The effect of Camelina oil with and without Resistant dextrin supplementation on metabolic, inflammatory and anti-inflammatory markers in patients with Non-alcoholic fatty liver
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Protocol summary
Effect of Camelina oil with and without Resistant dextrin supplementation on metabolic, inflammatory and anti-inflammatory markers in patients with Non-alcoholic fatty liver
Effect of Camelina oil with and without Resistant dextrin supplementation on metabolic, inflammatory, anti-inflammatory, immune markers and mental health in patients with Non-alcoholic fatty liver
Effect of Camelina oil with and without Resistant dextrin supplementation on metabolic, inflammatory and, anti-inflammatory, immune markers and mental health in patients with Non-alcoholic fatty liver
تعیین تاثیر روغن کاملینا با و بدون مکمل یاری دکسترین مقاوم بر شاخصهای متابولیکی، التهابی، ضد التهابی در بیماران مبتلا به کبد چرب غیر الکلی
تعیین تاثیر روغن کاملینا با و بدون مکمل یاری دکسترین مقاوم بر شاخصهای متابولیکی، التهابی، ضد التهابی، ایمنی و سلامت ذهنی در بیماران مبتلا به کبد چرب غیر الکلی
تعیین تاثیر روغن کاملینا با و بدون مکمل یاری دکسترین مقاوم بر شاخصهای متابولیکی، التهابی، ضد التهابی، ایمنی و سلامت ذهنی در بیماران مبتلا به کبد چرب غیر الکلی
General information
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No changes have been made in the protocol of the present study, and only some parameters have been added. According to the comprehensive review on registered trial, all the added parameters along with the recorded parameters were presented as a comprehensive study in this field. Unfortunately, before registering this project in the Iranian Registry of Clinical Trials due to financial constraints, some of the considered parameters were removed. Recently, due to the funding of the project via top researchers grant, researchers have re-added the deleted parameters to the project for a comprehensive study in this field.
No changes have been made in the protocol of the present study, and only some parameters have been added. According to the comprehensive review on registered trial, all the added parameters along with the recorded parameters were presented as a comprehensive study in this field. Unfortunately, before registering this project in the Iranian Registry of Clinical Trials due to financial constraints, some of the considered parameters were removed. Recently, due to the funding of the project via top researchers grant, researchers have re-added the deleted parameters to the project for a comprehensive study in this field.
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تغییراتی در پروتکل مطالعه حاضر انجام نیافته است وفقط برخی پارامترها اضافه شده اند. بر طبق مرور بر متون جامع محققین، کلیه پارامترهای اضافه شده همراه با پارامترهای ثبت شده به صورت یک طرح جامع ارایه گردیده بود. اما قبل از ثبت این طرح در مرکز کارآزمایی های بالینی بواسطه محدودیت مالی، پاره ای از پارامترهای مورد مطالعه حذف گردید. اخیرا بواسطه تامین مالی طرح در قالب گرنت پژوهشی محققین برتر، محققین پارامترهای محذوف را مجددا به طرح اضافه نموده اند تا یک مطالعه جامع در این زمینه صورت پذیرد .
تغییراتی در پروتکل مطالعه حاضر انجام نیافته است وفقط برخی پارامترها اضافه شده اند. بر طبق مرور بر متون جامع محققین، کلیه پارامترهای اضافه شده همراه با پارامترهای ثبت شده به صورت یک طرح جامع ارایه گردیده بود. اما قبل از ثبت این طرح در مرکز کارآزمایی های بالینی بواسطه محدودیت مالی، پاره ای از پارامترهای مورد مطالعه حذف گردید. اخیرا بواسطه تامین مالی طرح در قالب گرنت پژوهشی محققین برتر، محققین پارامترهای محذوف را مجددا به طرح اضافه نموده اند تا یک مطالعه جامع در این زمینه صورت پذیرد .
