Effect of green coffee extract supplementation on metabolic status, serum leptin level and anthropometric measurements in patients with non-alcoholic fatty liver disease
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Protocol summary
Object of study: investigation of the effect of green coffee extract supplementation on metabolic status, serum leptin level and anthropometric measurements in patients with non-alcoholic fatty liver disease (NAFLD).
Study design: Random, double blind, Control with Placebo.
Study population: Patients with NAFLD will be randomly divided into 2 intervention groups:1. green coffee extract recipient group (a capsule 200 mg, after breakfast and one number after lunch) 2. Placebo group (a Placebo capsule containing 200 mg starch after breakfast and one number after lunch). The main criteria for inclusion: Observing hepatic steatosis on ultrasound; age range 20-50 years for women and 20-60 years for men; body mass index (BMI) greater than 25 and less than 35 kilogram per square mete. Main exclusion criteria: alcohol intake; pregnancy; lactation and menopause; liver transplantation; other diagnosis; cancer; Inherited disorders affecting the liver status; hepatotoxic drugs consumption; anticoagulant; vitamins supplements.
Sample size: 48 persons (2 groups of 24 people). (B) Intervention or interventions studied: two group: 1. green coffee extract recipient group 2. Placebo group (c) intervention time: 8 weeks. (D) The primary outcome of the study: The impact of green coffee extract supplementation on metabolic status, serum leptin level and anthropometric measurements. Secondary outcomes of the study: The impact of supplement usage on blood pressure.
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Object of study: investigation of the effect of green coffee extract supplementation on metabolic status, serum leptin level and anthropometric measurements in patients with non-alcoholic fatty liver disease (NAFLD). Study design: Random, double blind, Control with Placebo. Study population: Patients with NAFLD will be randomly divided into 2 intervention groups:1. green coffee extract recipient group (a capsule 200 mg, after breakfast and one number after lunch) 2. Placebo group (a Placebo capsule containing 200 mg starch after breakfast and one number after lunch). The main criteria for inclusion: Observing hepatic steatosis on ultrasound; age range 20-50 years for women and 20-60 years for men; body mass index (BMI) greater than 25 and less than 35 kilogram per square mete. Main exclusion criteria: alcohol intake; pregnancy; lactation and menopause; liver transplantation; other diagnosis; cancer; Inherited disorders affecting the liver status; hepatotoxic drugs consumption; anticoagulant; vitamins supplements. Sample size: 48 persons (2 groups of 24 people). (B) Intervention or interventions studied: two group: 1. green coffee extract recipient group 2. Placebo group (c) intervention time: 8 weeks. (D) The primary outcome of the study: The impact of green coffee extract supplementation on metabolic status, serum leptin level and anthropometric measurements. Secondary outcomes of the study: The impact of supplement usage on blood pressure.
هدف مطالعه: بررسی تأثیر مکمل یاری عصاره قهوه سبز بر وضيعت متابوليك، سطح سرمی لپتین و پارامترهای تن سنجی در افراد مبتلا به كبد چرب غير الكلي. طراحي انجام مطالعه: تصادفی، دو سويه كور، كنترل با دارو نما. جمعيت مورد مطالعه: افراد مبتلا به كبد چرب به صورت تصادفي به 2 گروه، شامل 1. گروه دريافت كننده عصاره قهوه سبز (یک عدد كپسول 200 ميلي گرمي بعد از صبحانه و یک عدد بعد از ناهار) 2. گروه دريافت كننده دارونما (یک عدد كپسول 200 ميلي گرمي حاوی نشاسته بعد از صبحانه و یک عدد بعد از ناهار) تقسیم خواهند شد. معيارهاي اصلي ورود به مطالعه: مشاهده ی استئاتوز در سونوگرافی کبدی، محدوده ی سنی 50-20 سال در زنان و 60-20 سال در مردان؛ نمایه توده ی بدن (BMI) بزرگتر از 25 و كمتر از 35 کیلوگرم بر متر مربع. معيارهاي اصلي خروج از مطالعه: مصرف الکل؛ بارداری، شیردهی و یائسگی؛ انجام پیوند کبد؛ ابتلا به سایر بیماری ها؛ سرطان؛ اختلالات ارثی موثر بر وضعیت کبد؛ مصرف داروهای هپاتوتوکسیک؛ ضد انعقاد خون؛ مكمل هاي ويتاميني. حجم نمونه: 48 نفر (2 گروه 24 نفره). ب- مداخله يا مداخلات مورد مطالعه: دو گروه مداخله: 1. گروه دريافت كننده عصاره قهوه سبز 2. گروه دريافت كننده دارونما ج-زمان مداخله: 8 هفته. د- پيامد اوليه مورد مطالعه: تاثیر مکمل عصاره قهوه سبز بر روی بر وضيعت متابوليك، سطح سرمی لپتین و پارامترهای تن سنجی. پیامد های ثانویه مورد مطالعه: تاثیر مکمل مورد استفاده بر فشارخون.
