The effect of weight loss diet with and without Hydroxy citric Acid supplement derived from Garcinia Cambogia on the serum hepcidin level and liver function in women with NAFLD: A randomized controlled clinical trial
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Protocol summary
This randomized single blind controlled clinical trial will be performed to investigate the effect of Hydroxy citric acid on hepcidin level of serum and liver enzyme levels and sonographic image on 40 women that are 18-50 years old with NAFLD confirmed by sonographic image that will be with moderate level of physical activity and BMI of 27/5-40 kg/m2 and not being lactation or pregnant or menopause ,without any liver diseases or metabolic disorders such as diabet or thyroid disorders and not using drugs for liver disorders. Patients will be randomized in 2 groups:control group that will get just weight loss diet,also intervention group get weight loss diet plus 6 tablets of Hydroxy citric acid supplements derived from Garcinia Cambogia (two tablets,30 minutes before breakfast,lunch,dinner) daily for 2 months.at baseline and at the end of study from all of the participants will be taken 7 cc blood samples after 12 hours fasting for measuring hepcidin level of serum and liver enzymes.at baseline and at the end of study: sonographic image will take, anthropometric indices will be measured,physical activity questionnaires and appetite questionnaires will be completed. and 24 hours dietary recall at baseline- middle-end of study will be completed.
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This randomized single blind controlled clinical trial will be performed to investigate the effect of Hydroxy citric acid on hepcidin level of serum and liver enzyme levels and sonographic image on 40 women that are 18-50 years old with NAFLD confirmed by sonographic image that will be with moderate level of physical activity and BMI of 27/5-40 kg/m2 and not being lactation or pregnant or menopause ,without any liver diseases or metabolic disorders such as diabet or thyroid disorders and not using drugs for liver disorders. Patients will be randomized in 2 groups:control group that will get just weight loss diet,also intervention group get weight loss diet plus 6 tablets of Hydroxy citric acid supplements derived from Garcinia Cambogia (two tablets,30 minutes before breakfast,lunch,dinner) daily for 2 months.at baseline and at the end of study from all of the participants will be taken 7 cc blood samples after 12 hours fasting for measuring hepcidin level of serum and liver enzymes.at baseline and at the end of study: sonographic image will take, anthropometric indices will be measured,physical activity questionnaires and appetite questionnaires will be completed. and 24 hours dietary recall at baseline- middle-end of study will be completed.
این کارآزمایی بالینی تصادفی یک سو کور کنترل دار به منظور بررسی اثر مکمل اسید هیدروکسی سیتریک بر سطح سرمی هپسیدین و آنزیم های کبدی و تصاویر سونوگرافی کبدی بر روی 40 زن مبتلا به NAFLD که 50-18 سال سن دارند و توسط سونوگرافی کبدی NAFLD شان تائید شده اند و دارای نمایه توده بدنی 40-27/5کیلوگرم بر متر مربع و سطح فعالیت بدنی متوسط دارند و باردار و یا شیرده و یا یائسه نبوده و هیچ بیماری کبدی و یا متابولیکی مانند دیابت و یا بیماری های مرتبط با تیروئید ندارند و دارویی برای درمان بیماری کبدی مصرف نمی کنند انجام می شود. بیماران در دو گروه به صورت تصادفی تقسیم خواهند شد. گروه اول به عنوان "گروه کنترل" بوده و فقط رژیم کاهش وزن را به مدت دو ماه دریافت می کند، در حالی که گروه دوم که "گروه مداخله" بوده، رژیم کاهش وزن را همراه با مصرف روزانه 6 عدد مکمل اسید هیدروکسی سیتریک استخراج شده از Garcinia Cambogia که به صورت قرص بوده، به مدت 2 ماه به صورت دو عدد نیم ساعت قبل از صبحانه- نهار- شام دریافت می کند. ازتمامی افراد در ابتدا و انتها مطالعه 7 سی سی خون بعد از 12 ساعت ناشتایی به منظور تعیین سطح سرمی هپسیدین و آنزیم های کبدی خونگیری می شود. همچنین در ابتدا و انتهای مطالعه: سونوگرافی کبدی، اندازه گیری های تن سنجی و تکمیل پرسشنامه سطح فعالیت بدنی و پرسشنامه اشتها انجام خواهد شد و 24 ساعت یادآمد خوراک نیز در ابتدا- وسط و انتهای مطالعه تکمیل خواهد شد.