Primary outcomes
#1
empty
Total antioxidant capacity
Total antioxidant capacity
empty
ظرفیت آنتی اکسیدانی تام
ظرفیت آنتی اکسیدانی تام
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
kit
kit
empty
كيت اختصاصي
كيت اختصاصي
#2
empty
Malondialdehyde
Malondialdehyde
empty
مالون دی آلدئید
مالون دی آلدئید
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
kit
kit
empty
كيت اختصاصي
كيت اختصاصي
#3
empty
8-iso-prostaglandin F2α (8-iso-PGF2α)
8-iso-prostaglandin F2α (8-iso-PGF2α)
empty
8-ایزوپروستاگلاندین F2α
8-ایزوپروستاگلاندین F2α
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
kit
kit
empty
كيت اختصاصي
كيت اختصاصي
#4
empty
superoxide dismutase
superoxide dismutase
empty
سوپر اکسید دیس موتاز
سوپر اکسید دیس موتاز
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
kit
kit
empty
كيت اختصاصي
كيت اختصاصي
#5
empty
leptin
leptin
empty
لپتین
لپتین
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
kit
kit
empty
كيت اختصاصي
كيت اختصاصي
#6
empty
adiponectin
adiponectin
empty
ادیپونکتین
ادیپونکتین
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
kit
kit
empty
كيت اختصاصي
كيت اختصاصي
#7
empty
ghrelin
ghrelin
empty
گرلین
گرلین
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
kit
kit
empty
كيت اختصاصي
كيت اختصاصي
#8
empty
PPAR-α expression
PPAR-α expression
empty
وضعیت اشتها
وضعیت اشتها
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
kit
kit
empty
كيت اختصاصي
كيت اختصاصي
#9
empty
mental health
mental health
empty
سلامت روان
سلامت روان
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
questionnaires
questionnaires
empty
پرسشنامه ها
پرسشنامه ها
#10
empty
lipopolysaccharide
lipopolysaccharide
empty
لیپو پلی ساکارید
لیپو پلی ساکارید
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
kit
kit
empty
كيت اختصاصي
كيت اختصاصي
#11
empty
cd4
cd4
empty
cd4
cd4
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
kit
kit
empty
كيت اختصاصي
كيت اختصاصي
#12
empty
cd8
cd8
empty
cd8
cd8
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
kit
kit
empty
كيت اختصاصي
كيت اختصاصي
#13
empty
ILB1
ILB1
empty
اینترلوکین 1
اینترلوکین 1
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
kit
kit
empty
كيت اختصاصي
كيت اختصاصي
#14
empty
Brain-derived Neurotrophic Factor
Brain-derived Neurotrophic Factor
empty
فاکتور نوتروفیک مشتق شده از مغز
فاکتور نوتروفیک مشتق شده از مغز
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
kit
kit
empty
كيت اختصاصي
كيت اختصاصي
#15
empty
il17
il17
empty
il17
il17
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
kit
kit
empty
كيت اختصاصي
كيت اختصاصي
#16
empty
PPAR-α expression
PPAR-α expression
empty
بیان ژن PPAR-α
بیان ژن PPAR-α
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
pcr
pcr
empty
pcr
pcr
Secondary outcomes
#1
empty
body composition
body composition
empty
ترکیب بدن
ترکیب بدن
empty
At baseline and three months after baseline
At baseline and three months after baseline
empty
ابتدا و سه ماه بعد از شروع مطالعه
ابتدا و سه ماه بعد از شروع مطالعه
empty
BIA devices
BIA devices
empty
دستگاه BIA
دستگاه BIA
Recruitment centers
#1
Name of recruitment center - English: Tabriz International Hospital
Name of recruitment center - Persian: بیمارستان بین المللی تبریز
Full name of responsible person - English: ِDr.Manouchehr khoshbaten
Full name of responsible person - Persian: دکتر منوچهر خوشباطن
Street address - English: Tabriz International Hospital, First Saffronia, Affliction Square
Street address - Persian: بیمارستان بین الملل تبریز، اول زعفرانیه، میدان افلاک نما
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3332 8832
Fax:
Email: mkhoshbaten@yahoo.com
Web page address:
Name of recruitment center - English: Tabriz International Hospital
Name of recruitment center - Persian: بیمارستان بین المللی تبریز
Full name of responsible person - English: ِDr.Manouchehr Khoshbaten
Full name of responsible person - Persian: دکتر منوچهر خوشباطن
Street address - English: Tabriz International Hospital, First of Zaffaraniyeh, Aflaknema Square
Street address - Persian: بیمارستان بین الملل تبریز، ابتدای زعفرانیه، میدان افلاک نما
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3332 8832
Fax:
Email: mkhoshbaten@yahoo.com
