Effects of resveratrol on lipid and glycemic profile indices, expression of PPARα, some factors associated with cell cycle arrest and sCD163 to sTWEAK ration in T2DM patients.
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Protocol summary
The present study will be conducted on type 2 diabetes patients who have been diagnosed with diabetes based on WHO criteria and approved by the endocrinologist. Randomization will be conducted based on stratified blocked randomization method using two parameters of gender and age. Eventually, 72 patients will be introduced into the group receiving resveratrol (at a dose of 1000 mg) and the placebo (methyl cellulose) recipients by stratification using random number table.
A double blind controlled randomized parallel clinical Trial, will be performed on patients with type 2 diabetes. 72 patients will be randomly assigned to groups receiving resveratrol and the placebo group.
The present studyA double blind controlled randomized parallel clinical Trial, will be conductedperformed on patients with type 2 diabetes patients who have been diagnosed with diabetes based on WHO criteria and approved by the endocrinologist. Randomization will be conducted based on stratified blocked randomization method using two parameters of gender and age. Eventually, 72 patients will be introduced into the grouprandomly assigned to groups receiving resveratrol (at a dose of 1000 mg) and the placebo (methyl cellulose) recipients by stratification using random number tablegroup.
مطالعه حاضر روي بیماران مبتلا به دیابت نوع دو که ابتلا به دیابت براساس معیارهای WHO و توسط متخصص غدد تائید شده باشد انجام خواهد شد. و تصادفی سازی براساس روش stratified blocked randomization و با استفاده از دو پارامتر جنس و سن انجام خواهد شد. در نهایت 72 بیمار به روش تصادفی و با استفاده از جدول اعداد تصادفی به گروه های دریافت کننده رزوراترول (با دوز 1000 میلیگرم) و گروه دریافت کننده دارونما (متیل سلولز) وارد خواهند شد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور و تصادفی شده روي بیماران مبتلا به دیابت نوع دو انجام خواهد شد. 72 بیمار با استفاده از جدول اعداد تصادفی به گروه های دریافت کننده رزوراترول و گروه دریافت کننده دارونما وارد خواهند شد.
مطالعه حاضرکارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور و تصادفی شده روي بیماران مبتلا به دیابت نوع دو که ابتلا به دیابت براساس معیارهای WHO و توسط متخصص غدد تائید شده باشد انجام خواهد شد. و تصادفی سازی براساس روش stratified blocked randomization و با استفاده از دو پارامتر جنس و سن انجام خواهد شد. در نهایت 72 بیمار به روش تصادفی و با استفاده از جدول اعداد تصادفی به گروه های دریافت کننده رزوراترول (با دوز 1000 میلیگرم) و گروه دریافت کننده دارونما (متیل سلولز) وارد خواهند شد.
The present study will be conducted in a double blind randomized controlled trial. Participants and researchers will not be aware of the supplemental and placebo content.The duration of the intervention will be 8 weeks. After giving a complete explanation about how the study is done, blood sampling and obtaining informed consent form, a demographic questionnaire will be completed at the beginning of the study. Two 3-day food record form is delivered to the patients and is required to write their food items, of the first and the last week of the study. (2 weekdays and 1 weekend). The level of physical activity will be measured using the MET questionnaire once at the beginning of the intervention and once at the end of the intervention. Anthropometric measurements including height, weight, waist circumference, hip circumference and body composition will be estimated at the beginning and end of the study. After 12 hours fasting, 10 ml of venous blood sample will be collected at the beginning and end of the intervention. Biochemical analyses will be including lipid profile (total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol) serum fasting blood glucose, fasting insulin and HbA1c, which will be measured by the standard methods. The gene expression of p16, p53, p21 and PPARα will be investigated at mRNA level using the Real Time PCR method. Commercially available ELISA kits will be used to measure serum sCD163 and sTWEAK.
The present study will be conducted in a double blind randomized controlled trial. Participants and researchers will not be aware of the supplemental and placebo content. After giving a complete explanation about how the study is done, blood sampling and obtaining informed consent form, a demographic questionnaire will be completed at the beginning of the study. The diet, the level of physical activity, and body composition will be examined using standard methods at the beginning and end of the study. The mRNA expression levels for PPARα, p53, p21 and p16 genes will be assessed using real-time polymerase chain reaction (PCR) and serum CD163 and TWEAK levels will be measured using commercially available ELISA kits at baseline and the end of the study.