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این کارآزمایی بالینی تصادفی یک سو کور کنترل دار به منظور بررسی اثر مکمل اسید هیدروکسی سیتریک بر سطح سرمی هپسیدین و آنزیم های کبدی و تصاویر سونوگرافی کبدی بر روی 40 زن مبتلا به NAFLD که 50-18 سال سن دارند و توسط سونوگرافی کبدی NAFLD شان تائید شده اند و دارای نمایه توده بدنی 40-27/5کیلوگرم بر متر مربع و سطح فعالیت بدنی متوسط دارند و باردار و یا شیرده و یا یائسه نبوده و هیچ بیماری کبدی و یا متابولیکی مانند دیابت و یا بیماری های مرتبط با تیروئید ندارند و دارویی برای درمان بیماری کبدی مصرف نمی کنند انجام می شود. بیماران در دو گروه به صورت تصادفی تقسیم خواهند شد. گروه اول به عنوان "گروه کنترل" بوده و فقط رژیم کاهش وزن را به مدت دو ماه دریافت می کند، در حالی که گروه دوم که "گروه مداخله" بوده، رژیم کاهش وزن را همراه با مصرف روزانه 6 عدد مکمل اسید هیدروکسی سیتریک استخراج شده از Garcinia Cambogia که به صورت قرص بوده، به مدت 2 ماه به صورت دو عدد نیم ساعت قبل از صبحانه- نهار- شام دریافت می کند. ازتمامی افراد در ابتدا و انتها مطالعه 7 سی سی خون بعد از 12 ساعت ناشتایی به منظور تعیین سطح سرمی هپسیدین و آنزیم های کبدی خونگیری می شود. همچنین در ابتدا و انتهای مطالعه: سونوگرافی کبدی، اندازه گیری های تن سنجی و تکمیل پرسشنامه سطح فعالیت بدنی و پرسشنامه اشتها انجام خواهد شد و 24 ساعت یادآمد خوراک نیز در ابتدا- وسط و انتهای مطالعه تکمیل خواهد شد.
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The aim of the present study is to investigate the effects of a weight loss diet with or without Hydroxy citric acid supplementation on hepcidin level of serum and liver enzymes and sonographic image in obese women with Non Alcoholic Fatty Liver Disease .
The aim of the present study is to investigate the effects of a weight loss diet with or without Hydroxy citric acid supplementation on hepcidin level of serum and liver enzymes and sonographic image in obese women with Non Alcoholic Fatty Liver Disease .
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هدف مطالعه حاضر بررسی تأثیر رژیم غذایی کاهش وزن با یا بدون مکمل یاری اسید هیدروکسی سیتریک بر سطح سرمی هپسیدین و آنزیم های کبدی و تصاویر سونوگرافی کبدی در زنان چاق مبتلا به کبد چرب غیر الکلی می باشد.
هدف مطالعه حاضر بررسی تأثیر رژیم غذایی کاهش وزن با یا بدون مکمل یاری اسید هیدروکسی سیتریک بر سطح سرمی هپسیدین و آنزیم های کبدی و تصاویر سونوگرافی کبدی در زنان چاق مبتلا به کبد چرب غیر الکلی می باشد.
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Single-blind randomized clinical trial
Single-blind randomized clinical trial
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کارآزمایی بالینی تصادفی یک سو کور
کارآزمایی بالینی تصادفی یک سو کور
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The study will be conducted in the Sheikh Alrais clinic of Tabriz University of Medical Sciences, and supplementation duration will be 8 weeks.Patients will be blinded to the supplement they will receive.
The study will be conducted in the Sheikh Alrais clinic of Tabriz University of Medical Sciences, and supplementation duration will be 8 weeks.Patients will be blinded to the supplement they will receive.
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مطالعه در کلینیک شیخ الرئیس دانشگاه علوم پزشکی تبریز انجام خواهد شد و طول دوره مکمل یاری 8 هفته خواهد بود. بیماران نسبت به نوع مکمل مصرفی کور خواهند بود.
مطالعه در کلینیک شیخ الرئیس دانشگاه علوم پزشکی تبریز انجام خواهد شد و طول دوره مکمل یاری 8 هفته خواهد بود. بیماران نسبت به نوع مکمل مصرفی کور خواهند بود.
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40 patients with non alcoholic fatty liver disease and BMI of 30-40 Kg/m2 will be included in the study. Pregnancy, lactation, and co-morbidity of other metabolic or anemia or thalassemia are among the exclusion criteria of the study.
40 patients with non alcoholic fatty liver disease and BMI of 30-40 Kg/m2 will be included in the study. Pregnancy, lactation, and co-morbidity of other metabolic or anemia or thalassemia are among the exclusion criteria of the study.
