The effect of hydro-alcoholic extract of Portulaca Oleracea L. (purslane) on Liver enzymes, Glycemic status and lipid profile in non-alcoholic fatty liver disease: a randomized, double-blind clinical trial.
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Protocol summary
The aim of the present study is to evaluate the effect of hydro-alcoholic extract of purslane in patients with non-alcoholic fatty liver disease (NAFLD). In a 12-week randomized, double-blind, clinical trial, 88 patients will be assigned to take either purslane extract capsule (containing 300 mg purslane extract) or placebo capsule. The study will be explained to each subject, who signs an informed consent. Steatosis grade will be determined by ultrasonography once at the beginning of the study and at the end of week 12. Three 24-hour recalls will be taken at the beginning and at the end of the study, including two working days and one weekend day. Diets will be analyzed for calorie and nutrient composition. Patient’s adherence to the study will be monitored every 15 days using telephone contact. Fasting blood samples will be obtained at baseline and at the end of study. Fasting blood sugar, insulin, total cholesterol, triglyceride, HDL-C, LDL-C, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase, alkaline phosphatase, glutathione peroxidase, total bilirubin, adiponectine, NF-κB and NF-κB gene expression will be assessed by appropriate methods. The study protocol has been approved by ethics committee of Iran University of Medical Sciences.
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The aim of the present study is to evaluate the effect of hydro-alcoholic extract of purslane in patients with non-alcoholic fatty liver disease (NAFLD). In a 12-week randomized, double-blind, clinical trial, 88 patients will be assigned to take either purslane extract capsule (containing 300 mg purslane extract) or placebo capsule. The study will be explained to each subject, who signs an informed consent. Steatosis grade will be determined by ultrasonography once at the beginning of the study and at the end of week 12. Three 24-hour recalls will be taken at the beginning and at the end of the study, including two working days and one weekend day. Diets will be analyzed for calorie and nutrient composition. Patient’s adherence to the study will be monitored every 15 days using telephone contact. Fasting blood samples will be obtained at baseline and at the end of study. Fasting blood sugar, insulin, total cholesterol, triglyceride, HDL-C, LDL-C, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase, alkaline phosphatase, glutathione peroxidase, total bilirubin, adiponectine, NF-κB and NF-κB gene expression will be assessed by appropriate methods. The study protocol has been approved by ethics committee of Iran University of Medical Sciences.
هدف مطالعه حاضر، ارزيابي اثر عصاره هيدروالکلي خرفه در بيماران مبتلا به کبد چرب غير الکلي (NAFLD) مي باشد. در يک کارآزمايي باليني تصادفي شده دو سوکور 12 هفته اي، 88 بيمار به دو گروه دريافت کننده کپسول عصاره خرفه (حاوي 300 ميلي گرم عصاره خرفه) يا کپسول دارونما تقسيم مي شوند. مطالعه براي تک تک بيماران شرح و فرم رضايتنامه کتبي از بيماران اخذ خواهد شد. درجه استئاتوز کبدي با استفاده از اولتراسونوگرافي، يکبار در ابتدا و بار ديگر در هفته 12 مطالعه تعيين مي شود. سه روز يادآمد غذايي در آغاز و پايان مطالعه، شامل دو روز کاري و يک روز تعطيل، گرفته خواهد شد. رژيم غذايي بيماران براي تعيين کالري و ترکيب مواد مغذي آناليز مي شود. تبعيت بيماران از مطالعه با تماس تلفني هر 15 روز يکبار مورد پايش قرار مي گيرد. نمونه هاي خون ناشتا در ابتدا و انتهاي مطالعه از بيماران گرفته خواهد شد. قند خون ناشتا، انسولين، کلسترول تام، تري گليسيريد، HDL-C، LDL-C، آلانين آمينوترانسفراز، آسپارتات آمينوترانسفراز، گاما گلوتاميل ترانسفراز، آلکالين فسفاتاز، گلوتاتيون پراکسيداز، بيلي روبين تام، آديپونکتين، NF-κB و بيان ژن NF-κB با استفاده از روشهاي مناسب ارزيابي مي شوند. پروتکل مطالعه توسط کميته اخلاق دانشگاه علوم پزشکي ايران تصويب شده است.
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هدف مطالعه حاضر، ارزيابي اثر عصاره هيدروالکلي خرفه در بيماران مبتلا به کبد چرب غير الکلي (NAFLD) مي باشد. در يک کارآزمايي باليني تصادفي شده دو سوکور 12 هفته اي، 88 بيمار به دو گروه دريافت کننده کپسول عصاره خرفه (حاوي 300 ميلي گرم عصاره خرفه) يا کپسول دارونما تقسيم مي شوند. مطالعه براي تک تک بيماران شرح و فرم رضايتنامه کتبي از بيماران اخذ خواهد شد. درجه استئاتوز کبدي با استفاده از اولتراسونوگرافي، يکبار در ابتدا و بار ديگر در هفته 12 مطالعه تعيين مي شود. سه روز يادآمد غذايي در آغاز و پايان مطالعه، شامل دو روز کاري و يک روز تعطيل، گرفته خواهد شد. رژيم غذايي بيماران براي تعيين کالري و ترکيب مواد مغذي آناليز مي شود. تبعيت بيماران از مطالعه با تماس تلفني هر 15 روز يکبار مورد پايش قرار مي گيرد. نمونه هاي خون ناشتا در ابتدا و انتهاي مطالعه از بيماران گرفته خواهد شد. قند خون ناشتا، انسولين، کلسترول تام، تري گليسيريد، HDL-C، LDL-C، آلانين آمينوترانسفراز، آسپارتات آمينوترانسفراز، گاما گلوتاميل ترانسفراز، آلکالين فسفاتاز، گلوتاتيون پراکسيداز، بيلي روبين تام، آديپونکتين، NF-κB و بيان ژن NF-κB با استفاده از روشهاي مناسب ارزيابي مي شوند. پروتکل مطالعه توسط کميته اخلاق دانشگاه علوم پزشکي ايران تصويب شده است.
