتروژن اوره سرم
فعالیت پاراکسوناز 1نیتروژن اوره سرم
Measurement of Serum paraoxonase1 activity at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Measurement of Serum urea nitrogen at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Measurement of Serum paraoxonase1 activityurea nitrogen at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
اندازه گیری فعالیت پاراکسوناز 1 سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
اندازه گیری نیتروژن اوره سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
اندازه گیری فعالیت پاراکسوناز 1نیتروژن اوره سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
ELISA kit
Enzymatic colorimetric
ELISA kitEnzymatic colorimetric
کیت الایزا
رنگ سنجی آنزیمی
کیت الایزارنگ سنجی آنزیمی
#5
Serum total cholesterol
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Serum total cholesterol
کلسترول تام سرم
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کلسترول تام سرم
Measurement of Serum total cholesterol at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
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Measurement of Serum total cholesterol at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
اندازه گیری کلسترول تام سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
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اندازه گیری کلسترول تام سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
Enzymatic colorimetric
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Enzymatic colorimetric
رنگ سنجی آنزیمی
empty
رنگ سنجی آنزیمی
#6
Serum Triglyceride
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Serum Triglyceride
تری گلیسیرید سرم
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تری گلیسیرید سرم
Measurement of Serum Triglyceride at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
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Measurement of Serum Triglyceride at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
اندازه گیری تری گلیسیرید سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
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اندازه گیری تری گلیسیرید سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
Enzymatic colorimetric
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Enzymatic colorimetric
رنگ سنجی آنزیمی
empty
رنگ سنجی آنزیمی
#7
Serum high-density lipoprotein
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Serum high-density lipoprotein
لیپوپروتئین با دانسیته بالا سرم
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لیپوپروتئین با دانسیته بالا سرم
Measurement of Serum high-density lipoprotein at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
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Measurement of Serum high-density lipoprotein at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
اندازه گیری لیپوپروتئین با دانسیته بالا سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
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اندازه گیری لیپوپروتئین با دانسیته بالا سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
Enzymatic colorimetric
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Enzymatic colorimetric
رنگ سنجی آنزیمی
empty
رنگ سنجی آنزیمی
#8
Serum low-density lipoprotein
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Serum low-density lipoprotein
لیپوپروتئین با دانسیته پایین سرم
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لیپوپروتئین با دانسیته پایین سرم
Measurement of Serum low-density lipoprotein at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
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Measurement of Serum low-density lipoprotein at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
اندازه گیری لیپوپروتئین با دانسیته پایین سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
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اندازه گیری لیپوپروتئین با دانسیته پایین سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
Enzymatic colorimetric
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Enzymatic colorimetric
رنگ سنجی آنزیمی
empty
رنگ سنجی آنزیمی
#9
sCD163 to sTWEAK ration
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sCD163 to sTWEAK ration
نسبت sCD163 به sTWEAK سرم
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نسبت sCD163 به sTWEAK سرم
Measurement of Serum sCD163 to sTWEAK ration at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
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Measurement of Serum sCD163 to sTWEAK ration at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
اندازه گیری نسبت sCD163 به sTWEAK سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
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اندازه گیری نسبت sCD163 به sTWEAK سرم در ابتدای مطالعه( قبل از شروع مداخله) و انتهای مطالعه (10 هفته پس از شروع مصرف ماست پروبیوتیک) .
ELISA kit
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ELISA kit
کیت الایزا
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کیت الایزا
Protocol summary
Study aim
Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin 3, N-terminal prohormone of brain natriuretic peptide, Apo B100, oxidized low density lipoprotein, ADMA, lecithin Cholesterol acyl transferase activity, sCD163 to sTWEAK ration and urea nitrogen in patients with chronic heart failure
Design
the permuted block randomization will be used with quadruple blocks. According to the sample size of 90, 23 blocks will be produced using the online site (www.sealedenvelope.com).This study is in the third phase of clinical trial
Settings and conduct
The present study will be carried out as a double-blind randomized clinical trial in patients with chronic heart failure who referred to the Shahid Rajaee Cardiology Center. No changes in physical activity or diet are expected during the study.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: 1- Age range 30-70 years. 2. Having common symptoms of heart failure for at least 1 month.
3.Decreased LVEF (less than 40%). 4- Being in one of the NYHA classification steps 1-3
5- Desire to participate in the study and sign a written informed consent
Non-inclusion criteria:
1- Cases of other diseases and chronic and acute liver disorders, diabetes, thyroid disorders, severe renal dysfunction, pulmonary diseases, inflammatory diseases and Known autoimmune, cancer, rheumatoid arthritis, acute infection. 2- taking any nutritional supplement during the past month. 3- smoking and narcotic drugs consumption. 4- Intolerance to lactose and allergy to dairy products. 5- taking corticosteroid in the last 4 weeks