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40 بیمار مبتلا به کبد چرب غیر الکلی با BMI بین 5/27و 40 Kg/m2 وارد مطالعه خواهند شد. بارداری، شیردهی و ابتلای همزمان به بیماری های کم خونی یا تالاسمی یا متابولیک از جمله معیارهای عدم ورود به مطالعه هستند.
40 بیمار مبتلا به کبد چرب غیر الکلی با BMI بین 5/27و 40 Kg/m2 وارد مطالعه خواهند شد. بارداری، شیردهی و ابتلای همزمان به بیماری های کم خونی یا تالاسمی یا متابولیک از جمله معیارهای عدم ورود به مطالعه هستند.
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The subjects in both groups will receive a weight loss diet considering their dietary habits. Patients in the intervention group will get 6 HCA tablets (2 tablets before breakfast, lunch, dinner).
The subjects in both groups will receive a weight loss diet considering their dietary habits. Patients in the intervention group will get 6 HCA tablets (2 tablets before breakfast, lunch, dinner).
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به افراد هر دو گروه رژیم غذایی کاهش وزن با در نظر گرفتن عادات غذایی هر فرد ارائه خواهد شد. بیماران در گروه مداخله، روزانه 6 عدد مکمل اسید هیدروکسی سیتریک (2عدد نیم ساعت قبل از صبحانه-نهار-شام) مصرف خواهند نمود.
به افراد هر دو گروه رژیم غذایی کاهش وزن با در نظر گرفتن عادات غذایی هر فرد ارائه خواهد شد. بیماران در گروه مداخله، روزانه 6 عدد مکمل اسید هیدروکسی سیتریک (2عدد نیم ساعت قبل از صبحانه-نهار-شام) مصرف خواهند نمود.
non-menopausal women with Non Alcoholic Fatty Liver Dieases 18-50 years
BMI=27/5-40 kg/m2
moderate activity level
non-menopausal women with Non Alcoholic Fatty Liver Dieases 18-50 years BMI=27/5-40 kg/m2 moderate activity level
زنان غیر یائسه مبتلا به کبد چرب غیر الکلی 50-18 سال
نمایه توده بدنی 40-27/5 کیلوگرم بر متر مربع
سطح فعالیت متوسط
زنان غیر یائسه مبتلا به کبد چرب غیر الکلی 50-18 سال نمایه توده بدنی 40-27/5 کیلوگرم بر متر مربع سطح فعالیت متوسط
pregnancy or lactation
alcohol consumption
smoking
anemia or thalassemia
other metabolic disorders
pregnancy or lactation alcohol consumption smoking anemia or thalassemia other metabolic disorders
بارداری یا شیردهی
مصرف الکل
سیگار کشیدن
آنمی یا تالاسمی
سایر بیماریهای متابولیکی
بارداری یا شیردهی مصرف الکل سیگار کشیدن آنمی یا تالاسمی سایر بیماریهای متابولیکی
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From among the patients who volunteer to participate in the study, 40 individuals will be selected by 4-blocks were randomly dهvided in 2 groups ( intervention and control) .
From among the patients who volunteer to participate in the study, 40 individuals will be selected by 4-blocks were randomly dهvided in 2 groups ( intervention and control) .
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از میان بیماران داوطلب شرکت در مطالعه، 40 نفر با استفاده از بلوک های 4 تایی به دو گروه 20 نفره مداخله و کنترل تقسیم بندی تصادفی شدند.
از میان بیماران داوطلب شرکت در مطالعه، 40 نفر با استفاده از بلوک های 4 تایی به دو گروه 20 نفره مداخله و کنترل تقسیم بندی تصادفی شدند.
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In this study, the main investigators (including the student, and her supervisor and adviser professors) as well as the patients will be blinded to the type of the supplement (HCA) received by each group.
In this study, the main investigators (including the student, and her supervisor and adviser professors) as well as the patients will be blinded to the type of the supplement (HCA) received by each group.
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در این مطالعه محققین اصلی (شامل دانشجو و اساتید راهنما و مشاور) و نیز بیماران از نوع مکمل دریافتی (HCA) توسط بی اطلاع خواهند بود.
در این مطالعه محققین اصلی (شامل دانشجو و اساتید راهنما و مشاور) و نیز بیماران از نوع مکمل دریافتی (HCA) توسط بی اطلاع خواهند بود.