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The aim of this study was to evaluate the effect of portulaca oleracea (purslane) hydroalcoholic extract in patients with non-alcoholic fatty liver disease (NAFLD).
The aim of this study was to evaluate the effect of portulaca oleracea (purslane) hydroalcoholic extract in patients with non-alcoholic fatty liver disease (NAFLD).
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هدف مطالعه حاضر، ارزيابي اثر عصاره هيدروالکلي خرفه در بيماران مبتلا به کبد چرب غير الکلي (NAFLD) مي باشد.
هدف مطالعه حاضر، ارزيابي اثر عصاره هيدروالکلي خرفه در بيماران مبتلا به کبد چرب غير الکلي (NAFLD) مي باشد.
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A 12-week randomized, double-blinded, parallel clinical trial on 74 patients with NAFLD.
A 12-week randomized, double-blinded, parallel clinical trial on 74 patients with NAFLD.
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کارآزمایی بالینی موازی تصادفی شده دو سوکور 12 هفته ای بر روی 74 بیمار مبتلا به کبد چرب غیر الکلی
کارآزمایی بالینی موازی تصادفی شده دو سوکور 12 هفته ای بر روی 74 بیمار مبتلا به کبد چرب غیر الکلی
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Patients are randomly divided into intervention and placebo groups (37 patients in each group). The study process is described for each patient and a written consent form is obtained from the patients. The degree of hepatic steatosis is determined using ultrasound once at the beginning and again at week 12 of the study. The 3-day of 24-hour dietary recall is taken at the beginning and end of the study. A diet for 10% weight loss will be provided to each patients individually by a nutritionist. Patients' compliance is monitored by telephone every 15 days. Fasting blood samples are taken from patients at the beginning and at end of the study. The study protocol has been approved by the ethics committee of Iran University of Medical Sciences.
Patients are randomly divided into intervention and placebo groups (37 patients in each group). The study process is described for each patient and a written consent form is obtained from the patients. The degree of hepatic steatosis is determined using ultrasound once at the beginning and again at week 12 of the study. The 3-day of 24-hour dietary recall is taken at the beginning and end of the study. A diet for 10% weight loss will be provided to each patients individually by a nutritionist. Patients' compliance is monitored by telephone every 15 days. Fasting blood samples are taken from patients at the beginning and at end of the study. The study protocol has been approved by the ethics committee of Iran University of Medical Sciences.
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بیماران بطور تصادفی به دو گروه مداخله و دارونما تقسیم می شوند (37 بیمار در هر گروه). فرایند مطالعه براي تک تک بيماران شرح داده و فرم رضايتنامه کتبي از بيماران اخذ می گردد. درجه استئاتوز کبدي با استفاده از اولتراسونوگرافي، يکبار در ابتدا و بار ديگر در هفته 12 مطالعه تعيين مي شود. سه روز يادآمد غذايي در آغاز و پايان مطالعه گرفته مي شود. رژیم غذایی با هدف 10% کاهش وزن توسط متخصص تغذیه برای همه بیماران تنظیم می گردد. تبعيت بيماران از مطالعه با تماس تلفني هر 15 روز يکبار مورد پايش قرار مي گيرد. در ابتدا و انتهاي مطالعه، نمونه هاي خون ناشتا از بيماران گرفته می شود. پروتکل مطالعه توسط کميته اخلاق دانشگاه علوم پزشکي ايران تصويب شده است.
بیماران بطور تصادفی به دو گروه مداخله و دارونما تقسیم می شوند (37 بیمار در هر گروه). فرایند مطالعه براي تک تک بيماران شرح داده و فرم رضايتنامه کتبي از بيماران اخذ می گردد. درجه استئاتوز کبدي با استفاده از اولتراسونوگرافي، يکبار در ابتدا و بار ديگر در هفته 12 مطالعه تعيين مي شود. سه روز يادآمد غذايي در آغاز و پايان مطالعه گرفته مي شود. رژیم غذایی با هدف 10% کاهش وزن توسط متخصص تغذیه برای همه بیماران تنظیم می گردد. تبعيت بيماران از مطالعه با تماس تلفني هر 15 روز يکبار مورد پايش قرار مي گيرد. در ابتدا و انتهاي مطالعه، نمونه هاي خون ناشتا از بيماران گرفته می شود. پروتکل مطالعه توسط کميته اخلاق دانشگاه علوم پزشکي ايران تصويب شده است.