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هدف مطالعه: بررسی تأثیر مکمل یاری عصاره قهوه سبز بر وضيعت متابوليك، سطح سرمی لپتین و پارامترهای تن سنجی در افراد مبتلا به كبد چرب غير الكلي. طراحي انجام مطالعه: تصادفی، دو سويه كور، كنترل با دارو نما. جمعيت مورد مطالعه: افراد مبتلا به كبد چرب به صورت تصادفي به 2 گروه، شامل 1. گروه دريافت كننده عصاره قهوه سبز (یک عدد كپسول 200 ميلي گرمي بعد از صبحانه و یک عدد بعد از ناهار) 2. گروه دريافت كننده دارونما (یک عدد كپسول 200 ميلي گرمي حاوی نشاسته بعد از صبحانه و یک عدد بعد از ناهار) تقسیم خواهند شد. معيارهاي اصلي ورود به مطالعه: مشاهده ی استئاتوز در سونوگرافی کبدی، محدوده ی سنی 50-20 سال در زنان و 60-20 سال در مردان؛ نمایه توده ی بدن (BMI) بزرگتر از 25 و كمتر از 35 کیلوگرم بر متر مربع. معيارهاي اصلي خروج از مطالعه: مصرف الکل؛ بارداری، شیردهی و یائسگی؛ انجام پیوند کبد؛ ابتلا به سایر بیماری ها؛ سرطان؛ اختلالات ارثی موثر بر وضعیت کبد؛ مصرف داروهای هپاتوتوکسیک؛ ضد انعقاد خون؛ مكمل هاي ويتاميني. حجم نمونه: 48 نفر (2 گروه 24 نفره). ب- مداخله يا مداخلات مورد مطالعه: دو گروه مداخله: 1. گروه دريافت كننده عصاره قهوه سبز 2. گروه دريافت كننده دارونما ج-زمان مداخله: 8 هفته. د- پيامد اوليه مورد مطالعه: تاثیر مکمل عصاره قهوه سبز بر روی بر وضيعت متابوليك، سطح سرمی لپتین و پارامترهای تن سنجی. پیامد های ثانویه مورد مطالعه: تاثیر مکمل مورد استفاده بر فشارخون.
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Investigation of the effect of green coffee extract supplementation on metabolic and oxidative status, serum leptin and adiponectin levels and anthropometric measurements in patients with non-alcoholic fatty liver disease (NAFLD).
Investigation of the effect of green coffee extract supplementation on metabolic and oxidative status, serum leptin and adiponectin levels and anthropometric measurements in patients with non-alcoholic fatty liver disease (NAFLD).
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بررسی تأثیر مکمل یاری عصاره قهوه سبز بر وضيعت متابوليك و اکسیداتیو، سطوح سرمی لپتین و آدیپونکتین و پارامترهای تن سنجی در افراد مبتلا به كبد چرب غير الكلي
بررسی تأثیر مکمل یاری عصاره قهوه سبز بر وضيعت متابوليك و اکسیداتیو، سطوح سرمی لپتین و آدیپونکتین و پارامترهای تن سنجی در افراد مبتلا به كبد چرب غير الكلي
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A randomized, double-blind, placebo-controlled trial
A randomized, double-blind, placebo-controlled trial
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تصادفی، دو سويه كور، كنترل با دارو نما
تصادفی، دو سويه كور، كنترل با دارو نما
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48 patients with NAFLD will be randomly divided into two intervention groups:1. green coffee extract recipient group (one 200 mg capsule after breakfast and one after lunch) 2. placebo group (a placebo capsule containing 200 mg starch after breakfast and one after lunch). Subjects will be recruited from 22 Bahman poly-clinic in Neyshabur, Iran.
48 patients with NAFLD will be randomly divided into two intervention groups:1. green coffee extract recipient group (one 200 mg capsule after breakfast and one after lunch) 2. placebo group (a placebo capsule containing 200 mg starch after breakfast and one after lunch). Subjects will be recruited from 22 Bahman poly-clinic in Neyshabur, Iran.