The present study will be conducted in a double blind randomized controlled trial. Participants and researchers will not be aware of the supplemental and placebo content.The duration of the intervention will be 8 weekscontent. After giving a complete explanation about how the study is done, blood sampling and obtaining informed consent form, a demographic questionnaire will be completed at the beginning of the study. Two 3-day food record form is delivered toThe diet, the patients and is required to write their food items, of the first and the last week of the study. (2 weekdays and 1 weekend). The level of physical activity will be measured using the MET questionnaire once at the beginning of the intervention and once at the end of the intervention. Anthropometric measurements including height, weight, waist circumference, hip circumference and body composition will be estimatedexamined using standard methods at the beginning and end of the study. After 12 hours fasting, 10 ml of venous blood sample will be collected at the beginning and end of the intervention. Biochemical analyses will be including lipid profile (total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol) serum fasting blood glucose, fasting insulin and HbA1c, which will be measured by the standard methods. The genemRNA expression of p16levels for PPARα, p53, p21 and PPARαp16 genes will be investigated at mRNA levelassessed using the Real Time real-time polymerase chain reaction (PCR method. Commercially) and serum CD163 and TWEAK levels will be measured using commercially available ELISA kits will be used to measure serum sCD163at baseline and sTWEAKthe end of the study.
مطالعه حاضر در قالب مطالعه مداخله اي تصادفي دوسوکور انجام خواهد شد. شرکت کنندگان و محقق از محتوای مکمل و دارونما اطلاعی ندارند. مدت زمان انجام مداخله 8 هفته خواهد بود. پس از ارائه توضیحات کامل در مورد نحوه انجام مطالعه، خونگیری و اخذ فرم رضایت آگاهانه، پرسشنامه مربوط به اطلاعات دموگرافيک در ابتداي مطالعه تکميل خواهد شد. فرم ثبت غذايي 3 روزه به بيماران تحويل داده شده و از آنها درخواست می شود تا در هفته آغاز و هفته پايان مطالعه اقلام خوراکي مصرفي خود را در 3 روز (2 روز غيرتعطيل و 1 روز تعطيل) يادداشت نمايند. سطح فعاليت فيزيکي با استفاده از پرسشنامه MET یکبار در آغاز مداخله و یکبار در پایان مداخله تخمين زده خواهد شد. اندازه گیری های تن سنجی شامل قد، وزن، دور کمر، دور باسن و ترکیب بدن در ابتدا و انتهای مطالعه برآورد خواهد شد. خونگیری از بیماران پس از 12 ساعت ناشتایی، در دو نوبت ابتدا و انتهای مطالعه به میزان cc 10 انجام خواهد شد. پروفایل لیپیدی بیماران (تري گليسيريد، كلسترول تام، کلسترول LDL، كلسترول HDL)، قند خون ناشتا، هموگلوبین گلیکوزیله (HbA1c) و انسولين ناشتا، به روش استاندارد، بیان ژنهای p16، p53 ،p21 و PPARα در سطح mRNA به روش Real Time PCR ، سطوح سرمی sCD163 و sTWEAK با روش ELISA یکبار در آغاز مداخله و یکبار در زمان اتمام مداخله اندازه گیری خواهد شد.
مطالعه حاضر در قالب مطالعه مداخله اي تصادفي دوسوکور انجام خواهد شد. شرکت کنندگان و محقق از محتوای مکمل و دارونما اطلاعی ندارند. پس از اخذ فرم رضایت آگاهانه، پرسشنامه مربوط به اطلاعات دموگرافيک در ابتداي مطالعه تکميل خواهد شد. دریافت رژیمی، سطح فعالیت فیزیکی و ترکیب بدن با استفاده از روش های استاندارد در ابتدا و انتهای مطالعه بررسی خواهد شد. بیان ژن های PPARα, p53, p21 و p16 به روش PCR و سطوح سرمی CD163 و TWEAK به روش الایزا در ابتدا و انتهای مطالعه اندازه گیری خواهد شد.
