History
# Registration date Revision Id
2 2019-07-02, 1398/04/11 101541
1 2016-11-23, 1395/09/03 15919
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  • Protocol summary

    This study as a double-blind randomized controlled clinical trial aimed to determine the effects of green cardamom supplementation on blood pressure and endothelium function , blood glucose indices, lipids, oxidant and anti oxidant parameters, sirtuin-1, irisin, oxidised LDL, apolipoprotein A1, B and paraoxonase in type 2 diabetic patients. Totally 80 patients are invited based on inclusion and exclusion criteria. Weight, height and blood pressure are recorded using a digital scale, stadiometer and mercury barometer, respectively. Patients are randomly divided into two groups of 40 people, including placebo group and green cardamom supplementation group for 10 weeks. Green cardamom and placebo (flour breadcrumbs) standardized supplements are prepared as 0.5 gram capsules. 2 capsule per meal should be consumed. A 24-hr recall questionnaire is completed in baseline, after 5 weeks and end of study. Physical activity is assessed using short-form IPAQ (International Physical Activity Questionnaire) at baseline and end of study. Also, 15 ml of blood from the brachial vein of patients are taken to measurement of serum factors at the beginning and end of the study.
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    مطالعه حاضر به صورت کارآزمایی بالینی تصادفی شده دوسوکور شاهد دار با هدف تعیین اثرات مکمل یاری هِل سبز بر فشار خون و برخی زیست نشانگرهای التهابی موثر بر عملکرد اندوتلیال عروقی، قند، چربی، عوامل اکسیدانی، آنتی اکسیدانی، سیرتویین1، آیریزین، لیپوپروتئین با چگالی پایین اکسید شده، آپولیپوپروتئین های ب، آ و پاراکسوناز خون در بیماران مبتلا به دیابت نوع 2 انجام خواهد شد. تعداد 80 بیمار را بر اساس معیاهای ورود و عدم ورود، به مطالعه دعوت می کنیم. وزن، قد و فشار خون بیماران را با استفاده از ترازوی دیجیتال، قدسنج و فشارسنج جیوه ای ثبت می کنیم. بیماران به صورت تصادفی در دو گروه 40 نفری شامل گروه مکمل یاری با هِل و دارونما به مدت ده هفته قرار خواهند گرفت. مکمل های هل و دارونما (پودر سوخاری) به شکل کپسول های نیم گرمی استاندارد سازی شده تهیه می شوند. روزانه 3 گرم مکمل به صورت 2 کپسول نیم گرمی در هر وعده غذایی مصرف خواهد شد. در ابتدا، بعد از 5 هفته و انتهای مطالعه از هر فرد یک یادآمد 24 ساعته جهت بررسی دریافت های غذایی گرفته می شود و فعالیت فیزیکی نیز با استفاده از پرسشنامه بین المللی فعالیت بدنی در ابتدا و انتهای مطالعه بررسی خواهد شد. همچنین، 15 میلی لیتر خون از ورید بازویی بیماران جهت اندازه گیری سطوح سرمی فاکتورهای مورد نظر در ابتدا و انتهای مطالعه گرفته می شود.
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    This study aimed to determine the effects of green cardamom supplementation on blood pressure and endothelium function , blood glucose indices, lipids, oxidant and anti oxidant parameters, sirtuin-1, irisin, oxidised LDL, apolipoprotein A1, B and paraoxonase in type 2 diabetic patients.