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تعداد 48 فرد مبتلا به كبد چرب به صورت تصادفي به 2 گروه شامل گروه دريافت كننده عصاره قهوه سبز (یک عدد كپسول 200 ميلي گرمي بعد از صبحانه و یک عدد بعد از ناهار) و گروه دريافت كننده دارونما (یک عدد كپسول 200 ميلي گرمي حاوی نشاسته بعد از صبحانه و یک عدد بعد از ناهار) تقسیم خواهند شد. بیماران مورد مطالعه از پلی کلینیک 22 بهمن شهر نیشابور انتخاب خواهند شد.
تعداد 48 فرد مبتلا به كبد چرب به صورت تصادفي به 2 گروه شامل گروه دريافت كننده عصاره قهوه سبز (یک عدد كپسول 200 ميلي گرمي بعد از صبحانه و یک عدد بعد از ناهار) و گروه دريافت كننده دارونما (یک عدد كپسول 200 ميلي گرمي حاوی نشاسته بعد از صبحانه و یک عدد بعد از ناهار) تقسیم خواهند شد. بیماران مورد مطالعه از پلی کلینیک 22 بهمن شهر نیشابور انتخاب خواهند شد.
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48 patients with NAFLD will be randomly divided into two intervention groups:1. green coffee extract recipient group (one 200 mg capsule after breakfast and one after lunch) 2. placebo group (a placebo capsule containing 200 mg starch after breakfast and one after lunch). The main criteria for inclusion are observing hepatic steatosis on ultrasound, age range 20-50 years for women and 20-60 years for men; body mass index (BMI) greater than 25 and less than 35 kilograms per square meter. The main exclusion criteria are alcohol intake; pregnancy, lactation, and menopause; liver transplantation; cancers; Inherited disorders affecting the liver status; consumption of hepatotoxic drugs, anticoagulants, and vitamin supplements.
48 patients with NAFLD will be randomly divided into two intervention groups:1. green coffee extract recipient group (one 200 mg capsule after breakfast and one after lunch) 2. placebo group (a placebo capsule containing 200 mg starch after breakfast and one after lunch). The main criteria for inclusion are observing hepatic steatosis on ultrasound, age range 20-50 years for women and 20-60 years for men; body mass index (BMI) greater than 25 and less than 35 kilograms per square meter. The main exclusion criteria are alcohol intake; pregnancy, lactation, and menopause; liver transplantation; cancers; Inherited disorders affecting the liver status; consumption of hepatotoxic drugs, anticoagulants, and vitamin supplements.
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تعداد 48 فرد مبتلا به كبد چرب به صورت تصادفي به 2 گروه شامل گروه دريافت كننده عصاره قهوه سبز (یک عدد كپسول 200 ميلي گرمي بعد از صبحانه و یک عدد بعد از ناهار) و گروه دريافت كننده دارونما (یک عدد كپسول 200 ميلي گرمي حاوی نشاسته بعد از صبحانه و یک عدد بعد از ناهار) تقسیم خواهند شد. معيارهاي اصلي ورود به مطالعه شامل مشاهده ی استئاتوز در سونوگرافی کبدی، محدوده ی سنی 50-20 سال در زنان و 60-20 سال در مردان؛ نمایه توده ی بدن (BMI) بزرگتر از 25 و كمتر از 35 کیلوگرم بر متر مربع و معيارهاي اصلي خروج از مطالعه شامل مصرف الکل؛ بارداری، شیردهی و یائسگی؛ انجام پیوند کبد؛ ابتلا به سایر بیماری ها؛ سرطان؛ اختلالات ارثی موثر بر وضعیت کبد؛ مصرف داروهای هپاتوتوکسیک؛ ضد انعقاد خون؛ مكمل هاي ويتاميني هستند.
تعداد 48 فرد مبتلا به كبد چرب به صورت تصادفي به 2 گروه شامل گروه دريافت كننده عصاره قهوه سبز (یک عدد كپسول 200 ميلي گرمي بعد از صبحانه و یک عدد بعد از ناهار) و گروه دريافت كننده دارونما (یک عدد كپسول 200 ميلي گرمي حاوی نشاسته بعد از صبحانه و یک عدد بعد از ناهار) تقسیم خواهند شد. معيارهاي اصلي ورود به مطالعه شامل مشاهده ی استئاتوز در سونوگرافی کبدی، محدوده ی سنی 50-20 سال در زنان و 60-20 سال در مردان؛ نمایه توده ی بدن (BMI) بزرگتر از 25 و كمتر از 35 کیلوگرم بر متر مربع و معيارهاي اصلي خروج از مطالعه شامل مصرف الکل؛ بارداری، شیردهی و یائسگی؛ انجام پیوند کبد؛ ابتلا به سایر بیماری ها؛ سرطان؛ اختلالات ارثی موثر بر وضعیت کبد؛ مصرف داروهای هپاتوتوکسیک؛ ضد انعقاد خون؛ مكمل هاي ويتاميني هستند.
