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Effect of oral soft gel containing lemon and cumin essential oil in various doses on weight in subjects with overweight and obesity

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History
# Registration date Revision Id
2 2019-09-27, 1398/07/05 164049
1 2015-03-25, 1394/01/05 12498
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  • Protocol summary

    Objective: The aim of this study is to determine the effect of oral soft gel containing lemon and cumin essential oil in various doses on weight in subjects with BMI≥25. Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Subjects aged 18-50 years with overweight and obesity (BMI≥25) will be included in this study. Individuals with neoplastic, cardiovascular disorders, mal absorptive disorders, current or previous (within the last 6 months) use of hormonal and anti-obesity medications will be excluded in the study. Population and sample size: 105 subjects with overweight and obese eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Subjects will be assigned to receive either oral 25 mg soft gel containing lemon and cumin essential oil (intervention group: n=35), oral 50 mg soft gel containing lemon and cumin essential oil (intervention group: n=35) or placebo (control group: n=35). Subjects' weight will be recorded in baseline and end-of-trial.lemon or placebo pearl will be used 30 minutes before meal and cumin or placebo pearl with meal(3times a day). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure metabolic profiles and thyroid hormones. Start and End Date of Intervention: 8 weeks. Outcomes: Weight, fasting plasma glucose (FPG), serum insulin, lipid profiles and thyroid hormones will be measured in baseline and end-of-trial.
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    هدف: هدف این مطالعه تعیین اثر پرل خوراکی حاوی اسانس لیمو و اسانس زیره با دوزهای مختلف بر روی وزن در افراد با 25 ≤BMI است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور موازی. معیار ورود و خروج مطالعه: افراد 50-18 ساله مبتلا به اضافه وزن و چاقی (25 ≤BMI) در این مطالعه وارد خواهند شد. افراد مبتلا به نئوپلاستیک، اختلالات قلبی-عروقی، اختلالات سوء جذبی، استفاده اخیر یا قبلا (در ظرف 6 ماه گذشته) از هورمون و داروهای ضد چاقی از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 105فرد مبتلا به اضافه وزن و چاق واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: افراد برای دریافت پرل خوراکی حاوی اسانس لیمو و زیره 25 میلیگرم (گروه مداخله: 35=n) یا 50 میلیگرم (گروه مداخله: 35=n)، یا پلاسبو (گروه کنترل: 35=n) تقسیم خواهند شد. پرل لیموترش و پلاسبوی آن نیم ساعت قبل از هر وعده غذایی، و پرل زیره یا پلاسبوی آن همراه غذا مصرف خواهد شد(هرکدام 3 بار در روز). وزن شرکت کنندگان در ابتدا و انتهای مطالعه ثبت خواهد شد. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله برای تعیین پروفایل های متابولیک و هورمون های تیروئیدی از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته . پيامدها: وزن، گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین، پروفایل های لیپیدی و هورمون های تیروئیدی، در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    The aim of this study is to determine the effect of oral soft gel containing lemon and cumin essential oil in various doses on weight in subjects with BMI≥25.
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    هدف این مطالعه تعیین اثر پرل خوراکی حاوی اسانس لیمو و اسانس زیره با دوزهای مختلف بر روی وزن در افراد با 25 ≤BMI است.
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    Parallel double-blind randomized controlled clinical trial.
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    تصادفي کارآزمایی بالینی دو سوکور موازی.
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    72 subjects with overweight and obese eligible and referred to Naghavi Diet Therapy Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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    72 فرد مبتلا به اضافه وزن و چاق واجد شرایط و ارجاع شده به کلینیک رژیم درمانی نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
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    Inclusion criteria: Subjects aged 18 - 50 years with overweight or obesity (BMI ≥ 25 kg/m2). The exclusion criteria will as follows: BMI < 25 kg/m2, subjects with hypertension, thyroid, diabetes or cardiovascular disorders, pregnancy and lactation and the use of hormonal or anti-obesity medications.
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    معیار ورود: افراد 18 تا 50 ساله دارای اضافه وزن یا چاقی ( BMI kg 25 کیلوگرم بر متر مربع) معیارهای عدم ورود به مطالعه به شرح زیر است: BMI <25 کیلوگرم در متر مربع ، افراد مبتلا به فشار خون بالا ، تیروئید ، دیابت یا اختلالات قلبی عروقی ، بارداری و شیردهی و استفاده از داروهای هورمونی یا ضد چاقی.
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    Subjects will be assigned to receive either oral 25 mg soft gel containing lemon and cumin essential oil (intervention group: n=24), oral 75 mg soft gel containing lemon and cumin essential oil (intervention group: n=24) or placebo (control group: n=24).
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    افراد برای دریافت پرل خوراکی حاوی اسانس لیمو و زیره 25 میلی گرم (گروه مداخله: 24=n) یا 75 میلی گرم (گروه مداخله: 24=n)، یا پلاسبو (گروه کنترل: 24=n) تقسیم خواهند شد.
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    Weight, fasting plasma glucose (FPG), serum insulin, insulin resistance, oxidative stress, lipid profiles and thyroid hormones
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    وزن، گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین، مقاومت به انسولین، استرس اکسیداتیو، پروفایل های لیپیدی و هورمون های تیروئیدی