Intervention groups
1. Intervention group: receive 300 grams of probiotic yogurt per day for 10 weeks.
2. Control group :receive 300 grams of ordinary yogurt per day for 10 weeks.
Main outcome variables
Pentraxin 3 and oxLDL
General information
Reason for update
Adding a new factor (Urea nitrogen) and removing deleted factors (ApoA1 and PON1 activity and lipid profile)
Acronym
IRCT registration information
IRCT registration number:IRCT20091114002709N48
Registration date:2018-03-12, 1396/12/21
Registration timing:prospective
Last update:2019-11-05, 1398/08/14
Update count:2
Registration date
2018-03-12, 1396/12/21
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-12-06, 1397/09/15
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin3، NT-proBNP، ApoB100، oxLDL، ADMA، LCAT activity، sCD163 to sTWEAK ration and Urea nitrogen in patients with chronic heart failure
Public title
Comparison of probiotic yogurt and ordinary yogurt consumption in patients with chronic heart failure.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 30 to 70 years
Having common symptoms of heart failure for at least 1 month
decreased LVEF (≤40%)
Being in one of the NYHA classification steps 1-3
Desire to participate in the study and sign a written informed consent
Exclusion criteria:
suffering or having chronic and acute liver (hepatitis B, C, etc.) Diseases and other, diabetes, thyroid disorders, severe renal dysfunction (creatinine more than 300 millimol/liter), pulmonary disease, known inflammatory and autoimmune diseases, Cancer, Rheumatoid Arthritis, Acute Infection
taking any nutritional supplement during the past month
smoking and using narcotic drugs
Lactose intolerance and allergy to dairy products
taking Corticosteroid drug in the last 4 weeks
taking antibiotics over the past 3 months
History of Gastrointestinal Surgery
Taking anti-inflammatory drugs other than low dose of aspirin (one per day)
Having an artificial heart valve
History of rheumatic heart disease
Pregnancy and lactation
taking insulin
body mass index more than 30 Kilogram/meter²
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the permuted block randomization will be used with quadruple blocks. According to the sample size of 90 , 23 blocks will be produced using the online site (www.sealedenvelope.com).
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to apply concealment in the randomization process, unique codes will be used on yogurt containers, the code being generated by the software. By entering each individual into a study based on the produced sequence , the yogurt container in which the code is registered will be assigned to the individual.During the research, the random list is provided to the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators will not be aware of the assigned groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemat Express way, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-01-20, 1396/10/30
Ethics committee reference number
IR.IUMS.REC 1396.9511468002
Health conditions studied
1
Description of health condition studied
Chronic heart failure
ICD-10 code
I50.9
ICD-10 code description
Cardiac, heart or myocardial failure NOS
Primary outcomes
1
Description
Serum pentraxin3
Timepoint
Measurement of serum pentraxin3 at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Method of measurement
ELISA kit
2
Description
Serum oxidized low density lipoprotein
Timepoint
Measurement of serum oxidized low density lipoprotein at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Method of measurement
ELISA kit
Secondary outcomes
1
Description
Serum N-terminal prohormone of brain natriuretic peptide
Timepoint
Measurement of Serum N-terminal prohormone of brain natriuretic peptide at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Method of measurement
ELISA kit
2
Description
Serum Apolipoprotein B100
Timepoint
Measurement of Serum Apolipoprotein B100 at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Method of measurement
Immunoturbidimetry
3
Description
Serum Asymmetric dimethylarginine
Timepoint
Measurement of Serum Asymmetric dimethylarginine at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Measurement of Serum lecithin Cholesterol acyl transferase activity at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Method of measurement
ELISA kit
5
Description
sCD163 to sTWEAK ration
Timepoint
Measurement of Serum sCD163 to sTWEAK ration at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Method of measurement
ELISA kit
6
Description
Serum urea nitrogen
Timepoint
Measurement of Serum urea nitrogen at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption).
Method of measurement
Enzymatic colorimetric
Intervention groups
1
Description
Intervention group: Consumption of Probiotic yogurt (300 gr/day for 10 weeks). Probiotic yogurt is prepared in the form of low-fat yogurt (1.5% fat) containing 10⁹ cfu /gr of Lactobacillus acidophilus La5 and lactobacillus bifidobacterium Bb12 by Pak dairy factory.
Category
Placebo
2
Description
Control group: Consumption of ordinary yogurt (300 gr/day for 10 weeks) that is prepared by Pak dairy factory.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid rajaie cardiovascular, medical and research center
Full name of responsible person
Dr Nasim naderi
Street address
Shahid Rajaei Cardiovascular Medical and Research Center, Niayesh Intersection, Next to Mellat Park, Valiasr Ave, Tehran Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 8862 2755
Fax
+98 21 2204 2026
Email
Naderi.nasim@gmail.com
Web page address
http://www.rhc.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Seyed Kazem Malakooti
Street address
Iran university of medical science, Hemmat expressway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
Shidfar.f@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr.Farzad Shidfar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of health, Iran university of medical science, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2755
Fax
+98 21 8862 2533
Email
Shidfar.f@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Farzad Shidfar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of health, Iran university of medical science, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2755
Fax
+98 21 8862 2533
Email
Shidfar.f@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behnaz Pourrajab
Position
Ms.c student in nutrition science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of health, Iran university of medical science, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 11 5522 3547
Email
Behnazpourrajab@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only a part of the data will be shared, such as information about primary outcomes and Etc.
When the data will become available and for how long
The access period will be 6 months after publication of the results.
To whom data/document is available
The obtained data from current study will be available only for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Six months after the publication of the papers from this study, the data obtained will be available to the applicant researchers for further analysis.
From where data/document is obtainable
Applicants can be contacted with correspond author by e-mail or postal address to receive the requested data.
Postal address: Nutrition department, School of health, Iran University of Medical Sciences, Hemmat expressway, Tehran
Phon number:0098 21 8862 2755
E-mail: Farzadshidfar@yahoo.com
What processes are involved for a request to access data/document
Applicants will be able to access the obtained data from current study by sending an email to the corresponding author, after a maximum of one week.