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Men and women with non-alcoholic fatty liver disease whose ALT is greater than 30 U / l and more than 19 U / L, respectively, and who do not have chronic liver disease, cardiovascular disease, hypertension, or kidney stones are eligible to participate in the study.
Men and women with non-alcoholic fatty liver disease whose ALT is greater than 30 U / l and more than 19 U / L, respectively, and who do not have chronic liver disease, cardiovascular disease, hypertension, or kidney stones are eligible to participate in the study.
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مردان و زنان مبتلا به کبد چرب غیر الکلی که ALT آنها به ترتیب بيشتر از 30 U/l و بيشتر از U/L 19 بوده و فاقد بیماریهای کبدی مزمن، قلبی عروقی، پرفشاری خون و سنگهای کلیوی می باشند واجد شرکت در مطالعه هستند.
مردان و زنان مبتلا به کبد چرب غیر الکلی که ALT آنها به ترتیب بيشتر از 30 U/l و بيشتر از U/L 19 بوده و فاقد بیماریهای کبدی مزمن، قلبی عروقی، پرفشاری خون و سنگهای کلیوی می باشند واجد شرکت در مطالعه هستند.
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Intervention group: one capsule containing 300 mg of purslane hydroalcoholic extract daily.
Placebo Group: A capsule daily similar in appearance to drug capsules, filled with toasted powder.
Intervention group: one capsule containing 300 mg of purslane hydroalcoholic extract daily. Placebo Group: A capsule daily similar in appearance to drug capsules, filled with toasted powder.
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گروه مداخله: روزانه یک عدد کپسول حاوی 300 میلی گرم عصاره هیدروالکلی خرفه.
گروه دارونما: روزانه یک کپسول با ظاهر مشابه کپسولهای دارو، پر شده با پودر سوخاری.
گروه مداخله: روزانه یک عدد کپسول حاوی 300 میلی گرم عصاره هیدروالکلی خرفه. گروه دارونما: روزانه یک کپسول با ظاهر مشابه کپسولهای دارو، پر شده با پودر سوخاری.
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Serum levels of ALT and AST are the main outcomes of the study. Other variables include fasting blood glucose, insulin, total cholesterol, triglycerides, HDL-C, LDL-C, gamma glutamyl transferase, alkaline phosphatase, glutathione peroxidase, total bilirubin, adiponectin, NF-kB and expression of the NF-κB gene.
Serum levels of ALT and AST are the main outcomes of the study. Other variables include fasting blood glucose, insulin, total cholesterol, triglycerides, HDL-C, LDL-C, gamma glutamyl transferase, alkaline phosphatase, glutathione peroxidase, total bilirubin, adiponectin, NF-kB and expression of the NF-κB gene.
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سطوح سرمی ALT و AST متغیرهای اصلی مطالعه هستند. سایر متغیرها عبارتند از: قند خون ناشتا، انسولين، کلسترول تام، تري گليسيريد، HDL-C، LDL-C، گاما گلوتاميل ترانسفراز، آلکالين فسفاتاز، گلوتاتيون پراکسيداز، بيلي روبين تام، آديپونکتين، NF-κB و بيان ژن NF-κB
سطوح سرمی ALT و AST متغیرهای اصلی مطالعه هستند. سایر متغیرها عبارتند از: قند خون ناشتا، انسولين، کلسترول تام، تري گليسيريد، HDL-C، LDL-C، گاما گلوتاميل ترانسفراز، آلکالين فسفاتاز، گلوتاتيون پراکسيداز، بيلي روبين تام، آديپونکتين، NF-κB و بيان ژن NF-κB
General information
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1. Submission of information in the old version of IRCT
2. Creating some changes in the sample size after the approval of the Vice Chancellor for Research of Iran University of Medical Sciences
3. Correcting the secondary outcome variables
1. Submission of information in the old version of IRCT 2. Creating some changes in the sample size after the approval of the Vice Chancellor for Research of Iran University of Medical Sciences 3. Correcting the secondary outcome variables
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1. ثبت اطلاعات در نسخه قدیمی IRCT
2. ایجاد بعضی تغییرات در حجم نمونه پس از موافقت معاونت پژوهشی دانشگاه علوم پزشکی ایران
3. تصحیح نگارش متغیرهای پیامد ثانویه
1. ثبت اطلاعات در نسخه قدیمی IRCT 2. ایجاد بعضی تغییرات در حجم نمونه پس از موافقت معاونت پژوهشی دانشگاه علوم پزشکی ایران 3. تصحیح نگارش متغیرهای پیامد ثانویه
The effect of hydro-alcoholic extract of Portulaca Oleracea L. (purslane) on Liver enzymes, Glycemic status, lipid pforile, Gluathione peroxidase activity, Adiponectin, NF-κB, and NF-κB gene expression in non-alcoholic fatty liver disease: a randomized, double-blind clinial trial.
The effect of hydro-alcoholic extract of Portulaca Oleracea L. (purslane) on Liver enzymes, Glycemic status and lipid profile in non-alcoholic fatty liver disease: a randomized, double-blind clinical trial.
The effect of hydro-alcoholic extract of Portulaca Oleracea L. (purslane) on Liver enzymes, Glycemic status, and lipid pforile, Gluathione peroxidase activity, Adiponectin, NF-κB, and NF-κB gene expressionprofile in non-alcoholic fatty liver disease: a randomized, double-blind clinialclinical trial.