Web page address:
Name of recruitment center - English: Tabriz International Hospital Name of recruitment center - Persian: بیمارستان بین المللی تبریز Full name of responsible person - English: ِDr.Manouchehr khoshbatenKhoshbaten Full name of responsible person - Persian: دکتر منوچهر خوشباطن Street address - English: Tabriz International Hospital, First Saffroniaof Zaffaraniyeh, AfflictionAflaknema Square Street address - Persian: بیمارستان بین الملل تبریز، اولابتدای زعفرانیه، میدان افلاک نما City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: +98 41 3332 8832 Fax: Email: mkhoshbaten@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Professor Alireza ostad Rahimi
Full name of responsible person - Persian: دکتر علیرضا استاد رحیمی
Street address - English: Faculty of Nutrition and Nutrition, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
Street address - Persian: تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3335 7581
Fax:
Email: ostadrahimi@tbzmed.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Professor Alireza Ostad Rahimi
Full name of responsible person - Persian: دکتر علیرضا استاد رحیمی
Street address - English: Faculty of Nutrition and Food science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
Street address - Persian: تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 3335 7581
Fax:
Email: ostadrahimi@tbzmed.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Professor Alireza ostadOstad Rahimi Full name of responsible person - Persian: دکتر علیرضا استاد رحیمی Street address - English: Faculty of Nutrition and NutritionFood science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran Street address - Persian: تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: +98 41 3335 7581 Fax: Email: ostadrahimi@tbzmed.ac.ir Web page address:
Protocol summary
Study aim
Effect of Camelina oil with and without Resistant dextrin supplementation on metabolic, inflammatory, anti-inflammatory, immune markers and mental health in patients with Non-alcoholic fatty liver
Design
a triple blind randomized clinical trial with control group and parallel group. sample size is 32
Settings and conduct
This is a triple blind study in Tabriz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 20 to 65 years; BMI≥25; restriction of consumption of edible nuts and fish; propensity to consume camelina and prebiotic oil. Exclusion criteria:Having liver disease other than NAFLD (alcoholic fatty liver, viral hepatitis, cirrhosis and biliary obstruction, liver cancer); liver transplantation; pregnancy; lactation; Kidney; Cardiovascular; Alcohol; Cigarettes & Drugs; High Physical Activity; Acute Disease; Medications Like Glucocorticoids; Last month or special diet; reluctance to take prebiotics and gastrointestinal symptoms; Weight changes in the last 3 months
Intervention groups
Intervention group 1: (Weight loss diet + camelina oil + resistant dextrin + physical activity) Control group: (Weight loss diet + camelina oil + malt dextrin + physical activity)
Main outcome variables
En Alanine amino transferase (ALT); aspartate amino transferase (AST); alkaline phosphatase (ALP); Degree of hepatic steatosis; fasting blood glucose; fasting insulin; insulin resistance; insulin sensitivity; total cholesterol (TC); low triglyceride High density lipoprotein (HDL); tumor necrosis factor-alpha (TNF-α); high-sensitivity c-reactive protein (Hs-CRP); interleukin-10 (IL-10)
General information
Reason for update
No changes have been made in the protocol of the present study, and only some parameters have been added. According to the comprehensive review on registered trial, all the added parameters along with the recorded parameters were presented as a comprehensive study in this field. Unfortunately, before registering this project in the Iranian Registry of Clinical Trials due to financial constraints, some of the considered parameters were removed. Recently, due to the funding of the project via top researchers grant, researchers have re-added the deleted parameters to the project for a comprehensive study in this field.