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Group 1: green coffee extract recipient
Group 2: Placebo recipient
Group 1: green coffee extract recipient Group 2: Placebo recipient
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1. گروه دريافت كننده عصاره قهوه سبز 2. گروه دريافت كننده دارونما
1. گروه دريافت كننده عصاره قهوه سبز 2. گروه دريافت كننده دارونما
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Metabolic and oxidative status, serum leptin and adiponectin levels and anthropometric measurements
Metabolic and oxidative status, serum leptin and adiponectin levels and anthropometric measurements
Adding new factors of supplementary research in this study
Adding new factors of supplementary research in this study
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اضافه کردن فاکتورهای جدید برای طرح مکمل مطالعه حاضر
اضافه کردن فاکتورهای جدید برای طرح مکمل مطالعه حاضر
Nonalcoholic fatty liver (observation of liver steatosis on Sonographic image)
The age range of 20-50 years in women and 20-60 years in men
Body mass index greater than 25 and less than 35 kilograms per Square meters
Nonalcoholic fatty liver (observation of liver steatosis on Sonographic image) The age range of 20-50 years in women and 20-60 years in men Body mass index greater than 25 and less than 35 kilograms per Square meters
ابتلا به کبد چرب غیر الکلی (مشاهده ی استئاتوز در سونوگرافی کبدی)
محدوده ی سنی 50-20 سال در زنان و 60-20 سال در مردان
نمایه توده ی بدن بزرگتر از 25 و كمتر از 35 کیلوگرم بر متر مربع
ابتلا به کبد چرب غیر الکلی (مشاهده ی استئاتوز در سونوگرافی کبدی) محدوده ی سنی 50-20 سال در زنان و 60-20 سال در مردان نمایه توده ی بدن بزرگتر از 25 و كمتر از 35 کیلوگرم بر متر مربع
Alcohol intake
Gestation, Lactation, and Menopause
Following a weight reducing diet
Professional athletes
History or current diagnosis of anemia, cardiovascular disease; gastrointestinal disease, diabetes, pulmonary disease, renal disease, acute or chronic liver disorders (Hepatitis A, B, ...), biliary impairments, biliary or kidney stones; autoimmune disease, cancers, Inherited disorders affecting the liver, and other diseases
Use of medications such as hepatotoxic drugs, anticoagulant drugs, hormonal drugs (e.g., oral contraceptives and/or estrogen), and consuming dietary supplements such as vitamin A, E, C, and omega-3 three months prior to the study and/or during the study period.
Alcohol intake Gestation, Lactation, and Menopause Following a weight reducing diet Professional athletes History or current diagnosis of anemia, cardiovascular disease; gastrointestinal disease, diabetes, pulmonary disease, renal disease, acute or chronic liver disorders (Hepatitis A, B, ...), biliary impairments, biliary or kidney stones; autoimmune disease, cancers, Inherited disorders affecting the liver, and other diseases Use of medications such as hepatotoxic drugs, anticoagulant drugs, hormonal drugs (e.g., oral contraceptives and/or estrogen), and consuming dietary supplements such as vitamin A, E, C, and omega-3 three months prior to the study and/or during the study period.
مصرف الکل
بارداری، شیردهی و یائسگی
پيروي از رژيم كاهش وزن
ورزشکار بودن
ابتلا به كم خوني؛ سابقه یا ابتلا به بیماری های قلبی-عروقی، گوارشي، ديابت، بیماری های ریوی، کلیوی، اختلالات مزمن یا حاد کبدی (هپاتیت B، A ...)، بیماری صفراوی، انجام پیوند کبد، وجود سنگ كيسه صفرا يا سنگ كليه، بیماری خودایمنی، سرطان، اختلالات ارثی موثر بر وضعیت کبد و سایر بیماری ها
مصرف داروهای هپاتوتوکسیک، ضد انعقاد خون، قرص های ضد بارداری و استروژن و مصرف مكمل هاي تغذیه ای از جمله ويتامين هاي E ،A ،C و امگا 3 سه ماه قبل از شروع و یا در طول مطالعه
مصرف الکل بارداری، شیردهی و یائسگی پيروي از رژيم كاهش وزن ورزشکار بودن ابتلا به كم خوني؛ سابقه یا ابتلا به بیماری های قلبی-عروقی، گوارشي، ديابت، بیماری های ریوی، کلیوی، اختلالات مزمن یا حاد کبدی (هپاتیت B، A ...)، بیماری صفراوی، انجام پیوند کبد، وجود سنگ كيسه صفرا يا سنگ كليه، بیماری خودایمنی، سرطان، اختلالات ارثی موثر بر وضعیت کبد و سایر بیماری ها مصرف داروهای هپاتوتوکسیک، ضد انعقاد خون، قرص های ضد بارداری و استروژن و مصرف مكمل هاي تغذیه ای از جمله ويتامين هاي E ،A ،C و امگا 3 سه ماه قبل از شروع و یا در طول مطالعه
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Randomization was carried out using a block randomization procedure of size 4 and was stratified by age, sex, and BMI. Random allocation software (RAS)
was used for generating a random sequence.