Primary outcomes
#1
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Fasting ferritin
Fasting ferritin
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فریتین ناشتا
فریتین ناشتا
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At the baseline and at the end of intervention
At the baseline and at the end of intervention
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ابتدا و انتها مطالعه
ابتدا و انتها مطالعه
empty
ELIZA Kit
ELIZA Kit
empty
کیت الایزا
کیت الایزا
#2
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Glycated Hemoglobin
Glycated Hemoglobin
empty
هموگلوبین گلیکوزیله
هموگلوبین گلیکوزیله
empty
At the baseline and at the end of intervention
At the baseline and at the end of intervention
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ابتدا و انتها مطالعه
ابتدا و انتها مطالعه
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High Performance Liquid Chromatography (HPLC)
High Performance Liquid Chromatography (HPLC)
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کروماتوگرافی مایع با کارایی بالا
کروماتوگرافی مایع با کارایی بالا
#3
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Leptin
Leptin
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لپتین
لپتین
empty
At the baseline and at the end of intervention
At the baseline and at the end of intervention
empty
ابتدا و انتها مطالعه
ابتدا و انتها مطالعه
empty
ELIZA Kit
ELIZA Kit
empty
کیت الایزا
کیت الایزا
#4
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Adiponectin
Adiponectin
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آدیپونکتین
آدیپونکتین
empty
At the baseline and at the end of intervention
At the baseline and at the end of intervention
empty
ابتدا و انتها مطالعه
ابتدا و انتها مطالعه
empty
ELIZA Kit
ELIZA Kit
empty
کیت الایزا
کیت الایزا
#5
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Lipid profile ( HDL-C, TG,TC)
Lipid profile ( HDL-C, TG,TC)
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الگوی لیپیدی ( اچ دی ال کلسترول، تری گلیسرید، توتال کلسترول)
الگوی لیپیدی ( اچ دی ال کلسترول، تری گلیسرید، توتال کلسترول)
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At the baseline and at the end of intervention
At the baseline and at the end of intervention
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ابتدا و انتها مطالعه
ابتدا و انتها مطالعه
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Enzymetic
Enzymetic
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آنزیماتیک
آنزیماتیک
#6
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Interleukin-1 beta (IL-1β)
Interleukin-1 beta (IL-1β)
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اینترلوکین 1 بتا
اینترلوکین 1 بتا
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At the baseline and at the end of intervention
At the baseline and at the end of intervention
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ابتدا و انتها مطالعه
ابتدا و انتها مطالعه
empty
ELIZA Kit
ELIZA Kit
empty
کیت الایزا
کیت الایزا
#7
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Interleukin- 6
Interleukin- 6
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اینترلوکین 6
اینترلوکین 6
empty
At the baseline and at the end of intervention
At the baseline and at the end of intervention
empty
ابتدا و انتها مطالعه
ابتدا و انتها مطالعه
empty
ELIZA Kit
ELIZA Kit
empty
کیت الایزا
کیت الایزا
#8
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Tumor Necrosis Factor (TNF-a)
Tumor Necrosis Factor (TNF-a)
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فاکتور نکروز دهنده توموری
فاکتور نکروز دهنده توموری
empty
At the baseline and at the end of intervention
At the baseline and at the end of intervention
empty
ابتدا و انتها مطالعه
ابتدا و انتها مطالعه
empty
ELIZA Kit
ELIZA Kit
empty
کیت الایزا
کیت الایزا
Recruitment centers
#1
Name of recruitment center - English: Seikholrais Clinic
Name of recruitment center - Persian: کلینیک شیخ الرئیس
Full name of responsible person - English: Dr. Mehrangiz Ebrahimimamagani
Full name of responsible person - Persian: دکتر مهرانگیز ابراهیمی ممقانی
Street address - English: Azadi street
Street address - Persian: خیابان آزادی
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Sheikholrais Clinic
Name of recruitment center - Persian: کلینیک شیخ الرئیس
Full name of responsible person - English: Dr. Mehrangiz Ebrahimimamagani
Full name of responsible person - Persian: دکتر مهرانگیز ابراهیمی ممقانی
Street address - English: Azadi street
Street address - Persian: خیابان آزادی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5185747731
Phone: +98 41 3335 7582
Fax:
Email: solmaz.nomgolzari@yahoo.com
Web page address:
Name of recruitment center - English: SeikholraisSheikholrais Clinic Name of recruitment center - Persian: کلینیک شیخ الرئیس Full name of responsible person - English: Dr. Mehrangiz Ebrahimimamagani Full name of responsible person - Persian: دکتر مهرانگیز ابراهیمی ممقانی Street address - English: Azadi street Street address - Persian: خیابان آزادی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5185747731 Phone: +98 41 3335 7582 Fax: Email: solmaz.nomgolzari@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice Chancellor for Research of Tabriz University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr. Mohammad-Reza Rashidi