Acronym
IRCT registration information
IRCT registration number:IRCT20150205020965N4
Registration date:2019-12-13, 1398/09/22
Registration timing:registered_while_recruiting
Last update:2020-09-07, 1399/06/17
Update count:1
Registration date
2019-12-13, 1398/09/22
Registrant information
Name
Parvin Dehghan
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7580
Email address
dehghanp@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-15, 1398/08/24
Expected recruitment end date
2020-05-13, 1399/02/24
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of Camelina oil with and without Resistant dextrin supplementation on metabolic, inflammatory and anti-inflammatory markers in patients with Non-alcoholic fatty liver
Public title
The effect of Camelina oil with and without Resistant dextrin supplementation on Non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 20 to 65 years
BMI≥25
Edible nuts and fish consumption restriction
Tendency to use camelina oil and prebiotic
Having grade 1 and 2 fatty liver disease
Exclusion criteria:
Having other liver disease apart from NAFLD (alcoholic fatty liver, viral hepatitis, cirrhosis and biliary obstruction, liver cancer)
Liver transplantation
Pregnancy, Lactation
Having kidney, Cardiovascular Disease
Alcohol Consumption and smoking
High physical activity
Having acute illness
Use of drugs such as glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDS), hepatotoxic drugs, antibiotics
Taking antioxidant supplements and W3
history of losing weight over the past 6 months or a special diet
Unwillingness to use prebiotics
Gastrointestinal symptoms incidence during the study
Weight changes over the past 3 months
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
At baseline, eligible individuals will be matched for BMI, age, and sex according to the classification of these variables. Individuals will be randomly divided into two groups of 16 intervention (receiving weight loss diet + Camelina oil +Maltodextrin) control (recipient). Weight loss regimen + Camelina oil + Resistant dextrin) divided into 2 and 4 blocks using RAS software and will be given codes 1 and 2.
Blinding (investigator's opinion)
Triple blinded
Blinding description
After randomization, both groups will be fed the camilina oil with identical weight loss regimens with similar recommendations by the expert. Resistant dextrin and maltodextrin will also be encoded in sachets weighing 5 g in similar packages (metallized) by the researcher and coded with codes 1 and 2. Nutritionists will introduce code to patients when giving diet and oil, resistant dextrin and malt dextrin. Until the patient study results are released, the researcher and data analyzer will not be aware of the assigned codes. So the study will be three-blind.
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 Sciences
Street address
Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
In this study, Camelina oil will be replaced with 15% of the daily total fat intake and patients will receive two of 5-mg dextrin-resistant doses every day for three months. Then, 15 days before the beginning of study, FFQ questionnaire will be completed for selected patients based on inclusion and exclusion criteria to determine the dietary pattern of patients. Patients will also be asked not to use omega-3 oils (as mentioned in list) ,prebiotic and probiotic sources during this time. Then, basal energy expenditure of each person will be calculated by Mifflin equation based on their weight, age, sex and total energy expenditure will be calculated according to the person's daily physical activity. For losing weight, 500 kcal reduction of total energy expenditure will be done, and then macronutrients will be distributed to 50% carbohydrate, 30% fat, 20% protein, and the proper diet will be adjusted according to one's dietary pattern. 15% of the dietary fat will be provide by Camelina oil (prepared by cold press, rich in omega-3 fatty acids, then will be analyzed before intervention). Patients will be instructed to measure the recommended amount of oil with the modules given with the oil, and add it to their salad or meal every day (while consuming or cooking), and intake the remain amount from dairy fat, meat and other oils. At the same time, patients will be advised to dissolve one serving of powdered sachets (resistant dextrin) in the lukewarm water each time and consume it by food in the morning and night. The oils and powder supplements will be given monthly to patients, and they will be advised to keep the consuming oil inside the refrigerator, depending on the type of processing (cold press). Each week a phone call will be made to ensure adherence to the diet, supplement intake, and patient status assessment will be done. Patients will be asked to deliver the remaining oil and sachet bottles each month to receive the new oil and sachet bottles for the following month to ensure consumption and following them up. Patients will be advised to avoid fried foods, simple carbohydrates, solid oils and will be advised to use steamed foods as much as possible. Patients will be asked to report any gastrointestinal problems or not possibility of oil intake to available numbers. Metabolic, biochemical, anthropometric parameters, blood pressure and dietary intakes will be assessed before and after intervention.