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    مطالعه حاضر با هدف تعیین اثرات مکمل یاری هِل سبز بر فشار خون و برخی زیست نشانگرهای التهابی موثر بر عملکرد اندوتلیال عروقی، قند، چربی، عوامل اکسیدانی، آنتی اکسیدانی، سیرتویین1، آیریزین، لیپوپروتئین با چگالی پایین اکسید شده، آپولیپوپروتئین های ب، آ و پاراکسوناز خون در بیماران مبتلا به دیابت نوع 2 انجام خواهد شد.
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    The 83 participants were recruited from the Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute. A total of 83 eligible participants were randomized into two groups using block randomization method. Stratified randomization was used to match participants based on gender (male/female) and BMI (25-29.9/ 30-34.9 kg/m²) into 4 block sizes
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    تعداد 83 بیمار وارد شده به کلینیک تخصصی دیابت بیمارستان شریعتی (شهر تهران) را بر اساس معیارهای ورود و عدم ورود، برای ورود به مطالعه دعوت کردیم. افراد دعوت شده به روش Block Randomization به طور تصادفی به دو گروه تقسیم شدند؛ بدین ترتیب که از بلاک¬های 4 تایی به طور تصادفی (بر اساس جدول اعداد تصادفي) 20 بار به طور تصادفی و با جایگذاری انتخاب شد و حروف بلاک¬های انتخاب شده به دنبال هم نوشته شدند. جهت کنترل متغیر جنس و نمایه توده بدنی از stratified randomization استفاده شد و گروه بندی آن بر اساس جنس (خانم/ آقا) و نمایه توده بدنی (kg/m2 25-9/29 و30-9/34 ) بود.
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    The participants were recruited from the Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences..
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    تعداد 83 بیمار وارد شده به کلینیک تخصصی دیابت بیمارستان شریعتی (شهر تهران) را بر اساس معیارهای ورود و عدم ورود، برای ورود به مطالعه دعوت کردیم.
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    patients aged between 30 to 60 years of age with a body mass index (BMI) 25-34.9 kg/m², and HbA1C value higher than 7% were recruited for this study. The patients should have been diagnosed at least 2 years prior to the study.
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    بيماران ديابتي بين سن 30-60 سال با نمايه توده بدني 25-34.9 و هموگلوبين A1C بالاتر از 7٪ براي اين مطالعه انتخاب شدند. حداقل بايد دوسال از تشخيص ديابت گذشته باشد و تحت درمان با دوز ثابت از داروهاي ضد ديابت باشند.
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    intervention (Cardamom) and placebo ( rusk powder) group.
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    گروه مداخله (هل)و گروه پلاسبو (آرد سوخاري).
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    determine the effects of green cardamom supplementation on blood pressure and endothelium function , blood glucose indices, lipids, oxidant and anti oxidant parameters, sirtuin-1, irisin, oxidised LDL, apolipoprotein A1, B and paraoxonase in type 2 diabetic patients.
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    تعیین اثرات مکمل یاری هِل سبز بر فشار خون و برخی زیست نشانگرهای التهابی موثر بر عملکرد اندوتلیال عروقی، قند، چربی، عوامل اکسیدانی، آنتی اکسیدانی، سیرتویین1، آیریزین، لیپوپروتئین با چگالی پایین اکسید شده، آپولیپوپروتئین های ب، آ و پاراکسوناز خون در بیماران مبتلا به دیابت نوع 2 انجام خواهد شد.
  • General information