Full name of responsible person - Persian: دکتر محمد رضا رشیدی
Street address - English: Golgasht street, Tabriz University Of Medical Sciences,No 2 central building,3rd floor-Vice Chancellor for Research of Tabriz University of Medical Sciences
Street address - Persian: خیابان گلگشت-دانشگاه علوم پزشکی تبریز- ساختمان مرکزی شماره 2 طبقه سوم-معاونت تحقیقات و فناوری
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mohammad-Reza Rashidi
Full name of responsible person - Persian: دکتر محمد رضا رشیدی
Street address - English: Golgasht street, Tabriz University Of Medical Sciences,No 2 central building,3rd floor-Vice Chancellor for Research of Tabriz University of Medical Sciences
Street address - Persian: خیابان گلگشت-دانشگاه علوم پزشکی تبریز- ساختمان مرکزی شماره 2 طبقه سوم-معاونت تحقیقات و فناوری
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5158747731
Phone: +98 41 3335 7582
Fax:
Email: solmaz.nomgolzari@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice Chancellor for Research of Tabriz University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Dr. Mohammad-Reza Rashidi Full name of responsible person - Persian: دکتر محمد رضا رشیدی Street address - English: Golgasht street, Tabriz University Of Medical Sciences,No 2 central building,3rd floor-Vice Chancellor for Research of Tabriz University of Medical Sciences Street address - Persian: خیابان گلگشت-دانشگاه علوم پزشکی تبریز- ساختمان مرکزی شماره 2 طبقه سوم-معاونت تحقیقات و فناوری City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5158747731 Phone: +98 41 3335 7582 Fax: Email: solmaz.nomgolzari@yahoo.com Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Vice Chancellor for Research of Tabriz University of Medical Sciences
Tabriz University of Medical Sciences
Vice Chancellor for Research of Tabriz University of Medical Sciences
معاونت پژوهشی دانشگاه علوم پزشکی تبریز
دانشگاه علوم پزشکی تبریز
معاونت پژوهشی دانشگاه علوم پزشکی تبریز
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Nutrition faculty,Tabriz university of medical science
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز- دانشکده تغذیه
Full name of responsible person - English: Dr. Mehrangiz Ebrahimimamagani
Full name of responsible person - Persian: دکتر مهرانگیز ابراهیمی ممقانی
Position - English: Ntrition Phd
Position - Persian: Phd تغذیه/همکار طرح
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Golgasht street ,Attar neyshaburi street, nutriton faculty
Street address - Persian: خیابان گلگشت - خیابان عطار نیشابوری-دانشکده تغذیه
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3334 1113
Mobile: 00
Fax:
Email: ebrahimimamagani@tbzmed.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Nutrition faculty,Tabriz university of medical science
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز- دانشکده تغذیه
Full name of responsible person - English: Dr. Mehrangiz Ebrahimimamagani
Full name of responsible person - Persian: دکتر مهرانگیز ابراهیمی ممقانی
Position - English: Ntrition Phd
Position - Persian: Phd تغذیه/همکار طرح
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Golgasht street ,Attar neyshaburi street, nutriton faculty
Street address - Persian: خیابان گلگشت - خیابان عطار نیشابوری-دانشکده تغذیه
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5185747731
Phone: +98 41 3334 1113
Mobile: +98 914 103 4898
Fax:
Email: ebrahimimamagani@tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Nutrition faculty,Tabriz university of medical science Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز- دانشکده تغذیه Full name of responsible person - English: Dr. Mehrangiz Ebrahimimamagani Full name of responsible person - Persian: دکتر مهرانگیز ابراهیمی ممقانی Position - English: Ntrition Phd Position - Persian: Phd تغذیه/همکار طرح Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Golgasht street ,Attar neyshaburi street, nutriton faculty Street address - Persian: خیابان گلگشت - خیابان عطار نیشابوری-دانشکده تغذیه City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5185747731 Phone: +98 41 3334 1113 Mobile: 00+98 914 103 4898 Fax: Email: ebrahimimamagani@tbzmed.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Tabriz university of medical science- nutrition faculty
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز- دانشکده تغذیه
Full name of responsible person - English: Dr. Mehrangiz Ebrahimimamagani
Full name of responsible person - Persian: دکتر مهرانگیز ابراهیمی ممقانی
Position - English: Nutrition Phd
Position - Persian: Phd تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Golgasht street,Attar neyshabori street,Tabriz university of medical science,Nutrition faculty
Street address - Persian: خیابان گلگشت- خیابان عطار نیشابوری- دانشگاه علوم پزشکی تبریز-دانشکده تغذیه
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3334 1113
Mobile: 00
Fax:
Email: ebrahimimamagani@tbzmed.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz university of medical science- nutrition faculty
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز- دانشکده تغذیه
Full name of responsible person - English: Dr. Mehrangiz Ebrahimimamagani
Full name of responsible person - Persian: دکتر مهرانگیز ابراهیمی ممقانی
Position - English: Nutrition Phd
Position - Persian: Phd تغذیه
Latest degree: phd
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Golgasht street,Attar neyshabori street,Tabriz university of medical science,Nutrition faculty
Street address - Persian: خیابان گلگشت- خیابان عطار نیشابوری- دانشگاه علوم پزشکی تبریز-دانشکده تغذیه
City - English: Tabriz
City - Persian: تبریز
Province: West Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5185747731
Phone: +98 41 3334 1113
Mobile: +91 41034898
Fax:
Email: ebrahimimamagani@tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz university of medical science- nutrition faculty Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز- دانشکده تغذیه Full name of responsible person - English: Dr. Mehrangiz Ebrahimimamagani Full name of responsible person - Persian: دکتر مهرانگیز ابراهیمی ممقانی Position - English: Nutrition Phd Position - Persian: Phd تغذیه Latest degree: phd Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Golgasht street,Attar neyshabori street,Tabriz university of medical science,Nutrition faculty Street address - Persian: خیابان گلگشت- خیابان عطار نیشابوری- دانشگاه علوم پزشکی تبریز-دانشکده تغذیه City - English: Tabriz City - Persian: تبریز Province: West Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5185747731 Phone: +98 41 3334 1113 Mobile: 00+91 41034898 Fax: Email: ebrahimimamagani@tbzmed.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Nutirition faculty of Tabriz university of medical science
Name of organization / entity - Persian: دانشکده تغذیه-دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Solmaz Nomi golzar
Full name of responsible person - Persian: سولماز نومی گلزار
Position - English: student of Master science study of health science nutrition
Position - Persian: دانشجوی کارشناسی ارشد علوم بهداشتی تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English:
Street address - Persian:
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: 0098
Mobile: +98 914 103 4898
Fax:
Email: solmaz.nomgolzari@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Nutirition faculty of Tabriz university of medical science
Name of organization / entity - Persian: دانشکده تغذیه-دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Solmaz Nomi golzar
Full name of responsible person - Persian: سولماز نومی گلزار
Position - English: student of Master science study of health science nutrition
Position - Persian: دانشجوی کارشناسی ارشد علوم بهداشتی تغذیه
Latest degree: bachelor
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nutrition faculty-Attar neyshabury Ave,Golgasht st
Street address - Persian: خیابان گلگشت خیابان عطار نیشابوری دانشکده تغذیه
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5185747731
Phone: +98 914 103 4898
Mobile: +98 914 103 4898
Fax:
Email: solmaz.nomgolzari@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Nutirition faculty of Tabriz university of medical science Name of organization / entity - Persian: دانشکده تغذیه-دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Solmaz Nomi golzar Full name of responsible person - Persian: سولماز نومی گلزار Position - English: student of Master science study of health science nutrition Position - Persian: دانشجوی کارشناسی ارشد علوم بهداشتی تغذیه Latest degree: bachelor Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Nutrition faculty-Attar neyshabury Ave,Golgasht st Street address - Persian: خیابان گلگشت خیابان عطار نیشابوری دانشکده تغذیه City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5185747731 Phone: 0098+98 914 103 4898 Mobile: +98 914 103 4898 Fax: Email: solmaz.nomgolzari@yahoo.com Web page address:
Sharing plan
undecided
undecided
yes
yes
yes
yes
yes
yes
yes
yes
undecided
undecided
undecided
undecided
empty
There is no further information
There is no further information
empty
اطلاعات بیشتری وجود ندارد.
اطلاعات بیشتری وجود ندارد.
empty
Data collected for the primary outcomes will be shared.
Data collected for the primary outcomes will be shared.
empty
اطلاعات مربوط به پیامد های اصلی به اشتراک گذاشته خواهد شد.
اطلاعات مربوط به پیامد های اصلی به اشتراک گذاشته خواهد شد.
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access starting 12 months after publication
access starting 12 months after publication
empty
شروع دوره دسترسی 12 ماه پس از چاپ نتایج
شروع دوره دسترسی 12 ماه پس از چاپ نتایج
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The data will only be available for people working in academic institutions.
The data will only be available for people working in academic institutions.
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داده ها تنها برای افراد مشغول در مؤسسات علمی در دسترس خواهد بود.
داده ها تنها برای افراد مشغول در مؤسسات علمی در دسترس خواهد بود.