Randomization was carried out using a block randomization procedure of size 4 and was stratified by age, sex, and BMI. Random allocation software (RAS) was used for generating a random sequence.
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برای تصادفی سازی از روش بلوک های تصادفی سایز 4 استفاده شد که بر اساس سن، جنس و نمایه توده بدنی تطبیق داده شدند. برای ایجاد بلوک های تصادفی از نرم افزار تصادفی سازی RAS استفاده شد.
برای تصادفی سازی از روش بلوک های تصادفی سایز 4 استفاده شد که بر اساس سن، جنس و نمایه توده بدنی تطبیق داده شدند. برای ایجاد بلوک های تصادفی از نرم افزار تصادفی سازی RAS استفاده شد.
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An independent person not involved in the study process prepared both green coffee extract and placebo bottles and labeled them as A or B. All of the supplement packs were identically provided. The patients and researchers were all blinded to the treatment assignment until the statistical analyses were completed.
An independent person not involved in the study process prepared both green coffee extract and placebo bottles and labeled them as A or B. All of the supplement packs were identically provided. The patients and researchers were all blinded to the treatment assignment until the statistical analyses were completed.
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یک نفر خارج از مطالعه کپسول های عصاره قهوه سبز و دارونما را که از نظر رنگ و شکل و جنس و اندازه مشابه بودند در بسته بندی های با کدهای A و B آماده کرد. بیماران و محققین تا زمان آنالیز نهایی داده ها از محتوای بسته بندی ها اطلاعی نداشتند.
یک نفر خارج از مطالعه کپسول های عصاره قهوه سبز و دارونما را که از نظر رنگ و شکل و جنس و اندازه مشابه بودند در بسته بندی های با کدهای A و B آماده کرد. بیماران و محققین تا زمان آنالیز نهایی داده ها از محتوای بسته بندی ها اطلاعی نداشتند.
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Ethics committees
#1
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2019-11-24, 1398/09/03
2019-11-24 00:00:00
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IR.TBZMED.REC.1398.918
IR.TBZMED.REC.1398.918
Primary outcomes
#1
Beginning and eighth week of the study
Baseline and after the intervention
BeginningBaseline and eighth week ofafter the studyintervention
ابتدا و هفته هشتم مطالعه
ابتدا و انتهای مطالعه
ابتدا و هفته هشتمانتهای مطالعه
#2
Beginning and eighth week of the study
Baseline and after the intervention
BeginningBaseline and eighth week ofafter the studyintervention
ابتدا و هفته هشتم مطالعه
ابتدا و انتهای مطالعه
ابتدا و هفته هشتمانتهای مطالعه
#3
Beginning and eighth week of the study
Baseline and after the intervention
BeginningBaseline and eighth week ofafter the studyintervention
ابتدا و هفته هشتم مطالعه
ابتدا و انتهای مطالعه
ابتدا و هفته هشتمانتهای مطالعه
#4
Beginning and eighth week of the study
Baseline and after the intervention
BeginningBaseline and eighth week ofafter the studyintervention
ابتدا و هفته هشتم مطالعه
ابتدا و انتهای مطالعه
ابتدا و هفته هشتمانتهای مطالعه
#5
Beginning and eighth week of the study
Baseline and after the intervention
BeginningBaseline and eighth week ofafter the studyintervention
ابتدا و هفته هشتم مطالعه
ابتدا و انتهای مطالعه
ابتدا و هفته هشتمانتهای مطالعه
#6
Beginning and eighth week of the study
Baseline and after the intervention
BeginningBaseline and eighth week ofafter the studyintervention
ابتدا و هفته هشتم مطالعه
ابتدا و انتهای مطالعه
ابتدا و هفته هشتمانتهای مطالعه
#7
Beginning and eighth week of the study
Baseline and after the intervention
BeginningBaseline and eighth week ofafter the studyintervention
ابتدا و هفته هشتم مطالعه
ابتدا و انتهای مطالعه
ابتدا و هفته هشتمانتهای مطالعه
#8
empty
Serum adiponectin level
Serum adiponectin level
empty
سطح سرمی آدیپونکتین
سطح سرمی آدیپونکتین
empty
Baseline and after the intervention
Baseline and after the intervention
empty
ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
empty
ELISA
ELISA
empty
الایزا
الایزا
#9
empty
Oxidative status (TAC, MDA)
Oxidative status (TAC, MDA)
empty
وضعيت اكسيداتيو (TAC ،MDA )
وضعيت اكسيداتيو (TAC ،MDA )
empty
Baseline and after the intervention
Baseline and after the intervention
empty
ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
empty
Biochemical
Biochemical
empty
بیوشیمیایی
بیوشیمیایی
Recruitment centers
#1
Name of recruitment center - English: 22 Bahman hospital
Name of recruitment center - Persian: کلینیک بیمارستان 22 بهمن نیشابور