Category
Treatment - Other
2
Description
In this study, Camelina oil will be replaced with 15% of the daily total fat intake and patients will receive two of 5-mg maltodextrin doses every day for three months. Then, 15 days before the beginning of study, FFQ questionnaire will be completed for selected patients based on inclusion and exclusion criteria to determine the dietary pattern of patients. Patients will also be asked not to use omega-3 oils (as mentioned in list) ,prebiotic and probiotic sources during this time. Then, basal energy expenditure of each person will be calculated by Mifflin equation based on their weight, age, sex and total energy expenditure will be calculated according to the person's daily physical activity. For losing weight, 500 kcal reduction of total energy expenditure will be done, and then macronutrients will be distributed to 50% carbohydrate, 30% fat, 20% protein, and the proper diet will be adjusted according to one's dietary pattern. 15% of the dietary fat will be provide by Camelina oil (prepared by cold press, rich in omega-3 fatty acids, then will be analyzed before intervention). Patients will be instructed to measure the recommended amount of oil with the modules given with the oil, and add it to their salad or meal every day (while consuming or cooking), and intake the remain amount from dairy fat, meat and other oils. At the same time, patients will be advised to dissolve one serving of powdered sachets (maltodextrin) in the lukewarm water each time and consume it by food in the morning and night. The oils and powder supplements will be given monthly to patients, and they will be advised to keep the consuming oil inside the refrigerator, depending on the type of processing (cold press). Each week a phone call will be made to ensure adherence to the diet, supplement intake, and patient status assessment will be done. Patients will be asked to deliver the remaining oil and sachet bottles each month to receive the new oil and sachet bottles for the following month to ensure consumption and following them up. Patients will be advised to avoid fried foods, simple carbohydrates, solid oils and will be advised to use steamed foods as much as possible. Patients will be asked to report any gastrointestinal problems or not possibility of oil intake to available numbers. Metabolic, biochemical, anthropometric parameters, blood pressure and dietary intakes will be assessed before and after intervention.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz International Hospital
Full name of responsible person
ِDr.Manouchehr Khoshbaten
Street address
Tabriz International Hospital, First of Zaffaraniyeh, Aflaknema Square
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3332 8832
Email
mkhoshbaten@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Professor Alireza Ostad Rahimi
Street address
Faculty of Nutrition and Food science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Email
ostadrahimi@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
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41333340634
Email
dehghan.nut@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Nutrition, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41333340634
Email
Dehghan.nut@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Nutrition, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 0634
Email
Dehghan.nut@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Reporting the results
When the data will become available and for how long
after finishing the study and publishing the project articles
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
with permission of Project Researcher and Project Sponsor - Nutrition Research Center
From where data/document is obtainable
Dr Parvin Dehghan, Faculty of Nutrition and Food science, Tabriz University of Medical Sciences Email: Dehghan.nut@gmail.com Phone: +98 914 471 0299
What processes are involved for a request to access data/document
The applicant can send an application to the responsible person by email