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    2017-07-20, 1396/04/29
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    Inclusion criteria Men and women between the age of 30–60 years old who have confirmed diagnosis of type 2 diabetes for more than 2 years; last HbA1C value greater than 7 %; Body Mass Index (BMI) between 25 and 35 kg/m2; Lipid-lowering drugs more than 3 months
    معیارهای ورود به مطالعه: خانم ها و آقایان سن 30 تا 60 سال که بیش از 2 سال از تشخیص دیابتشان گذشته باشد؛ هموگلوبین گلیکوزیله بالاتر از 7%؛ نمایه توده بدنی بین 35 تا 25 (کیلوگرم بر مجذور قد)؛ مصرف داروهای کاهنده چربی خون بیش از 3 ماه
    Exclusion criteria Patients with any of the following criteria will be excluded: being on insulin regimen; use of fibrat(PPAR alpha ligand); TZD (PPAR gamma ligand); Smoking or alcohol consumption at least once a week in the past month; consumption of (at least once a week) herbal supplements; antioxidant; Multivitamin-Mineral in the past 3 months; pregnant and lactating women; have any gastrointestinal disorder, hepatic or renal disease, inflammatory disease, thyroid problems; any Chang in diet during the past 3 months, Consumers of anticoagulants (warfarin , heparin), antiplatelet drugs (Plavix), suppressor CNS (benzodiazepines), barbiturates (phenobarbital), antidepressants.
    معیارهای عدم ورود به مطالعه: مصرف انسولین؛ مصرف فیبرات ها (لیگاند پی پار آلفا)؛ مصرف تیازولیدین دیون ها (لیگاند پی پار گاما)؛ مصرف سیگار یا الکل حداقل یک بار در هفته در ماه گذشته؛ مصرف مرتب (حداقل یک بار در هفته) مکمل های گیاهی، آنتی اکسیدانی، مولتی ویتامین مینرال در 3 ماه گذشته؛ بارداری و شیردهی؛ بیماری های تشخیص داده شده نظیر بیماری های گوارشی، کبدی، کلیوی، بیماری های التهابی، تیروئیدی؛ تغییر رژیم غذایی طی 3 ماه گذشته؛ مصرف کنندگان داروهای ضدانعقادی(وارفارین،هپارین)، داروهای ضد تجمع پلاکتی(پلاویکس)، سرکوب کننده سیستم عصب مرکزی (بنزودیازپین ها)، باربیتورات ها (فنوباربیتال)، داروهای ضد افسردگی.
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    Using block randomization method, in which the assignment was done based on sex (male/female) and BMI (overweight/ obese). By using stratified randomization participants were matched based on sex and BMI into blocks. Therefore, the block size was 4. By using this method equal number of men and women as well as overweight and obese patients were assigned to green cardamom and rusk powder group. Random allocation sequence was generated by using Random allocation software: RAS. The allocation process of participants into cardamom and rusk powder groups was done by a third person who was not involved in the project directly.
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    براساس تصادف سازي بلوك بلندي كه در آن بلوك براساس جنس و نمايه توده بدني بلوك بندي مي شوند و تعداد چهار بلوك بدست مي آيد. و براين اساس تعدادبرابر زن و مرد و هم چنين چاق و اضافه وزن به دو گروه مداخله هل و پلاسبو وارد مي شوند. با استفاده از نرم افزاد RAS براي تخصيص تصادفي استفاده شد. فرايند تخصيص تصادفي توسط يك نفر سوم كه در مطالعه مداخله نداشت انجام شد.
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    In this study is a a randomized, double-blind, placebo controlled clinical trial. The capsules were labeled as A or B to be delivered to the subjects by a third person who was not involved in the project directly and had the job to make the supplements. All placebo capsules were placed close to cardamom capsules to take cardamom smell. For doing this, the supplements were safely capsulated. Then a person who was not involved in the study, packaged the two types of supplements in the plastic bags and placed them close together in a covered box. After one week the capsules were packaged in the small containers to be delivered to the subjects. It was tested to see if the placebo capsules took the smells.
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    اين مطالعه براي محقق كه مسئوليت نمونه گيري و جمع اوري اطلاعات را دارد و شركت كنندگان كور بوده. مكمل هاي مصرفي به صورا A وB بررچسب گذاري شدند توسط نفر سوم كه در مطالعه دخالتي نداشت و وظيفه آماده سازي كپسول ها را داشت. كپسول هاي پلاسبو و هل براي گرفتن بوي هل به مدت يك هفته در كنار هم قرار گرفتند قبل از بسته بندي داخل يك بسته بزرگ در بسته. مكمل هاي پلاسبو براي بررسي گرفتن بوي هل توسط نفر سوم بررسي شدند.
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  • Recruitment centers