Full name of responsible person - English: Samaneh Hosseinabadi
Full name of responsible person - Persian: سمانه حسین آبادی
Street address - English: Imam Khomeini Ave, Iran Sq, Neyshabor
Street address - Persian: خراسان رضوی، نیشابور، خیابان امام خمینی، فلکه ایران
City - English: Neyshabor
City - Persian: نیشابور
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: 22 Bahman hospital
Name of recruitment center - Persian: کلینیک بیمارستان 22 بهمن نیشابور
Full name of responsible person - English: Samaneh Hosseinabadi
Full name of responsible person - Persian: سمانه حسین آبادی
Street address - English: Imam Khomeini Ave, Iran Sq, Neyshabor
Street address - Persian: خراسان رضوی، نیشابور، خیابان امام خمینی، فلکه ایران
City - English: Neyshabor
City - Persian: نیشابور
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 93186-14139
Phone: +98 51 4333 3611
Fax: +98 51 4333 8153
Email: 22bahman@nums.ac.ir
Web page address:
Name of recruitment center - English: 22 Bahman hospital Name of recruitment center - Persian: کلینیک بیمارستان 22 بهمن نیشابور Full name of responsible person - English: Samaneh Hosseinabadi Full name of responsible person - Persian: سمانه حسین آبادی Street address - English: Imam Khomeini Ave, Iran Sq, Neyshabor Street address - Persian: خراسان رضوی، نیشابور، خیابان امام خمینی، فلکه ایران City - English: Neyshabor City - Persian: نیشابور Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 93186-14139 Phone: +98 51 4333 3611 Fax: +98 51 4333 8153 Email: 22bahman@nums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr Alirza Ostadrahimi
Full name of responsible person - Persian: دکتر علیرضا استادرحیمی
Street address - English: Tabriz University of Medical Sciences, Golgasht Ave, Tabriz
Street address - Persian: تبریز، خيابان گلگشت، دانشگاه علوم پزشكي تبريز
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr Alirza Ostadrahimi
Full name of responsible person - Persian: دکتر علیرضا استادرحیمی
Street address - English: Tabriz University of Medical Sciences, Golgasht Ave, Tabriz
Street address - Persian: تبریز، خيابان گلگشت، دانشگاه علوم پزشكي تبريز
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3335 2292
Fax:
Email: nut-rc@tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Dr Alirza Ostadrahimi Full name of responsible person - Persian: دکتر علیرضا استادرحیمی Street address - English: Tabriz University of Medical Sciences, Golgasht Ave, Tabriz Street address - Persian: تبریز، خيابان گلگشت، دانشگاه علوم پزشكي تبريز City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: +98 41 3335 2292 Fax: Email: nut-rc@tbzmed.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
Full name of responsible person - English: Samaneh Hosseinabadi
Full name of responsible person - Persian: سمانه حسین آبادی
Position - English: MSc Student of Nutrition Sciences
Position - Persian: دانشجوی کارشناسی ارشد علوم تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz
Street address - Persian: تبریز، خیابان گلگشت، خیابان عطار نیشابوری، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3335 7581
Mobile: +98 939 894 0291
Fax: +98 41 3334 0634
Email: saman7347@gmail.cm
Web page address:
contact.organization_id:
Name of organization / entity - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
Full name of responsible person - English: Samaneh Hosseinabadi
Full name of responsible person - Persian: سمانه حسین آبادی
Position - English: MSc Student of Nutrition Sciences
Position - Persian: دانشجوی کارشناسی ارشد علوم تغذیه
Latest degree: bachelor
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz
Street address - Persian: تبریز، خیابان گلگشت، خیابان عطار نیشابوری، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3335 7581
Mobile: +98 939 894 0291
Fax: +98 41 3334 0634
Email: saman7347@gmail.cm
Web page address:
contact.organization_id: Name of organization / entity - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی Full name of responsible person - English: Samaneh Hosseinabadi Full name of responsible person - Persian: سمانه حسین آبادی Position - English: MSc Student of Nutrition Sciences Position - Persian: دانشجوی کارشناسی ارشد علوم تغذیه Latest degree: bachelor Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz Street address - Persian: تبریز، خیابان گلگشت، خیابان عطار نیشابوری، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: +98 41 3335 7581 Mobile: +98 939 894 0291 Fax: +98 41 3334 0634 Email: saman7347@gmail.cm Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