  • General information

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    105
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    2015-08-23, 1394/06/01
    2015-03-30, 1394/01/10
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    Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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    بواسطه کم توجهی، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شده است. اگرچه، اصلاحات صورت گرفته مطابق با یا پروپوزال اصلی تصویب شده یا با هماهنگی معاونت پژوهشی دانشگاه بود.
    Overweight or obesity (BMI ≥ 25 kg/m2)
    Aged 18-50 years
    اضافه وزن یا چاقی (BMIمساوی یا بیشتر از 25)
    سنین 18 تا 50 سال
    BMI < 25 kg/m2
    Hypertension
    Thyroid disorders
    Diabetes
    Cardiovascular disorders
    Pregnancy and lactation
    The use of hormonal or anti-obesity medications
    BMI کمتر مساوی 25
    هایپرتنشن
    اختلالات تیروئیدی
    دیابت
    اختلالات قلبی عروقی
    بارداری و شیردهی
    استفاده از داروهای ضد چاقی و هورمونی
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    At study baseline and after stratification for pre-intervention BMI and age subjects will be randomly divided into three groups to take either high-dose C. cyminum L. and lime supplements (n =24) or low-dose C. cyminum L. and lime supplements (n = 24) or placebo (n = 24). Randomization will be done by the use of computer-generated random numbers.
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    در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن افراد به طور تصادفی به سه گروه برای دریافت مکمل زیره و لیمو با دوز بالا (n = 24) یا مکمل زیره و لیمو با دوز پایین (n = 24) و یا پلاسبو (n = 24) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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    تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
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  • Primary outcomes

    #1
    Fasting plasma glucose
    Body Mass Index
    قند خون ناشتا
    شاخص توده بدن
    Enzymatic
    Calculation using formula
    آنزیمی
    محاسبه با استفاده از فرمول
    #2
    Insulin
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    انسولین
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    Baseline and End-of-trial
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    ابتدا و انتهای مداخله
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    Elisa
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    الایزا
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    #3
    T3
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    T3
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    Baseline and End-of-trial
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    ابتدا و انتهای مداخله
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    Elisa
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    الایزا
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    #4
    T4
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    T4
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    Baseline and End-of-trial
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    ابتدا و انتهای مداخله
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    Elisa
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    الایزا
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    #5
    TSH
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    TSH
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    Baseline and End-of-trial
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    ابتدا و انتهای مداخله
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    Elisa
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    الایزا
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  • Secondary outcomes

    #1
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    Total cholesterol
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    کلسترول تام
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Enzymatic kit
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    کیت آنزیمی
    #2
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    Insulin
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    انسولین
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    ELISA kit
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    کیت الایزا
    #3
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    Triglycerides
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    تری گلیسیرید
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Enzymatic kit
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    کیت آنزیمی
    #4
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    HDL-cholesterol
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    کلسترول HDL
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Enzymatic kit
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    کیت آنزیمی
    #5
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    LDL-cholesterol
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    کلسترول LDL
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Enzymatic kit
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    کیت آنزیمی
    #6
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    Glutathione
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    گلوتاتیون
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Spectrophotometry
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    اسپکتروفتومتری
    #7
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    Total antioxidant capacity
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    ظرفیت آنتی اکسیدانی تام
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Spectrophotometry
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    اسپکتروفتومتری
    #8
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    Fasting blood sugar
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    قند خون ناشتا
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Enzymatic kit
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    کیت آنزیمی
    #9
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    Insulin resistance
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    مقاومت به انسولین
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Calculation using HOMA formula
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    محاسبه با استفاده از فرمول HOMA