    #1
    Name of recruitment center - English: Shariati hospital endocrine clinic
    Name of recruitment center - Persian: کلینیک غدد بیمارستان شریعتی
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Street address - English:
    Street address - Persian:
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Shariati hospital endocrine clinic
    Name of recruitment center - Persian: کلینیک غدد بیمارستان شریعتی
    Full name of responsible person - English: Dr. Ensieh Nasli-Esfahani
    Full name of responsible person - Persian: دكتر انسيه نسلي- اصفهاني
    Street address - English: خ امير آباد
    Street address - Persian: Amirabad Ave
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 000000000
    Phone: +98 21 8894 5247
    Fax:
    Email: n.nasli@yahoo.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Tehran University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Mrs. Rostamabadi
    Full name of responsible person - Persian: خانم رستم آبادی
    Street address - English: First of Qods St, Keshavarz Beulvard
    Street address - Persian: بلوار کشاورز، نبش خ قدس
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Tehran University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Mrs. Rostamabadi
    Full name of responsible person - Persian: خانم رستم آبادی
    Street address - English: First of Qods St, Keshavarz Beulvard
    Street address - Persian: بلوار کشاورز، نبش خ قدس
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 6649 2271
    Fax:
    Email: gsotodeh@tums.ac.ir
    Web page address:
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    Public
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    Domestic
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    Academic
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Nutrition and Dietetics Faculty of Tehran Medical Sciences
    Name of organization / entity - Persian: دانشکده تغذیه و رژیم شناسی علوم پزشکی تهران
    Full name of responsible person - English: Gity Sotoudeh
    Full name of responsible person - Persian: دکتر گیتی ستوده
    Position - English: PhD in Nutritional Sciences
    Position - Persian: دکترای تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No 44, Hojjatdoust alley, Naderi St, Keshavarz Beulvard
    Street address - Persian: بلوار کشاورز، خ نادری، کوچه حجت دوست، پلاک 44
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 8895 5814
    Mobile: +91 23906617
    Fax:
    Email: Gsotodeh@tums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Nutrition and Dietetics Faculty of Tehran Medical Sciences
    Name of organization / entity - Persian: دانشکده تغذیه و رژیم شناسی علوم پزشکی تهران
    Full name of responsible person - English: Gity Sotoudeh
    Full name of responsible person - Persian: دکتر گیتی ستوده
    Position - English: PhD in Nutritional Sciences
    Position - Persian: دکترای تغذیه
    Latest degree: phd
    Area of specialty/work: 15
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No 44, Hojjatdoust alley, Naderi St, Keshavarz Beulvard
    Street address - Persian: بلوار کشاورز، خ نادری، کوچه حجت دوست، پلاک 44
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 8895 5814
    Mobile: +91 23906617
    Fax:
    Email: Gsotodeh@tums.ac.ir
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Nutrition and Dietetics Faculty of Tehran Medical Sciences
    Name of organization / entity - Persian: دانشکده تغذیه و رژیم شناسی علوم پزشکی تهران
    Full name of responsible person - English: Gity Sotoudeh
    Full name of responsible person - Persian: دکتر گیتی ستوده
    Position - English: PhD in Nutritional Sciences
    Position - Persian: پی اچ دی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nutrition and Dietetics Faculty, Hojjatdoust alley, Naderi St, Keshavarz Beulvard
    Street address - Persian: بلوار کشاورز، خیابان نادری، کوچه حجت دوست، دانشکده تغذیه و رژیم شناسی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 8895 5814
    Mobile: +91 23906617
    Fax:
    Email: Gsotodeh@tums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Nutrition and Dietetics Faculty of Tehran Medical Sciences
    Name of organization / entity - Persian: دانشکده تغذیه و رژیم شناسی علوم پزشکی تهران
    Full name of responsible person - English: Gity Sotoudeh
    Full name of responsible person - Persian: دکتر گیتی ستوده
    Position - English: PhD in Nutritional Sciences
    Position - Persian: پی اچ دی
    Latest degree: phd
    Area of specialty/work: 15
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nutrition and Dietetics Faculty, Hojjatdoust alley, Naderi St, Keshavarz Beulvard
    Street address - Persian: بلوار کشاورز، خیابان نادری، کوچه حجت دوست، دانشکده تغذیه و رژیم شناسی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 8895 5814
    Mobile: +91 23906617
    Fax:
    Email: Gsotodeh@tums.ac.ir
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Nutrition and Dietetics Faculty of Tehran Medical Sciences,
    Name of organization / entity - Persian: دانشکده تغذیه و رژیم شناسی علوم پزشکی تهران
    Full name of responsible person - English: Gity Sotoudeh
    Full name of responsible person - Persian: گیتی ستوده
    Position - English: PhD in Nutritional Sciences
    Position - Persian: دکترای 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 Dietetics Faculty, Hojjatdoust alley, Naderi St, Keshavarz Beulvard
    Street address - Persian: بلوار کشاورز- خ نادری- ک حجت دوست- دانشکده تغذیه و رژیم شناسی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 8895 5814
    Mobile: +98 912 390 6617
    Fax:
    Email: gsotodeh@tums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Nutrition and Dietetics Faculty of Tehran Medical Sciences,
    Name of organization / entity - Persian: دانشکده تغذیه و رژیم شناسی علوم پزشکی تهران
    Full name of responsible person - English: Gity Sotoudeh
    Full name of responsible person - Persian: گیتی ستوده
    Position - English: PhD in Nutritional Sciences
    Position - Persian: دکترای علوم تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nutrition and Dietetics Faculty, Hojjatdoust alley, Naderi St, Keshavarz Beulvard
    Street address - Persian: بلوار کشاورز- خ نادری- ک حجت دوست- دانشکده تغذیه و رژیم شناسی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 8895 5814
    Mobile: +98 912 390 6617
    Fax:
    Email: gsotodeh@tums.ac.ir
    Web page address:
  • Sharing plan