مطالعه حاضر در قالب مطالعه مداخله اي تصادفي دوسوکور انجام خواهد شد. شرکت کنندگان و محقق از محتوای مکمل و دارونما اطلاعی ندارند. مدت زمان انجام مداخله 8 هفته خواهد بود. پس از ارائه توضیحات کامل در مورد نحوه انجام مطالعه، خونگیری و اخذ فرم رضایت آگاهانه، پرسشنامه مربوط به اطلاعات دموگرافيک در ابتداي مطالعه تکميل خواهد شد. فرم ثبت غذايي 3 روزه به بيماران تحويل داده شدهدریافت رژیمی، سطح فعالیت فیزیکی و از آنها درخواست می شود تا در هفته آغاز و هفته پايان مطالعه اقلام خوراکي مصرفي خود را در 3 روز (2 روز غيرتعطيل و 1 روز تعطيل) يادداشت نمايند. سطح فعاليت فيزيکيترکیب بدن با استفاده از پرسشنامه MET یکبار در آغاز مداخله و یکبار در پایان مداخله تخمين زده خواهد شد. اندازه گیریروش های تن سنجی شامل قد، وزن، دور کمر، دور باسن و ترکیب بدناستاندارد در ابتدا و انتهای مطالعه برآوردبررسی خواهد شد. خونگیری از بیماران پس از 12 ساعت ناشتایی،بیان ژن های PPARα, p53, p21 و p16 به روش PCR و سطوح سرمی CD163 و TWEAK به روش الایزا در دو نوبت ابتدا و انتهای مطالعه به میزان cc 10 انجام خواهد شد. پروفایل لیپیدی بیماران (تري گليسيريد، كلسترول تام، کلسترول LDL، كلسترول HDL)، قند خون ناشتا، هموگلوبین گلیکوزیله (HbA1c) و انسولين ناشتا، به روش استاندارد، بیان ژنهای p16، p53 ،p21 و PPARα در سطح mRNA به روش Real Time PCR ، سطوح سرمی sCD163 و sTWEAK با روش ELISA یکبار در آغاز مداخله و یکبار در زمان اتمام مداخله اندازه گیری خواهد شد.
Male and female with type 2 diabetes mellitus, aged 30-60 years with a body mass index of 24-30 kg/m2 will be included in the study. People who have other illnesses, have antioxidant supplements or alcoholic beverages, have uncontrolled blood glucose or take insulin, and pregnant or lactating women will not be included in the study.
Male and female with type 2 diabetes mellitus, aged 30-60 years with a body mass index of 24-30 kg/m2 will be included in the study. Individuals with special conditions (pregnant, lactating, addicted, with other diseases and insulin use) will not be included in the study.
Male and female with type 2 diabetes mellitus, aged 30-60 years with a body mass index of 24-30 kg/m2 will be included in the study. People who haveIndividuals with special conditions (pregnant, lactating, addicted, with other illnesses, have antioxidant supplements or alcoholic beverages, have uncontrolled blood glucose or take insulin,diseases and pregnant or lactating womeninsulin use) will not be included in the study.
زنان و مردان مبتلا به دیابت نوع دو در محدوده سنی 30-60 سال و نمایه توده بدنی 30-24 کیلوگرم بر متر مربع وارد مطالعه خواهند شد. افرادی که مبتلا به بیماری های دیگری باشند، مکمل حاوی انتی اکسیدان و یا مشروبات الکلی مصرف کنند، قند خون کنترل نشده داشته باشند یا انسولین مصرف کنند و یا باردار یا شیرده باشند وارد مطالعه نخواهند شد.
زنان و مردان مبتلا به دیابت نوع دو در محدوده سنی 30-60 سال و نمایه توده بدنی 30-24 کیلوگرم بر متر مربع وارد مطالعه خواهند شد. افراد با شرایط خاص (باردار، شیرده، معتاد، مبتلا به بیماری های دیگر و مصرف انسولین) وارد مطالعه نخواهند شد.