Full name of responsible person - English: Samaneh Hosseinabadi
Full name of responsible person - Persian: سمانه حسین آبادی
Position - English: MSc Student of Nutrition Sciences
Position - Persian: دانشجوی کارشناسی ارشد علوم تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz
Street address - Persian: تبریز، خیابان گلگشت، خیابان عطار نیشابوری، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3335 7581
Mobile: +98 939 894 0291
Fax: +98 41 3334 0634
Email: saman7347@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
Full name of responsible person - English: Maryam Rafraf
Full name of responsible person - Persian: مریم رف رف
Position - English: Ph.D in Nutrition Sciences
Position - Persian: دکترای تخصصی تغذیه
Latest degree: phd
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz
Street address - Persian: تبریز، خیابان گلگشت، خیابان عطار نیشابوری، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3335 7584
Mobile: +98 41 3335 7584
Fax: +98 41 3334 0634
Email: rafrafm@tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی Full name of responsible person - English: Samaneh HosseinabadiMaryam Rafraf Full name of responsible person - Persian: سمانه حسین آبادیمریم رف رف Position - English: MSc Student ofPh.D in Nutrition Sciences Position - Persian: دانشجوی کارشناسی ارشد علومدکترای تخصصی تغذیه Latest degree: phd Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz Street address - Persian: تبریز، خیابان گلگشت، خیابان عطار نیشابوری، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: +98 41 3335 75817584 Mobile: +98 939 894 029141 3335 7584 Fax: +98 41 3334 0634 Email: saman7347rafrafm@gmail.comtbzmed.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Nutrition and Food Sciencs Faculty, Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
Full name of responsible person - English: Samaneh Hosseinabadi
Full name of responsible person - Persian: سمانه حسین آبادی
Position - English: MSc Student of Nutrition Sciences
Position - Persian: دانشجوی کارشناسی ارشد علوم تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz
Street address - Persian: تبریز، خیابان گلگشت، خیابان عطار نیشابوری، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3335 7581
Mobile: +98 939 894 0291
Fax: +98 41 3334 0634
Email: saman7347@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Nutrition and Food Sciencs Faculty, Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
Full name of responsible person - English: Samaneh Hosseinabadi
Full name of responsible person - Persian: سمانه حسین آبادی
Position - English: MSc Student of Nutrition Sciences
Position - Persian: دانشجوی کارشناسی ارشد علوم تغذیه
Latest degree: bachelor
Area of specialty/work: 0
Area of specialty/work title - English: nutrition
Area of specialty/work title - Persian: علوم تغذیه
Street address - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz
Street address - Persian: تبریز، خیابان گلگشت، خیابان عطار نیشابوری، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3335 7581
Mobile: +98 939 894 0291
Fax: +98 41 3334 0634
Email: saman7347@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Nutrition and Food Sciencs Faculty, Tabriz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی Full name of responsible person - English: Samaneh Hosseinabadi Full name of responsible person - Persian: سمانه حسین آبادی Position - English: MSc Student of Nutrition Sciences Position - Persian: دانشجوی کارشناسی ارشد علوم تغذیه Latest degree: bachelor Area of specialty/work: 0 Area of specialty/work title - English: nutrition Area of specialty/work title - Persian: علوم تغذیه Street address - English: Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz Street address - Persian: تبریز، خیابان گلگشت، خیابان عطار نیشابوری، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: +98 41 3335 7581 Mobile: +98 939 894 0291 Fax: +98 41 3334 0634 Email: saman7347@gmail.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
na
na
undecided
undecided
na
na
na
na
na
na
empty
needs administrator agreement
needs administrator agreement
empty
کسب اجازه از مجری طرح
کسب اجازه از مجری طرح
Protocol summary
Study aim
Investigation of the effect of green coffee extract supplementation on metabolic and oxidative status, serum leptin and adiponectin levels and anthropometric measurements in patients with non-alcoholic fatty liver disease (NAFLD).