اثر مصرف عصاره هيدروالکلي گياه خرفه بر آنزيمهاي کبدي، وضعیت گلایسمیک، پروفايل ليپيدي، فعالیت گلوتاتيون پراکسيداز، آديپونکتين، NF-κB و بيان ژن NF-κB در افراد مبتلا به کبد چرب غیر الکلی: کارآزمايي باليني تصادفي شده دوسوکور
اثر مصرف عصاره هيدروالکلي گياه خرفه بر آنزيمهاي کبدي، وضعیت گلایسمیک و پروفايل ليپيدي در افراد مبتلا به کبد چرب غیر الکلی: کارآزمايي باليني تصادفي شده دوسوکور
اثر مصرف عصاره هيدروالکلي گياه خرفه بر آنزيمهاي کبدي، وضعیت گلایسمیک، و پروفايل ليپيدي، فعالیت گلوتاتيون پراکسيداز، آديپونکتين، NF-κB و بيان ژن NF-κB در افراد مبتلا به کبد چرب غیر الکلی: کارآزمايي باليني تصادفي شده دوسوکور
Being volunteer or Wishing to attend
Age 18 years or older
Alanine aminotransferase (ALT) greater than 19 IU/L for women and greater than 30 IU/L for men
Evidence of fatty liver in ultrasonography with a score of 1 or more
BMI ≥ 25 kg/m2
Being volunteer or Wishing to attend Age 18 years or older Alanine aminotransferase (ALT) greater than 19 IU/L for women and greater than 30 IU/L for men Evidence of fatty liver in ultrasonography with a score of 1 or more BMI ≥ 25 kg/m2
تمایل به شرکت در مطالعه
سن 18 سال به بالا
سطوح سرمي آنزيم کبدي (ALT بيشتر از 19 U/l براي زنان و بيشتر از U/L 30 براي مردان)
درجه استئاتوز کبدي يک و بالاتر در اولتراسونوگرافي بيماران
BMI ≥ از 25 kg/m2
تمایل به شرکت در مطالعه سن 18 سال به بالا سطوح سرمي آنزيم کبدي (ALT بيشتر از 19 U/l براي زنان و بيشتر از U/L 30 براي مردان) درجه استئاتوز کبدي يک و بالاتر در اولتراسونوگرافي بيماران BMI ≥ از 25 kg/m2
Other acute or chronic hepatic disorders (hepatitis B or C)
Biliary diseases
Cancer
Hypertension
History of cardiovascular disease
Nephrolithiasis (oxalate stones) or history of oxalate stones
Consumption of omega-3 and vitamin E supplement
Alcohol use
Use of hepatotoxic medications during last month
Changing medication dosage during the study
Pregnancy
Lactation
Compliacne less than 80%
Other acute or chronic hepatic disorders (hepatitis B or C) Biliary diseases Cancer Hypertension History of cardiovascular disease Nephrolithiasis (oxalate stones) or history of oxalate stones Consumption of omega-3 and vitamin E supplement Alcohol use Use of hepatotoxic medications during last month Changing medication dosage during the study Pregnancy Lactation Compliacne less than 80%
ابتلا به ساير بيماريها و اختلالات مزمن و حاد کبدي (هپاتيت B، C)
ابتلا به بيماريهاي صفراوي
ابتلا به سرطان
ابتلا به پرفشاری خون
سابقه بیماری های قلبی- عروقی
ابتلا به سنگ کليه از نوع اگزالاتي يا سابقه وجود سنگ کليه اگزالاتي
مصرف مکملهاي امگا-3 و ويتامين E
مصرف الکل
مصرف داروهاي هپاتوتوکسيک طي يک ماه گذشته
تغيير در دوز داروهاي مصرفي در طول مطالعه
بارداری
شیردهی
کمپليانس کمتر از 80%
ابتلا به ساير بيماريها و اختلالات مزمن و حاد کبدي (هپاتيت B، C) ابتلا به بيماريهاي صفراوي ابتلا به سرطان ابتلا به پرفشاری خون سابقه بیماری های قلبی- عروقی ابتلا به سنگ کليه از نوع اگزالاتي يا سابقه وجود سنگ کليه اگزالاتي مصرف مکملهاي امگا-3 و ويتامين E مصرف الکل مصرف داروهاي هپاتوتوکسيک طي يک ماه گذشته تغيير در دوز داروهاي مصرفي در طول مطالعه بارداری شیردهی کمپليانس کمتر از 80%
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Block randomization method has been used for randomization. Blocks of size 4 are generated using www.sealedenvelope.com. In order to conceal in the randomization process, unique codes have been used on the medicine boxes, which are produced by the software.
Block randomization method has been used for randomization. Blocks of size 4 are generated using www.sealedenvelope.com. In order to conceal in the randomization process, unique codes have been used on the medicine boxes, which are produced by the software.
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برای تصادفی سازی از روش بلوکهای تصادفی استفاده شده است.بلوکهای چهارتایی با استفاده از سایت www.sealedenvelope.com تولید شده اند. به منظور اعمال پنهان سازی یا concealment در فرایند تصادفی سازی از کدهای منحصر به فرد بر روی جعبه های دارویی استفاده شده است که این کدها توسط نرم افزار تولید شده اند.