زنان و مردان مبتلا به دیابت نوع دو در محدوده سنی 30-60 سال و نمایه توده بدنی 30-24 کیلوگرم بر متر مربع وارد مطالعه خواهند شد. افرادی کهافراد با شرایط خاص (باردار، شیرده، معتاد، مبتلا به بیماری های دیگری باشند، مکمل حاوی انتی اکسیداندیگر و یا مشروبات الکلی مصرف کنند، قند خون کنترل نشده داشته باشند یا انسولین مصرف کنند و یا باردار یا شیرده باشند) وارد مطالعه نخواهند شد.
General information
2018-02-04, 1396/11/15
2018-07-21, 1397/04/30
2018-0207-0421 00:00:00
2018-09-06, 1397/06/15
2018-09-22, 1397/06/31
2018-09-0622 00:00:00
Recruitment centers
#1
Name of recruitment center - English: Diabetes Research Center and Clinics
Name of recruitment center - Persian: مرکز تحقیقاتی درمانی دیابت یزد
Full name of responsible person - English:
Full name of responsible person - Persian:
Street address - English:
Street address - Persian:
City - English: yazd
City - Persian: یزد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Diabetes Research Center and Clinics
Name of recruitment center - Persian: مرکز تحقیقاتی درمانی دیابت یزد
Full name of responsible person - English: Shima abdollahi
Full name of responsible person - Persian: شیما عبداللهی
Street address - English: Shahid Sadoughi Blvd., Diabetes Research Center and Clinics., Yazd
Street address - Persian: يزد ، بلوار شهید صدوقی، مرکز تحقیقات دیابت
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8915173160
Phone: +98 35 3728 0228
Fax:
Email: drc@ssu.ac.ir
Web page address:
Name of recruitment center - English: Diabetes Research Center and Clinics Name of recruitment center - Persian: مرکز تحقیقاتی درمانی دیابت یزد Full name of responsible person - English: Shima abdollahi Full name of responsible person - Persian: شیما عبداللهی Street address - English: Shahid Sadoughi Blvd., Diabetes Research Center and Clinics., Yazd Street address - Persian: يزد ، بلوار شهید صدوقی، مرکز تحقیقات دیابت City - English: yazdYazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8915173160 Phone: +98 35 3728 0228 Fax: Email: drc@ssu.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: shahid sadoughi university of medical science
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Research Associate, School of Public Health
Full name of responsible person - Persian: معاونت پژوهشی دانشکده بهداشت
Street address - English: Yazd - Alam Square - shohadaye gomnam Blvd - Campus of Shahid Sadoughi University of Medical Sciences Yazd - School of Public Health
Street address - Persian: یزد – میدان عالم – بلوار شهدای گمنام – پردیس دانشگاه علوم پزشکی شهید صدوقی یزد – دانشکده بهداشت .
City - English: yazd
City - Persian: یزد
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: Research Associate, School of Public Health
Full name of responsible person - Persian: معاونت پژوهشی دانشکده بهداشت
Street address - English: Shohadaye gomnam Blvd., Campus of Shahid Sadoughi University of Medical Sciences Yazd., School of Public Health
Street address - Persian: یزد، بلوار شهدای گمنام، پردیس دانشگاه علوم پزشکی شهید صدوقی یزد، دانشکده بهداشت .
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8915173160
Phone: +98 35 3820 9100
Fax:
Email: sphealth@ssu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: shahid sadoughi university of medical science Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید صدوقی یزد Full name of responsible person - English: Research Associate, School of Public Health Full name of responsible person - Persian: معاونت پژوهشی دانشکده بهداشت Street address - English: Yazd - Alam Square - shohadayeShohadaye gomnam Blvd -., Campus of Shahid Sadoughi University of Medical Sciences Yazd -., School of Public Health Street address - Persian: یزد – میدان عالم –، بلوار شهدای گمنام –، پردیس دانشگاه علوم پزشکی شهید صدوقی یزد –، دانشکده بهداشت . City - English: yazdYazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8915173160 Phone: +98 35 3820 9100 Fax: Email: sphealth@ssu.ac.ir Web page address:
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#2
contact.organization_id:
Name of organization / entity - English: Iran National Science Foundation
Name of organization / entity - Persian: صندوق حمایت از فناوران و پژوهشگران کشور
Full name of responsible person - English: Nosrat-o-allah Zargham
Full name of responsible person - Persian: دکتر نصرت الله ضرغام
Street address - English: No. 33, Fifth Ave., North Karegar Ave., Tehran.