    undecided
    yes
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    yes
    undecided
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    No more information available
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    اطلاعات بيشتري وجود ندارد
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    No decision has been made in this case
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    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست
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    access to data few months after results are published
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    در صورت تصميم گيري براي به اشتراك گذاري ، شروع دوره دسترسي چند ماه پس از چاپ نتايج
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    Data are available for researchers
    empty
    در صورت تصميم مثبت براي اشتراك گذاري، داده ها براي محققين دانشگاهي در دسترس مي باشد.
    empty
    If Data are available it would be available for researchers
    empty
    در صورت تصميم مثبت براي اشتراك گذاري، داده ها براي محققين دانشگاهي در دسترس است
    empty
    Dr. Gity Sotoudeh
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    دكتر گيتي ستوده.
    empty
    No decision has been made in this case
    empty
    هنوز تصميمي گرفته نشده است.

Protocol summary

Study aim
This study aimed to determine the effects of green cardamom supplementation on blood pressure and endothelium function , blood glucose indices, lipids, oxidant and anti oxidant parameters, sirtuin-1, irisin, oxidised LDL, apolipoprotein A1, B and paraoxonase in type 2 diabetic patients.
Design
The 83 participants were recruited from the Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute. A total of 83 eligible participants were randomized into two groups using block randomization method. Stratified randomization was used to match participants based on gender (male/female) and BMI (25-29.9/ 30-34.9 kg/m²) into 4 block sizes
Settings and conduct
The participants were recruited from the Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences..
Participants/Inclusion and exclusion criteria
patients aged between 30 to 60 years of age with a body mass index (BMI) 25-34.9 kg/m², and HbA1C value higher than 7% were recruited for this study. The patients should have been diagnosed at least 2 years prior to the study.
Intervention groups
intervention (Cardamom) and placebo ( rusk powder) group.
Main outcome variables
determine the effects of green cardamom supplementation on blood pressure and endothelium function , blood glucose indices, lipids, oxidant and anti oxidant parameters, sirtuin-1, irisin, oxidised LDL, apolipoprotein A1, B and paraoxonase in type 2 diabetic patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2016042717254N5
Registration date: 2016-11-23, 1395/09/03
Registration timing: registered_while_recruiting

Last update: 2019-08-26, 1398/06/04
Update count: 1
Registration date
2016-11-23, 1395/09/03
Registrant information
Name
Gity Sotoude
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3333
Email address
gsotodeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
2016-11-20, 1395/08/30
Actual recruitment end date
2017-07-20, 1396/04/29
Trial completion date
2017-07-20, 1396/04/29
Scientific title
The effects of green cardamom supplementation on blood pressure and endothelium function,blood glucose indices, lipids, oxidant and anti oxidant parameters, sirtuin-1, irisin, oxidised LDL, apolipoprotein A1 and B and paraoxonase in type 2 diabetic patients
Public title
The effects of green cardamom supplementation in type 2 diabetic patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria Men and women between the age of 30–60 years old who have confirmed diagnosis of type 2 diabetes for more than 2 years; last HbA1C value greater than 7 %; Body Mass Index (BMI) between 25 and 35 kg/m2; Lipid-lowering drugs more than 3 months
Exclusion criteria:
Exclusion criteria Patients with any of the following criteria will be excluded: being on insulin regimen; use of fibrat(PPAR alpha ligand); TZD (PPAR gamma ligand); Smoking or alcohol consumption at least once a week in the past month; consumption of (at least once a week) herbal supplements; antioxidant; Multivitamin-Mineral in the past 3 months; pregnant and lactating women; have any gastrointestinal disorder, hepatic or renal disease, inflammatory disease, thyroid problems; any Chang in diet during the past 3 months, Consumers of anticoagulants (warfarin , heparin), antiplatelet drugs (Plavix), suppressor CNS (benzodiazepines), barbiturates (phenobarbital), antidepressants.
Age
From 30 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 80
Actual sample size reached: 83
Randomization (investigator's opinion)
Randomized
Randomization description
Using block randomization method, in which the assignment was done based on sex (male/female) and BMI (overweight/ obese). By using stratified randomization participants were matched based on sex and BMI into blocks. Therefore, the block size was 4. By using this method equal number of men and women as well as overweight and obese patients were assigned to green cardamom and rusk powder group. Random allocation sequence was generated by using Random allocation software: RAS. The allocation process of participants into cardamom and rusk powder groups was done by a third person who was not involved in the project directly.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study is a a randomized, double-blind, placebo controlled clinical trial. The capsules were labeled as A or B to be delivered to the subjects by a third person who was not involved in the project directly and had the job to make the supplements. All placebo capsules were placed close to cardamom capsules to take cardamom smell. For doing this, the supplements were safely capsulated. Then a person who was not involved in the study, packaged the two types of supplements in the plastic bags and placed them close together in a covered box. After one week the capsules were packaged in the small containers to be delivered to the subjects. It was tested to see if the placebo capsules took the smells.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
First of Qods, Keshavarz Beulvard
City
tehran
Province
Tehran
Postal code
14155-6117
Approval date
2015-12-13, 1394/09/22
Ethics committee reference number
IR.TUMS.REC.1394.1388