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The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.
The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.
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داده های مطالعه حاضر تنها جهت مطالعات متاآنالیز در دسترس محققین دیگر قرار خواهند گرفت.
داده های مطالعه حاضر تنها جهت مطالعات متاآنالیز در دسترس محققین دیگر قرار خواهند گرفت.
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To access the required data, the researchers can contact Ms. Solmaz Nomi Golzar: email address: solmaz.nomgolzari@yahoo.com cellphone number: 0098 9141034898
To access the required data, the researchers can contact Ms. Solmaz Nomi Golzar: email address: solmaz.nomgolzari@yahoo.com cellphone number: 0098 9141034898
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برای دسترسی به داده های مورد نیاز، محققین می توانند با خانم سولماز نومی گلزار ارتباط برقرار نمایند: آدرس پست الکترونیک: solmaz.nomgolzari@yahoo.comشماره تلفن همراه: 9141034898 0098
برای دسترسی به داده های مورد نیاز، محققین می توانند با خانم سولماز نومی گلزار ارتباط برقرار نمایند: آدرس پست الکترونیک: solmaz.nomgolzari@yahoo.comشماره تلفن همراه: 9141034898 0098
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The applicant should provide a brief description of the aims and methods of his Meta-analysis. His request will be assessed by the researchers, and if all of them agree to the request, the requested data will be emailed to the applicant in an Excel file format. All these procedures will take no longer than 15 days.
The applicant should provide a brief description of the aims and methods of his Meta-analysis. His request will be assessed by the researchers, and if all of them agree to the request, the requested data will be emailed to the applicant in an Excel file format. All these procedures will take no longer than 15 days.
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متقاضی باید توضیح مختصری از اهداف و روش کار مطالعه متاآنالیز خود ارائه دهد. درخواست متقاضی توسط محققین مورد بررسی قرار گرفته و در صورت موافقت همگی آنها، داده های مورد درخواست از طریق ایمیل و در قالب فایل اکسل برای متقاضی ارسال خواهد شد. تمام این مراحل بیش از 15 روز طول نخواهد کشید.
متقاضی باید توضیح مختصری از اهداف و روش کار مطالعه متاآنالیز خود ارائه دهد. درخواست متقاضی توسط محققین مورد بررسی قرار گرفته و در صورت موافقت همگی آنها، داده های مورد درخواست از طریق ایمیل و در قالب فایل اکسل برای متقاضی ارسال خواهد شد. تمام این مراحل بیش از 15 روز طول نخواهد کشید.
Protocol summary
Study aim
The aim of the present study is to investigate the effects of a weight loss diet with or without Hydroxy citric acid supplementation on hepcidin level of serum and liver enzymes and sonographic image in obese women with Non Alcoholic Fatty Liver Disease .
Design
Single-blind randomized clinical trial
Settings and conduct
The study will be conducted in the Sheikh Alrais clinic of Tabriz University of Medical Sciences, and supplementation duration will be 8 weeks.Patients will be blinded to the supplement they will receive.
Participants/Inclusion and exclusion criteria
40 patients with non alcoholic fatty liver disease and BMI of 30-40 Kg/m2 will be included in the study. Pregnancy, lactation, and co-morbidity of other metabolic or anemia or thalassemia are among the exclusion criteria of the study.
Intervention groups
The subjects in both groups will receive a weight loss diet considering their dietary habits. Patients in the intervention group will get 6 HCA tablets (2 tablets before breakfast, lunch, dinner).
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences,
Expected recruitment start date
2015-08-01, 1394/05/10
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
2015-08-01, 1394/05/10
Actual recruitment end date
2015-12-01, 1394/09/10
Trial completion date
empty
Scientific title
The effect of weight loss diet with and without Hydroxy citric Acid supplement derived from Garcinia Cambogia on the serum hepcidin level and liver function in women with NAFLD: A randomized controlled clinical trial
Public title
The effect of Hydroxy citric acid on non alcoholic fatty liver disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
non-menopausal women with Non Alcoholic Fatty Liver Dieases 18-50 years
BMI=27/5-40 kg/m2
moderate activity level
Exclusion criteria:
pregnancy or lactation
alcohol consumption
smoking
anemia or thalassemia
other metabolic disorders
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
From among the patients who volunteer to participate in the study, 40 individuals will be selected by 4-blocks were randomly dهvided in 2 groups ( intervention and control) .