Street address - Persian: خیابان کارگر شمالی، بعد از تقاطع جلال آل احمد، خیابان پنجم، پلاک 33.
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1439634665
Phone: +98 21 8216 1159
Fax:
Email: medicine@insf.org
Web page address:
contact.organization_id: Name of organization / entity - English: Iran National Science Foundation Name of organization / entity - Persian: صندوق حمایت از فناوران و پژوهشگران کشور Full name of responsible person - English: Nosrat-o-allah Zargham Full name of responsible person - Persian: دکتر نصرت الله ضرغام Street address - English: No. 33, Fifth Ave., North Karegar Ave., Tehran. Street address - Persian: خیابان کارگر شمالی، بعد از تقاطع جلال آل احمد، خیابان پنجم، پلاک 33. City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1439634665 Phone: +98 21 8216 1159 Fax: Email: medicine@insf.org Web page address:
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صندوق حمایت از فناوران و پژوهشگران کشور
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Protocol summary
Study aim
Effects of resveratrol on lipid and glycemic profile indices, expression of PPARα, some factors associated with cell cycle arrest and sCD163 to sTWEAK ration in T2DM patients.
Design
A double blind controlled randomized parallel clinical Trial, will be performed on patients with type 2 diabetes. 72 patients will be randomly assigned to groups receiving resveratrol and the placebo group.
Settings and conduct
The present study will be conducted in a double blind randomized controlled trial. Participants and researchers will not be aware of the supplemental and placebo content. After giving a complete explanation about how the study is done, blood sampling and obtaining informed consent form, a demographic questionnaire will be completed at the beginning of the study. The diet, the level of physical activity, and body composition will be examined using standard methods at the beginning and end of the study. The mRNA expression levels for PPARα, p53, p21 and p16 genes will be assessed using real-time polymerase chain reaction (PCR) and serum CD163 and TWEAK levels will be measured using commercially available ELISA kits at baseline and the end of the study.
Participants/Inclusion and exclusion criteria
Male and female with type 2 diabetes mellitus, aged 30-60 years with a body mass index of 24-30 kg/m2 will be included in the study. Individuals with special conditions (pregnant, lactating, addicted, with other diseases and insulin use) will not be included in the study.
Intervention groups
The intervention and control group will be received capsules containing resveratrol (at a dose of 1000 mg/day) and methyl cellulose (at a dose of 1000 mg / day) respectively, for 8 weeks.
Main outcome variables
Expression values of p16, p21, p53 and PPARα genes; serum levels of sCD163; serum levels of sTWEAK.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171118037528N1
Registration date:2017-12-29, 1396/10/08
Registration timing:prospective
Last update:2018-06-11, 1397/03/21
Update count:4
Registration date
2017-12-29, 1396/10/08
Registrant information
Name
shima abdollahi
Name of organization / entity
shahid sadoughi university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 353820910014
Email address
sh-abdollahi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
shahid sadoughi University of Medical Sciences
Expected recruitment start date
2018-07-21, 1397/04/30
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of resveratrol on lipid and glycemic profile indices, expression of PPARα, some factors associated with cell cycle arrest and sCD163 to sTWEAK ration in T2DM patients.
Public title
Effect of resveratrolon vascular function
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female subjects with established T2DM, who have been diagnosed for at least three months
who have body mass index between 24-30 kgm2,
and aged 30-60 years,
Exclusion criteria:
clinical diagnosis of any liver, kidney, cancer and Alzheimer's diseases
insulin therapy;
HbA1c≥ 8%
consumption of any antioxidant supplements in the last six months
history of allergic reaction to grapes;
consumption of anticoagulants, fibrates and aspirin
drinking red wine and alcohol
history of myocardial infraction
presence of stent or battery in the heart
gastrointestinal ulcer
pregnancy or lactation;
follow the unusual diet until one month before the study;
unwillingness to participation in study
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified blocked randomization method will be used based on sex (male and female) and age (30-45 years and 45-60 years). To assign individuals to the intervention and control groups, a random number table will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements and placebos will be provided in the same appearance and shape and they will be packed in the same bottles, and the only difference will be the letters (A and B) on the bottles. Labels will be affixed to the bottles by someone who is not related to the study. Each bottle contains 120 capsules (for one-month usage). Participants and administrators will be unaware about the contents in the bottles.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Science
Street address
Safaeiye Ave., Alam Square., Shahid Sadoughi University of Medical Science., Yazd.