برای تصادفی سازی از روش بلوکهای تصادفی استفاده شده است.بلوکهای چهارتایی با استفاده از سایت www.sealedenvelope.com تولید شده اند. به منظور اعمال پنهان سازی یا concealment در فرایند تصادفی سازی از کدهای منحصر به فرد بر روی جعبه های دارویی استفاده شده است که این کدها توسط نرم افزار تولید شده اند.
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In order to apply concealment in the randomization process, unique codes will be used on the medicine boxes, and the desired code will also be produced by the software.
In order to apply concealment in the randomization process, unique codes will be used on the medicine boxes, and the desired code will also be produced by the software.
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به منظور اعمال پنهان سازی در فرآیند تصادفی سازی از کدهای منحصر به فرد بر روی جعبه های دارویی استفاده خواهد شد که کد مورد نظر نیز توسط نرم افزار تولید می شود
به منظور اعمال پنهان سازی در فرآیند تصادفی سازی از کدهای منحصر به فرد بر روی جعبه های دارویی استفاده خواهد شد که کد مورد نظر نیز توسط نرم افزار تولید می شود
88 subjects
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88 subjects
88 نفر
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88 نفر
Primary outcomes
#1
Laboratory kit (U/L)
Laboratory kit
Laboratory kit (U/L)
کيت آزمايشگاهي (U/L)
کيت آزمايشگاهي
کيت آزمايشگاهي (U/L)
#2
Laboratory kit (U/L)
Laboratory kit
Laboratory kit (U/L)
کيت آزمايشگاهي (U/L)
کيت آزمايشگاهي
کيت آزمايشگاهي (U/L)
Secondary outcomes
#1
Glutathione peroxidase (GPX)
Weight
Glutathione peroxidase (GPX)Weight
گلوتاتيون پراکسيداز (GPX)
وزن
گلوتاتيون پراکسيداز (GPX)وزن
Laboratory kit (U/g Hb)
Seca scale
Laboratory kit (U/g Hb)Seca scale
کيت آزمايشگاهي (U/g Hb)
ترازوی Seca
کيت آزمايشگاهي (U/g Hb)ترازوی Seca
#2
NF-κB
Body mass index (BMI)
NF-κBBody mass index (BMI)
NF-κB
نمایه توده بدن
NF-κBنمایه توده بدن
Laboratory kit (ELISA method)
Calculation: weight (in kilograms) divided by the square of height (in meters)
Laboratory kitCalculation: weight (ELISA methodin kilograms) divided by the square of height (in meters)
کيت آزمايشگاهي (با روش ELISA)
محاسبه: وزن (کیلوگرم) تقسیم بر قد (متر مربع)
کيت آزمايشگاهيمحاسبه: وزن (با روش ELISAکیلوگرم) تقسیم بر قد (متر مربع)
#3
Adiponectin
Waist circumference
AdiponectinWaist circumference
آديپونکتين
دور کمر
آديپونکتيندور کمر
At the begining and at the end of week 12
At the beginning and at the end of week 12
At the beginingbeginning and at the end of week 12
Name of recruitment center - English: Rasoul akram Hospital
Name of recruitment center - Persian: بيمارستان رسول اکرم
Full name of responsible person - English: Dr. Shahram Agah
Full name of responsible person - Persian: دکتر شهرام آگاه
Street address - English: Niayesh St., Sattarkhan Ave., Rasoul akram Hospital.
Street address - Persian: خيابان ستارخان، خيابان نيايش، بيمارستان رسول اکرم
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Rasoul akram Hospital
Name of recruitment center - Persian: بيمارستان رسول اکرم
Full name of responsible person - English: Dr. Shahram Agah
Full name of responsible person - Persian: دکتر شهرام آگاه
Street address - English: Niayesh St., Sattarkhan Ave., Rasoul akram Hospital.
Street address - Persian: خيابان ستارخان، خيابان نيايش، بيمارستان رسول اکرم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6435 1000
Fax:
Email: hrmc@iums.ac.ir
Web page address: https://hrmc.iums.ac.ir/
Name of recruitment center - English: Rasoul akram Hospital Name of recruitment center - Persian: بيمارستان رسول اکرم Full name of responsible person - English: Dr. Shahram Agah Full name of responsible person - Persian: دکتر شهرام آگاه Street address - English: Niayesh St., Sattarkhan Ave., Rasoul akram Hospital. Street address - Persian: خيابان ستارخان، خيابان نيايش، بيمارستان رسول اکرم City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 6435 1000 Fax: Email: hrmc@iums.ac.ir Web page address: https://hrmc.iums.ac.ir/
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice Chancellor for Research of Iran university Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Dr. Seyyed Ali Javad Mousavi, deputy head of Research and Technology, Iran University of Medical Sci
Full name of responsible person - Persian: دکتر سید علی جواد موسوی ،معاون تحقیقات و فناوری، دانشگاه علوم پزشکی ایران
Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway.
Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
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. Seyyed Abbas Motevallian, deputy head of Research and Technology, Iran University of Medical Sci
Full name of responsible person - Persian: دکتر سید عباس متولیان ،معاون تحقیقات و فناوری، دانشگاه علوم پزشکی ایران
Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway.
Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 8670 2504
Fax:
Email: research-m@iums.ac.ir
Web page address: https://vcr.iums.ac.ir
contact.organization_id: Name of organization / entity - English: Vice Chancellor for Research of Iran university Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران Full name of responsible person - English: Dr. Seyyed Ali Javad MousaviAbbas Motevallian, deputy head of Research and Technology, Iran University of Medical Sci Full name of responsible person - Persian: دکتر سید علی جواد موسویعباس متولیان ،معاون تحقیقات و فناوری، دانشگاه علوم پزشکی ایران Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway. Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 21 8670 2504 Fax: Email: research-m@iums.ac.ir Web page address: https://vcr.iums.ac.ir
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Public
public
empty
Domestic
domestic
empty
Academic
academic
Vice Chancellor for Research of Iran university Medical Sciences
Iran University of Medical Sciences
Vice Chancellor for ResearchIran University of Iran university Medical Sciences
معاونت پژوهشی دانشگاه علوم پزشکی ایران
دانشگاه علوم پزشکی ایران
معاونت پژوهشی دانشگاه علوم پزشکی ایران
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: School of Health, Iran University of Medical Sciences
Name of organization / entity - Persian: دانشکده بهداشت، دانشگاه علوم پزشکي ايران
Full name of responsible person - English: Dr. Farzad Shidfar
Full name of responsible person - Persian: دکتر فرزاد شيدفر
Position - English: Full Professor
Position - Persian: استاد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway.
Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: 00982188607941- 00982188607945
Mobile: +98 912 308 2922
Fax: +98 21 8862 2707
Email: Farzadshidfar@yahoo.com; Shidfar.f@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Farzad Shidfar
Full name of responsible person - Persian: دکتر فرزاد شيدفر
Position - English: Full Professor
Position - Persian: استاد
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway.
Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: 00982188607941- 00982188607945
Mobile: +98 912 308 2922
Fax: +98 21 8862 2707
Email: Shidfar.f@iums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: School of Health, Iran University of Medical Sciences Name of organization / entity - Persian: دانشکده بهداشت، دانشگاه علوم پزشکي ايران Full name of responsible person - English: Dr. Farzad Shidfar Full name of responsible person - Persian: دکتر فرزاد شيدفر Position - English: Full Professor Position - Persian: استاد Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway. Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: 00982188607941- 00982188607945 Mobile: +98 912 308 2922 Fax: +98 21 8862 2707 Email: Farzadshidfar@yahoo.com; Shidfar.f@iums.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Iran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکي ايران
Full name of responsible person - English: Dr. Farzad Shidfar
Full name of responsible person - Persian: دکتر فرزاد شيدفر
Position - English: PhD of Nutrition
Position - Persian: دکتراي تخصصي تغذيه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Health, Iran University of Medical Sciences, Shahid Hemmat Highway.
Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران، دانشکده بهداشت
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8860 7945
Mobile: +98 912 308 2922
Fax: +98 21 8862 2707
Email: Farzadshidfar@yahoo.com; Shidfar.f@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Farzad Shidfar
Full name of responsible person - Persian: دکتر فرزاد شيدفر
Position - English: PhD of Nutrition
Position - Persian: دکتراي تخصصي تغذيه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Health, Iran University of Medical Sciences, Shahid Hemmat Highway.
Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران، دانشکده بهداشت
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8860 7945
Mobile: +98 912 308 2922
Fax: +98 21 8862 2707
Email: Farzadshidfar@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Iran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکي ايران Full name of responsible person - English: Dr. Farzad Shidfar Full name of responsible person - Persian: دکتر فرزاد شيدفر Position - English: PhD of Nutrition Position - Persian: دکتراي تخصصي تغذيه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Health, Iran University of Medical Sciences, Shahid Hemmat Highway. Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران، دانشکده بهداشت City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 8860 7945 Mobile: +98 912 308 2922 Fax: +98 21 8862 2707 Email: Farzadshidfar@yahoo.com; Shidfar.f@iums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Iran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکي ايران
Full name of responsible person - English: Dr. Farzad Shidfar
Full name of responsible person - Persian: دکتر فرزاد شيدفر
Position - English: PhD of Nutrition, Full Professor
Position - Persian: دکتراي تخصصي تغذيه، استاد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Health, Iran University of Medical Sciences, Shahid Hemmat Highway.
Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران، دانشکده بهداشت
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8860 7945
Mobile: +98 912 308 2922
Fax: +98 21 8862 2707
Email: Farzadshidfar@yahoo.com; Shidfar.f@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Farzad Shidfar
Full name of responsible person - Persian: دکتر فرزاد شيدفر
Position - English: PhD of Nutrition, Full Professor
Position - Persian: دکتراي تخصصي تغذيه، استاد
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Health, Iran University of Medical Sciences, Shahid Hemmat Highway.
Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران، دانشکده بهداشت
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8860 7945
Mobile: +98 912 308 2922
Fax: +98 21 8862 2707
Email: Farzadshidfar@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Iran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکي ايران Full name of responsible person - English: Dr. Farzad Shidfar Full name of responsible person - Persian: دکتر فرزاد شيدفر Position - English: PhD of Nutrition, Full Professor Position - Persian: دکتراي تخصصي تغذيه، استاد Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Health, Iran University of Medical Sciences, Shahid Hemmat Highway. Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران، دانشکده بهداشت City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 8860 7945 Mobile: +98 912 308 2922 Fax: +98 21 8862 2707 Email: Farzadshidfar@yahoo.com; Shidfar.f@iums.ac.ir Web page address:
Sharing plan
no
no
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
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There is no further information
There is no further information
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اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
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Information on the main outcomes at the end of the study can be shared.
Information on the main outcomes at the end of the study can be shared.
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اطلاعات مربوط به پیامدهای اصلی در انتهای مطالعه می تواند به اشتراک گذارده شود.
اطلاعات مربوط به پیامدهای اصلی در انتهای مطالعه می تواند به اشتراک گذارده شود.
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The access period will be 6 months after the publication of the results.
The access period will be 6 months after the publication of the results.
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دوره دسترسی 6 ماه پس از چاپ نتایج خواهد بود.
دوره دسترسی 6 ماه پس از چاپ نتایج خواهد بود.
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The data from this study will only be available to researchers working at academic and scientific institutions.
The data from this study will only be available to researchers working at academic and scientific institutions.
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داده های حاصل از این مطالعه فقط برای محققین شاغل در موسسات دانشگاهی و علمی در دسترس خواهد بود.
داده های حاصل از این مطالعه فقط برای محققین شاغل در موسسات دانشگاهی و علمی در دسترس خواهد بود.
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Six months after the publication of the articles of this project, upon request from the corresponding author and his agreement, the study data can be made available to researchers.
Six months after the publication of the articles of this project, upon request from the corresponding author and his agreement, the study data can be made available to researchers.
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۶ ماه پس از چاپ مقالات حاصل از داده های این طرح، با درخواست از مسئول طرح و موافقت ایشان، داده های مطالعه می تواند در دسترس محققین قرار گیرد.
۶ ماه پس از چاپ مقالات حاصل از داده های این طرح، با درخواست از مسئول طرح و موافقت ایشان، داده های مطالعه می تواند در دسترس محققین قرار گیرد.
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Applicants can contact the corresponding author via email or the following postal address to receive the required data. Nutrition department, School of health, Iran University of Medical Sciences, Hemmat highsway, Tehran Phon number:0098 21 8862 2755 E-mail: Farzadshidfar@yahoo.com
Applicants can contact the corresponding author via email or the following postal address to receive the required data. Nutrition department, School of health, Iran University of Medical Sciences, Hemmat highsway, Tehran Phon number:0098 21 8862 2755 E-mail: Farzadshidfar@yahoo.com
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متقاضیان برای دریافت داده های مورد نظر می توانند از طریق ایمیل یا آدرس پستی زیر با نویسنده مسئول مکاتبه کنند. آدرس پستی: تهران، بزرگراه همت، دانشگاه علوم پزشکی ایران، دانشکده بهداشت، گروه تغذیه شماره تلفن: 0098 21 8862 2755 ایمیل: Farzadshidfar@yahoo.com
متقاضیان برای دریافت داده های مورد نظر می توانند از طریق ایمیل یا آدرس پستی زیر با نویسنده مسئول مکاتبه کنند. آدرس پستی: تهران، بزرگراه همت، دانشگاه علوم پزشکی ایران، دانشکده بهداشت، گروه تغذیه شماره تلفن: 0098 21 8862 2755 ایمیل: Farzadshidfar@yahoo.com
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Applicants will be able to access the data from the present study no later than one week by sending an email to the corresponding author.
Applicants will be able to access the data from the present study no later than one week by sending an email to the corresponding author.
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متقاضیان از طریق ارسال ایمیل به نویسنده مسئول، حداکثر پس از گذشت یک هفته، قادر خواهند بود به داده های حاصل از مطالعه حاضر دسترسی داشته باشند.
متقاضیان از طریق ارسال ایمیل به نویسنده مسئول، حداکثر پس از گذشت یک هفته، قادر خواهند بود به داده های حاصل از مطالعه حاضر دسترسی داشته باشند.
Protocol summary
Study aim
The aim of this study was to evaluate the effect of portulaca oleracea (purslane) hydroalcoholic extract in patients with non-alcoholic fatty liver disease (NAFLD).
Design
A 12-week randomized, double-blinded, parallel clinical trial on 74 patients with NAFLD.
Settings and conduct
Patients are randomly divided into intervention and placebo groups (37 patients in each group). The study process is described for each patient and a written consent form is obtained from the patients. The degree of hepatic steatosis is determined using ultrasound once at the beginning and again at week 12 of the study. The 3-day of 24-hour dietary recall is taken at the beginning and end of the study. A diet for 10% weight loss will be provided to each patients individually by a nutritionist. Patients' compliance is monitored by telephone every 15 days. Fasting blood samples are taken from patients at the beginning and at end of the study. The study protocol has been approved by the ethics committee of Iran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Men and women with non-alcoholic fatty liver disease whose ALT is greater than 30 U / l and more than 19 U / L, respectively, and who do not have chronic liver disease, cardiovascular disease, hypertension, or kidney stones are eligible to participate in the study.