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the main investigators (including the student, and her supervisor and adviser professors) as well as the patients will be blinded to the type of the supplement (HCA) received by each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Golgasht street , Tabriz
City
Tariz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2015-07-06, 1394/04/15
Ethics committee reference number
TBZMED.REC.1394.324
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
fatty (change) of liver,not elsewhere classified
Primary outcomes
1
Description
serum level of hepcidin
Timepoint
at baseline,at the end of intervention
Method of measurement
ELIZA Kit
2
Description
liver enzymes( ALT,AST,ALP)
Timepoint
at baseline,at the end of intervention
Method of measurement
IFCC
3
Description
liver steatosis
Timepoint
at baseline,at the end of intervention
Method of measurement
liver sonography
4
Description
Added at 2017-02-13: high sensivity-C Reactive Protein
Timepoint
Added at 2017-02-13: At the baseline and at the end of intervention
Method of measurement
Added at 2017-02-13: immunoturbidometric
5
Description
Added at 2017-02-13: Fasting blood sugar
Timepoint
Added at 2017-02-13: At the baseline and at the end of intervention
Method of measurement
Added at 2017-02-13: Radioimmunoassay
6
Description
Added at 2017-02-13: Fasting insulin
Timepoint
Added at 2017-02-13: At the baseline and at the end of intervention
Method of measurement
Added at 2017-02-13: Radioimmunoassay
7
Description
Fasting ferritin
Timepoint
At the baseline and at the end of intervention
Method of measurement
ELIZA Kit
8
Description
Glycated Hemoglobin
Timepoint
At the baseline and at the end of intervention
Method of measurement
High Performance Liquid Chromatography (HPLC)
9
Description
Leptin
Timepoint
At the baseline and at the end of intervention
Method of measurement
ELIZA Kit
10
Description
Adiponectin
Timepoint
At the baseline and at the end of intervention
Method of measurement
ELIZA Kit
11
Description
Lipid profile ( HDL-C, TG,TC)
Timepoint
At the baseline and at the end of intervention
Method of measurement
Enzymetic
12
Description
Interleukin-1 beta (IL-1β)
Timepoint
At the baseline and at the end of intervention
Method of measurement
ELIZA Kit
13
Description
Interleukin- 6
Timepoint
At the baseline and at the end of intervention
Method of measurement
ELIZA Kit
14
Description
Tumor Necrosis Factor (TNF-a)
Timepoint
At the baseline and at the end of intervention
Method of measurement
ELIZA Kit
Secondary outcomes
1
Description
Anthropometry
Timepoint
at baseline and at the end of intervention
Method of measurement
scale,meter,bioelectrical impedance analyzer
2
Description
energy and nutrients intake
Timepoint
at baseline and at the end of intervention
Method of measurement
24- hour dietary recall
Intervention groups
1
Description
intervention group: weight loss diet plus 6 tablets (2 tablets 30 minutes before: breakfast- lunch - dinner) for 2 months
Category
Treatment - Drugs
2
Description
control group: just get weight loss diet for 2 months
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikholrais Clinic
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Street address
Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5185747731
Phone
+98 41 3335 7582
Email
solmaz.nomgolzari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Reza Rashidi
Street address
Golgasht street, Tabriz University Of Medical Sciences,No 2 central building,3rd floor-Vice Chancellor for Research of Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5158747731
Phone
+98 41 3335 7582
Email
solmaz.nomgolzari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Nutrition faculty,Tabriz university of medical science
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Position
Ntrition Phd
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street ,Attar neyshaburi street, nutriton faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5185747731
Phone
+98 41 3334 1113
Fax
Email
ebrahimimamagani@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical science- nutrition faculty
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Position
Nutrition Phd
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Golgasht street,Attar neyshabori street,Tabriz university of medical science,Nutrition faculty
City
Tabriz
Province
West Azarbaijan
Postal code
5185747731
Phone
+98 41 3334 1113
Fax
Email
ebrahimimamagani@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nutirition faculty of Tabriz university of medical science
Full name of responsible person
Solmaz Nomi golzar
Position
student of Master science study of health science nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition faculty-Attar neyshabury Ave,Golgasht st
City
Tabriz
Province
East Azarbaijan
Postal code
5185747731
Phone
+98 914 103 4898
Fax
Email
solmaz.nomgolzari@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
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
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
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
access starting 12 months after publication
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.
From where data/document is obtainable
To access the required data, the researchers can contact Ms. Solmaz Nomi Golzar: email address: solmaz.nomgolzari@yahoo.com cellphone number: 0098 9141034898
What processes are involved for a request to access data/document
The applicant should provide a brief description of the aims and methods of his Meta-analysis. His request will be assessed by the researchers, and if all of them agree to the request, the requested data will be emailed to the applicant in an Excel file format. All these procedures will take no longer than 15 days.