Health conditions studied

1

Description of health condition studied
diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
FBS
Timepoint
Before intervention, after intervention
Method of measurement
KIT

2

Description
FPI
Timepoint
Before intervention, after intervention
Method of measurement
KIT

3

Description
Hg A1c
Timepoint
Before intervention, after intervention
Method of measurement
kit

4

Description
lipid profile
Timepoint
Before intervention, after intervention
Method of measurement
kit

5

Description
TAC
Timepoint
Before intervention, after intervention
Method of measurement
kit

6

Description
SOD
Timepoint
Before intervention, after intervention
Method of measurement
kit

7

Description
GPx
Timepoint
Before intervention, after intervention
Method of measurement
kit

8

Description
MDA
Timepoint
Before intervention, after intervention
Method of measurement
kit

9

Description
Sirt1
Timepoint
Before intervention, after intervention
Method of measurement
kit

10

Description
Irisin
Timepoint
Before intervention, after intervention
Method of measurement
kit

11

Description
VCAM
Timepoint
Befor intervention, after intervention
Method of measurement
Kit

12

Description
CD-163
Timepoint
Before intervention, after intervention
Method of measurement
kit

13

Description
ADMA
Timepoint
Befor intervention, after intervention
Method of measurement
Kit

14

Description
SBP
Timepoint
Before intervention, middle of intervention, after intervention
Method of measurement
mmhg by mercury manometer

15

Description
OX-LDL
Timepoint
Before intervention, after intervention
Method of measurement
KIT

16

Description
PON
Timepoint
Before intervention, after intervention
Method of measurement
KIT

17

Description
apo A1 - apo B
Timepoint
Before intervention, after intervention
Method of measurement
KIT

18

Description
ICAM
Timepoint
Befor intervention, after intervention
Method of measurement
Kit

19

Description
NO
Timepoint
Befor intervention, after intervention
Method of measurement
Kit

20

Description
TNF-alfa
Timepoint
Befor intervention, after intervention
Method of measurement
Kit

21

Description
IL-6
Timepoint
Befor intervention, after intervention
Method of measurement
Kit

22

Description
hsCRP
Timepoint
Befor intervention, after intervention
Method of measurement
Kit

23

Description
DBP
Timepoint
Befor intervention, middle of intervention,after intervention
Method of measurement
mmhg by mercury manometer

Secondary outcomes

empty

Intervention groups

1

Description
Green cardamom supplements are prepared as 0.5 gram capsules. 2 capsule per meal (3 gram daily) should be consumed for 10 weeks
Category
Placebo

2

Description
placebo (flour breadcrumbs) supplements are prepared as 0.5 gram capsules. 2 capsule per meal (3 gram daily) should be consumed for 10 weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital endocrine clinic
Full name of responsible person
Dr. Ensieh Nasli-Esfahani
Street address
خ امير آباد
City
Tehran
Province
Tehran
Postal code
000000000
Phone
+98 21 8894 5247
Email
n.nasli@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mrs. Rostamabadi
Street address
First of Qods St, Keshavarz Beulvard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Email
gsotodeh@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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 Dietetics Faculty of Tehran Medical Sciences
Full name of responsible person
Gity Sotoudeh
Position
PhD in Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
No 44, Hojjatdoust alley, Naderi St, Keshavarz Beulvard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8895 5814
Fax
Email
Gsotodeh@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nutrition and Dietetics Faculty of Tehran Medical Sciences
Full name of responsible person
Gity Sotoudeh
Position
PhD in Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Nutrition and Dietetics Faculty, Hojjatdoust alley, Naderi St, Keshavarz Beulvard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8895 5814
Fax
Email
Gsotodeh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nutrition and Dietetics Faculty of Tehran Medical Sciences,
Full name of responsible person
Gity Sotoudeh
Position
PhD in Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition and Dietetics Faculty, Hojjatdoust alley, Naderi St, Keshavarz Beulvard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8895 5814
Fax
Email
gsotodeh@tums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
No decision has been made in this case
When the data will become available and for how long
access to data few months after results are published
To whom data/document is available
Data are available for researchers
Under which criteria data/document could be used
If Data are available it would be available for researchers
From where data/document is obtainable
Dr. Gity Sotoudeh
What processes are involved for a request to access data/document
No decision has been made in this case
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