  • Intervention groups

    #1
    Intervention group: Oral soft gel containing lemon and cumin essential oil, 25 mg, three times a day, for 8 weeks orally.
    Intervention group: Oral soft gel containing lemon and cumin essential oil, 25 mg, twice a day, for 8 weeks orally.
    گروه مداخله: پرل خوراکی حاوی اسانس لیمو و زیره 25 میلیگرم سه بار در روز(لیمو قبل از غذا، زیره همراه غذا)، به صورت خوراکی برای 8 هفته.
    گروه مداخله: پرل خوراکی حاوی اسانس لیمو و زیره 25 میلیگرم دو بار در روز(لیمو قبل از غذا، زیره همراه غذا)، به صورت خوراکی برای 8 هفته.
    #2
    Intervention group: Oral soft gel containing lemon and cumin essential oil, 50 mg, three times a day, for 8 weeks orally
    Intervention group: Oral soft gel containing lemon and cumin essential oil, 75 mg, twice times a day, for 8 weeks orally
    گروه مداخله: پرل خوراکی حاوی اسانس لیمو و زیره 50 میلی گرم(لیمو قبل از غذا، زیره همراه غذا)، سه بار در روز، به صورت خوراکی برای 8 هفته.
    گروه مداخله: پرل خوراکی حاوی اسانس لیمو و زیره 75میلی گرم (لیمو قبل از غذا، زیره همراه غذا)، دو بار در روز، به صورت خوراکی برای 8 هفته.
    #3
    Control group: Placebo pearl, 6 times a day, for 8 weeks orally.
    Control group: Placebo pearl, twice times a day, for 8 weeks orally.
    گروه کنترل: پرل پلاسبو، 6 بار در روز، به صورت خوراکی برای 8 هفته.
    گروه کنترل: پرل پلاسبو، دو بار در روز، به صورت خوراکی برای 8 هفته.

  • Recruitment centers

    #1
    Name of recruitment center - English: Naghavi Clinic
    Name of recruitment center - Persian: کلینیک نقوی
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Street address - English: Shahid Rajaee Avenue, Kashan
    Street address - Persian: کاشان، خیابان شهید رجایی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Naghavi Clinic
    Name of recruitment center - Persian: کلینیک نقوی
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Street address - English: Shahid Rajaee Avenue, Kashan
    Street address - Persian: کاشان، خیابان شهید رجایی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 31 5530 9223
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Barij Essence Company
    Name of organization / entity - Persian: شرکت داروسازی باریج اسانس
    Full name of responsible person - English: Mohsen Taghizadeh
    Full name of responsible person - Persian: محسن تقی زاده
    Street address - English: Barij Essence Company, Kashan
    Street address - Persian: کاشان، شرکت باریج اسانس
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Barij Essence Company
    Name of organization / entity - Persian: شرکت داروسازی باریج اسانس
    Full name of responsible person - English: Mohsen Taghizadeh
    Full name of responsible person - Persian: محسن تقی زاده
    Street address - English: Barij Essence Company, Kashan
    Street address - Persian: کاشان، شرکت باریج اسانس
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 31 5530 9223
    Fax:
    Email: mohsenta44@yahoo.com
    Web page address:
    Yes
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    Public
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    Domestic
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    Academic
    Barij Essence Company
    Kashan University of Medical Sciences
    شرکت داروسازی باریج اسانس
    دانشگاه علوم پزشکی کاشان

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr.M.Taghizadeh
    Full name of responsible person - Persian: دکتر محسن تقی زاده
    Position - English: PHD
    Position - Persian: دکتری تخصصی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan University Of Medical Sciences, Kashan
    Street address - Persian: کاشان. دانشگاه علوم پزشکی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 36 1555 0021
    Mobile: 00
    Fax:
    Email: taghizadeh_m@kaums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr.M.Taghizadeh
    Full name of responsible person - Persian: دکتر محسن تقی زاده
    Position - English: PHD
    Position - Persian: دکتری تخصصی
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan University Of Medical Sciences, Kashan
    Street address - Persian: کاشان. دانشگاه علوم پزشکی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 36 1555 0021
    Mobile: +98 913 363 3213
    Fax:
    Email: taghizadeh_m@kaums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr Zatollah Asemi
    Full name of responsible person - Persian: دکتر ذات الله عاصمی
    Position - English: PHD
    Position - Persian: دکتری تخصصی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan University Of Medical Sciences, Kashan
    Street address - Persian: کاشان. دانشگاه علوم پزشکی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 36 1555 0021
    Mobile: 00
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Zatollah Asemi
    Full name of responsible person - Persian: دکتر ذات الله عاصمی
    Position - English: PHD
    Position - Persian: دکتری تخصصی
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan University Of Medical Sciences, Kashan
    Street address - Persian: کاشان. دانشگاه علوم پزشکی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 36 1555 0021
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Barij Research Center of Medicinal Herbs
    Name of organization / entity - Persian: مرکز تحقیقات گیاهان دارویی باریج
    Full name of responsible person - English: M.Mahlouji
    Full name of responsible person - Persian: خانم مهناز محلوجی
    Position - English: Clinical Expert
    Position - Persian: کارشناس بالینی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan Mashhad Ardehal Road, KM44
    Street address - Persian: کیلومتر 44 جاده کاشان-مشهد اردهال
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: 00
    Mobile: 00
    Fax:
    Email: mahnaz.mahlouji@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Barij Research Center of Medicinal Herbs
    Name of organization / entity - Persian: مرکز تحقیقات گیاهان دارویی باریج
    Full name of responsible person - English: M.Mahlouji
    Full name of responsible person - Persian: خانم مهناز محلوجی
    Position - English: Clinical Expert
    Position - Persian: کارشناس بالینی
    Latest degree: phd
    Area of specialty/work: 84
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan Mashhad Ardehal Road, KM44
    Street address - Persian: کیلومتر 44 جاده کاشان-مشهد اردهال
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 31 5562 0608
    Mobile: +98 913 363 3213
    Fax:
    Email: mahnaz.mahlouji@yahoo.com
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    Undecided - It is not yet known if there will be a plan to make this available
    empty
    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست

Protocol summary

Study aim
The aim of this study is to determine the effect of oral soft gel containing lemon and cumin essential oil in various doses on weight in subjects with BMI≥25.
Design
Parallel double-blind randomized controlled clinical trial.
Settings and conduct
72 subjects with overweight and obese eligible and referred to Naghavi Diet Therapy Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Subjects aged 18 - 50 years with overweight or obesity (BMI ≥ 25 kg/m2). The exclusion criteria will as follows: BMI < 25 kg/m2, subjects with hypertension, thyroid, diabetes or cardiovascular disorders, pregnancy and lactation and the use of hormonal or anti-obesity medications.
Intervention groups
Subjects will be assigned to receive either oral 25 mg soft gel containing lemon and cumin essential oil (intervention group: n=24), oral 75 mg soft gel containing lemon and cumin essential oil (intervention group: n=24) or placebo (control group: n=24).
Main outcome variables
Weight, fasting plasma glucose (FPG), serum insulin, insulin resistance, oxidative stress, lipid profiles and thyroid hormones

General information

Reason for update
Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
Acronym
IRCT registration information
IRCT registration number: IRCT2015030812438N10
Registration date: 2015-03-25, 1394/01/05
Registration timing: registered_while_recruiting

Last update: 2020-12-22, 1399/10/02
Update count: 1
Registration date
2015-03-25, 1394/01/05
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Essence Company
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-03-30, 1394/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral soft gel containing lemon and cumin essential oil in various doses on weight in subjects with overweight and obesity
Public title
Effect of cumin and lemon on obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight or obesity (BMI ≥ 25 kg/m2) Aged 18-50 years
Exclusion criteria:
BMI < 25 kg/m2 Hypertension Thyroid disorders Diabetes Cardiovascular disorders Pregnancy and lactation The use of hormonal or anti-obesity medications
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI and age subjects will be randomly divided into three groups to take either high-dose C. cyminum L. and lime supplements (n =24) or low-dose C. cyminum L. and lime supplements (n = 24) or placebo (n = 24). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan
City
Bolvare Ghotbe Ravandi, Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2015-02-28, 1393/12/09
Ethics committee reference number
93210

Health conditions studied

1

Description of health condition studied
Overweight and Obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Weight
Timepoint
Baseline and End-of-trial
Method of measurement
scale

2

Description
Body Mass Index
Timepoint
Baseline and End-of-trial
Method of measurement
Calculation using formula

Secondary outcomes

1

Description
Total cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

2

Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
ELISA kit

3

Description
Triglycerides
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

4

Description
HDL-cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

5

Description
LDL-cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

6

Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

7

Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

8

Description
Fasting blood sugar
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

9

Description
Insulin resistance
Timepoint
Baseline and End-of-trial
Method of measurement
Calculation using HOMA formula

Intervention groups

1

Description
Intervention group: Oral soft gel containing lemon and cumin essential oil, 25 mg, twice a day, for 8 weeks orally.
Category
Treatment - Drugs

2

Description
Intervention group: Oral soft gel containing lemon and cumin essential oil, 75 mg, twice times a day, for 8 weeks orally
Category
Treatment - Drugs

3

Description
Control group: Placebo pearl, twice times a day, for 8 weeks orally.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5530 9223
Email
asemi_r@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Barij Essence Company
Full name of responsible person
Mohsen Taghizadeh
Street address
Barij Essence Company, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5530 9223
Email
mohsenta44@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr.M.Taghizadeh
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
Email
taghizadeh_m@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Zatollah Asemi
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
M.Mahlouji
Position
Clinical Expert
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5562 0608
Fax
Email
mahnaz.mahlouji@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
Undecided - It is not yet known if there will be 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
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
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