Design
A randomized, double-blind, placebo-controlled trial
Settings and conduct
48 patients with NAFLD will be randomly divided into two intervention groups:1. green coffee extract recipient group (one 200 mg capsule after breakfast and one after lunch) 2. placebo group (a placebo capsule containing 200 mg starch after breakfast and one after lunch). Subjects will be recruited from 22 Bahman poly-clinic in Neyshabur, Iran.
Participants/Inclusion and exclusion criteria
48 patients with NAFLD will be randomly divided into two intervention groups:1. green coffee extract recipient group (one 200 mg capsule after breakfast and one after lunch) 2. placebo group (a placebo capsule containing 200 mg starch after breakfast and one after lunch). The main criteria for inclusion are observing hepatic steatosis on ultrasound, age range 20-50 years for women and 20-60 years for men; body mass index (BMI) greater than 25 and less than 35 kilograms per square meter. The main exclusion criteria are alcohol intake; pregnancy, lactation, and menopause; liver transplantation; cancers; Inherited disorders affecting the liver status; consumption of hepatotoxic drugs, anticoagulants, and vitamin supplements.
Intervention groups
Group 1: green coffee extract recipient
Group 2: Placebo recipient
Main outcome variables
Metabolic and oxidative status, serum leptin and adiponectin levels and anthropometric measurements
General information
Reason for update
Adding new factors of supplementary research in this study
Acronym
IRCT registration information
IRCT registration number:IRCT201602113664N17
Registration date:2016-04-08, 1395/01/20
Registration timing:registered_while_recruiting
Last update:2019-12-12, 1398/09/21
Update count:1
Registration date
2016-04-08, 1395/01/20
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Student research center of Tabriz University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-09-05, 1395/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of green coffee extract supplementation on metabolic status, serum leptin level and anthropometric measurements in patients with non-alcoholic fatty liver disease
Public title
The effect of green coffee extract in the treatment of non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Nonalcoholic fatty liver (observation of liver steatosis on Sonographic image)
The age range of 20-50 years in women and 20-60 years in men
Body mass index greater than 25 and less than 35 kilograms per Square meters
Exclusion criteria:
Alcohol intake
Gestation, Lactation, and Menopause
Following a weight reducing diet
Professional athletes
History or current diagnosis of anemia, cardiovascular disease; gastrointestinal disease, diabetes, pulmonary disease, renal disease, acute or chronic liver disorders (Hepatitis A, B, ...), biliary impairments, biliary or kidney stones; autoimmune disease, cancers, Inherited disorders affecting the liver, and other diseases
Use of medications such as hepatotoxic drugs, anticoagulant drugs, hormonal drugs (e.g., oral contraceptives and/or estrogen), and consuming dietary supplements such as vitamin A, E, C, and omega-3 three months prior to the study and/or during the study period.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was carried out using a block randomization procedure of size 4 and was stratified by age, sex, and BMI. Random allocation software (RAS)
was used for generating a random sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
An independent person not involved in the study process prepared both green coffee extract and placebo bottles and labeled them as A or B. All of the supplement packs were identically provided. The patients and researchers were all blinded to the treatment assignment until the statistical analyses were completed.
Placebo
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 Science
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2016-02-10, 1394/11/21
Ethics committee reference number
TBZMED.REC.1394.1031
2
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Science
Street address
Golgasht Ave, Tabriz University of Medical Sciences,
Intervention Group: Intake of Green coffee extract 200 mg capsules two times a day, Prepared by Bonian Salamat Kasra company, for 8 weeks.
Category
Treatment - Drugs
2
Description
Placebo groups: Intake a Placebo capsule containing 200 mg of starch, which is similar to green coffee extract supplement in terms of dosage, color and size, twice a day for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman hospital
Full name of responsible person
Samaneh Hosseinabadi
Street address
Imam Khomeini Ave, Iran Sq, Neyshabor
City
Neyshabor
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 51 4333 3611
Fax
+98 51 4333 8153
Email
22bahman@nums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Alirza Ostadrahimi
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
nut-rc@tbzmed.ac.ir
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 and Food Sciences Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Samaneh Hosseinabadi
Position
MSc Student of Nutrition Sciences
Latest degree
Bachelor
Other areas of specialty/work
Street address
Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
+98 41 3334 0634
Email
saman7347@gmail.cm
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Maryam Rafraf
Position
Ph.D in Nutrition Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7584
Fax
+98 41 3334 0634
Email
rafrafm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nutrition and Food Sciencs Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Samaneh Hosseinabadi
Position
MSc Student of Nutrition Sciences
Latest degree
Bachelor
Other areas of specialty/work
nutrition
Street address
Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
+98 41 3334 0634
Email
saman7347@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available