Intervention groups
Intervention group: one capsule containing 300 mg of purslane hydroalcoholic extract daily.
Placebo Group: A capsule daily similar in appearance to drug capsules, filled with toasted powder.
Main outcome variables
Serum levels of ALT and AST are the main outcomes of the study. Other variables include fasting blood glucose, insulin, total cholesterol, triglycerides, HDL-C, LDL-C, gamma glutamyl transferase, alkaline phosphatase, glutathione peroxidase, total bilirubin, adiponectin, NF-kB and expression of the NF-κB gene.
General information
Reason for update
1. Submission of information in the old version of IRCT
2. Creating some changes in the sample size after the approval of the Vice Chancellor for Research of Iran University of Medical Sciences
3. Correcting the secondary outcome variables
Acronym
IRCT registration information
IRCT registration number:IRCT201701172709N44
Registration date:2017-04-10, 1396/01/21
Registration timing:prospective
Last update:2020-06-02, 1399/03/13
Update count:2
Registration date
2017-04-10, 1396/01/21
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
Vice Chancellor for Research of Iran university of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hydro-alcoholic extract of Portulaca Oleracea L. (purslane) on Liver enzymes, Glycemic status and lipid profile in non-alcoholic fatty liver disease: a randomized, double-blind clinical trial.
Public title
Effect of purslane extract on non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being volunteer or Wishing to attend
Age 18 years or older
Alanine aminotransferase (ALT) greater than 19 IU/L for women and greater than 30 IU/L for men
Evidence of fatty liver in ultrasonography with a score of 1 or more
BMI ≥ 25 kg/m2
Exclusion criteria:
Other acute or chronic hepatic disorders (hepatitis B or C)
Biliary diseases
Cancer
Hypertension
History of cardiovascular disease
Nephrolithiasis (oxalate stones) or history of oxalate stones
Consumption of omega-3 and vitamin E supplement
Alcohol use
Use of hepatotoxic medications during last month
Changing medication dosage during the study
Pregnancy
Lactation
Compliacne less than 80%
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method has been used for randomization. Blocks of size 4 are generated using www.sealedenvelope.com. In order to conceal in the randomization process, unique codes have been used on the medicine boxes, which are produced by the software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to apply concealment in the randomization process, unique codes will be used on the medicine boxes, and the desired code will also be produced by the software.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-02-22, 1395/12/04
Ethics committee reference number
IR.IUMS.REC 1395.95-04-27-9221324202
Health conditions studied
1
Description of health condition studied
Nonalcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Alanine aminotransferase (ALT)
Timepoint
At the begining and at the end of week 12
Method of measurement
Laboratory kit
2
Description
Aspartate aminotransferase (AST)
Timepoint
At the begining and at the end of week 12
Method of measurement
Laboratory kit
Secondary outcomes
1
Description
Weight
Timepoint
At the begining and at the end of week 12
Method of measurement
Seca scale
2
Description
Body mass index (BMI)
Timepoint
At the begining and at the end of week 12
Method of measurement
Calculation: weight (in kilograms) divided by the square of height (in meters)
3
Description
Waist circumference
Timepoint
At the beginning and at the end of week 12
Method of measurement
Non-stretchable measuring tape
4
Description
Liver steatosis
Timepoint
At the beginning and at the end of week 12
Method of measurement
Sonography
5
Description
Systolic blood pressure (SBP)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Sphygmomanometer
6
Description
Diastolic blood pressure (DBP)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Sphygmomanometer
7
Description
Total cholesterol
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
8
Description
Triglyceride (TG)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
9
Description
High density lipoprotein (HDL)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
10
Description
Low density lipoprotein (LDL)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
11
Description
Albumin (ALB)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
12
Description
Alkaline phosphatase (ALP)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
13
Description
Gamma glutamyl transferase (GGT)
Timepoint
At the begining and at the end of week 12
Method of measurement
Laboratory kit
14
Description
Total bilirubin
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
15
Description
Fasting blood sugar (FBS)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
16
Description
Insulin
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit (ELISA)
17
Description
Homeostatic model assessment of insulin resistance (HOMA-IR)
Dr. Seyyed Abbas Motevallian, deputy head of Research and Technology, Iran University of Medical Sci
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Fax
Email
research-m@iums.ac.ir
Web page address
https://vcr.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
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
00982188607941- 00982188607945
Fax
+98 21 8862 2707
Email
Shidfar.f@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Farzad Shidfar
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Health, Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 7945
Fax
+98 21 8862 2707
Email
Farzadshidfar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Farzad Shidfar
Position
PhD of Nutrition, Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Health, Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 7945
Fax
+98 21 8862 2707
Email
Farzadshidfar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
Information on the main outcomes at the end of the study can be shared.
When the data will become available and for how long
The access period will be 6 months after the publication of the results.
To whom data/document is available
The data from this study will only be available to researchers working at academic and scientific institutions.
Under which criteria data/document could be used
Six months after the publication of the articles of this project, upon request from the corresponding author and his agreement, the study data can be made available to researchers.
From where data/document is obtainable
Applicants can contact the corresponding author via email or the following postal address to receive the required data. Nutrition department, School of health, Iran University of Medical Sciences, Hemmat highsway, 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 data from the present study no later than one week by sending an email to the corresponding author.