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2017-10-23, 1396/08/01
Ethics committee reference number
ir.ssu.sph.rec.1396.120
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Proxisome proliferatore activated receptor alpha
Timepoint
Before and after intervention
Method of measurement
Gene expression
2
Description
p53 gene
Timepoint
Before and after intervention
Method of measurement
Gene expression
3
Description
p21 gene
Timepoint
Before and after intervention
Method of measurement
Gene expression
4
Description
p16 gene
Timepoint
Before and after intervention
Method of measurement
Gene expression
5
Description
Soluble Cluster of Differentiation 163
Timepoint
Before and after intervention
Method of measurement
Serum concentration using kit and The enzyme-linked immunosorbent assay method
6
Description
TNF-related weak inducer of apoptosis
Timepoint
Before and after intervention
Method of measurement
Serum concentration using kit and The enzyme-linked immunosorbent assay method
Secondary outcomes
1
Description
Total Triglyceride
Timepoint
Before and after intervention
Method of measurement
Turbidometry
2
Description
Total cholesterol
Timepoint
Before and after intervention
Method of measurement
Turbidometry
3
Description
High density lipoprotein Cholesterol
Timepoint
Before and after intervention
Method of measurement
Turbidometry
4
Description
Low density lipoprotein Cholesterol
Timepoint
Before and after intervention
Method of measurement
Turbidometry
5
Description
Fasting blood glucose
Timepoint
Before and after intervention
Method of measurement
Turbidometry
6
Description
Glycated hemoglobin
Timepoint
Before and after intervention
Method of measurement
Enzymatic kit
7
Description
Fasting insulin
Timepoint
Before and after intervention
Method of measurement
The enzyme-linked immunosorbent assay
Intervention groups
1
Description
Patients in the intervention group will receive two capsules of 500 milligrams of resveratrol per day in 8 weeks.
Category
Prevention
2
Description
Patients in the control group will receive two capsules of 500 milligrams of methyl cellulose per day in 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center and Clinics
Full name of responsible person
Shima abdollahi
Street address
Shahid Sadoughi Blvd., Diabetes Research Center and Clinics., Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3728 0228
Email
drc@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Research Associate, School of Public Health
Street address
Shohadaye gomnam Blvd., Campus of Shahid Sadoughi University of Medical Sciences Yazd., School of Public Health
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
sphealth@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Iran National Science Foundation
Full name of responsible person
Nosrat-o-allah Zargham
Street address
No. 33, Fifth Ave., North Karegar Ave., Tehran.
City
Tehran
Province
Tehran
Postal code
1439634665
Phone
+98 21 8216 1159
Email
medicine@insf.org
Grant name
Grant code / Reference number
۹۶۰۱۰۶۶۰
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran National Science Foundation
Proportion provided by this source
50
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
ُShima Abdollahi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Safaeiye Ave., Alam Square., Shahid Sadoughi University of Medical Science
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2241
Fax
Email
sh-abdollahi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hassan Mozaffari Khosravi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Safaeiye Ave., Alam Square., Public Health faculty., Shahid Sadoughi University of Medical Science
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2241
Fax
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shima Abdollahi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No 13., Moein Ave., Pounak
City
Tehran
Province
Tehran
Postal code
8915173160
Phone
+98 21 4482 9552
Fax
Email
sh.abd6864@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
I have not yet decided on this.
When the data will become available and for how long
I have not yet decided on this.
To whom data/document is available
I have not yet decided on this.
Under which criteria data/document could be used
I have not yet decided on this.
From where data/document is obtainable
I have not yet decided on this.
What processes are involved for a request to access data/document