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The effect of boron citrate supplementation on nutritional status, cardiometabolic factors, and inflammatory indices of TNF-α, IL-10, IL-6, and CRP in obese people

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History
# Registration date Revision Id
4 2024-05-01, 1403/02/12 312965
3 2023-03-19, 1401/12/28 260744
2 2022-09-17, 1401/06/26 240736
1 2022-08-31, 1401/06/09 238397
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  • General information

    Treatment
    Prevention
    2022-12-18, 1401/09/27
    2023-06-20, 1402/03/30
    2023-03-18, 1401/12/27
    2023-12-21, 1402/09/30
    30= Willingness to participate in the study
    BMI: 30–40 (kg/m²)
    Willingness to participate in the study
    شاخص توده بدنی (BMI) بزرگتر مساوی 30 و کوچکتر مساوی 40
    تمایل به شرکت در مطالعه
    شاخص توده بدنی (BMI) : 30-40 بر حسب کیلوگرم بر مجذور قد بر حسب متر
    تمایل به شرکت در مطالعه
    Stratified permuted block randomization will be applied to stratify participants into different stratum and blocks based on gender and probable confounders including age and BMI. Each block will be randomly allocated to the intervention or control groups. The sequence of the blocks will be prepared for each stratum Random Allocation Software (RAS). For each patient in a definite block, a matched person in terms of the aforementioned variables would be considered in that block. Participants and investigators will be blind to the trial group assignments until the end of the study and data analysis.
    To stratify individuals into distinct strata and blocks, stratified block randomization will be implemented based on age (18-40 vs. 40-60 years) and gender (male vs. female). For each individual placed in a given stratum, a matched individual is considered based on these variables in the same stratum. As a result, two participants with similar characteristics (for age and gender) are placed in the same stratum. Finally, each stratum will be randomly allocated to the intervention or control groups using Random Allocation Software (RAS). Participants and researchers will be blinded to the randomization and allocation until the end of the study. The randomization list will be provided by the pharmacist of the research center at the end of the study.
    تصادفی‌سازی بلوک‌های جایگشتی طبقه‌ای برای طبقه‌بندی شرکت‌کنندگان به بلوک‌های مختلف بر اساس جنسیت و عوامل مخدوش‌کننده احتمالی از جمله سن و BMI اعمال خواهد شد. هر بلوک به صورت تصادفی به گروه مداخله یا کنترل اختصاص داده می‌شود. توالی بلوک‌ها برای هر طبقه نرم افزار تخصیص تصادفی (RAS) آماده می‌شود. برای هر بیمار در یک بلوک معین، یک فرد منطبق بر حسب متغیرهای فوق الذکر در آن بلوک در نظر گرفته می شود. شرکت کنندگان و محققین تا پایان مطالعه و تجزیه و تحلیل داده‌ها نسبت به نوع گروه کارآزمایی کور خواهند بود.
    برای طبقه‌بندی افراد به طبقات و بلوک‌های مجزا، تصادفی‌سازی بلوک‌ طبقه‌ بندی شده بر اساس سن (40-18 در مقابل 60-40 سال) و جنسیت (مرد در مقابل زن) اجرا می‌شود. برای هر فردی که در یک طبقه معین قرار می گیرد، یک فرد همسان بر اساس این متغیرها در همان طبقه در نظر گرفته می شود. در نتیجه، دو شرکت‌کننده با ویژگی‌های مشابه (از نظر سن و جنسیت) در یک طبقه قرار می‌گیرند. در نهایت هر طبقه با استفاده از نرم افزار تخصیص تصادفی (RAS) به طور تصادفی به گروه های مداخله یا کنترل تخصیص داده می شود. شرکت کنندگان و محققان تا پایان مطالعه نسبت به تخصیص گروه ها کور خواهند بود. لیست تصادفی سازی توسط داروساز مرکز تحقیقات در پایان مطالعه ارائه خواهد شد.
    In order to blind all the investigators and participants, an individual not involved in the trial will make a randomized list assignment for the participants in each group and will label all the identical containers (in appearance and color) based on their numbers. Therefore, the participants will be unaware of the type of intervention they receive. The random sequence will be unpredictable, as well.
    In this study, patients and researchers will be blind to the type of supplements (boron citrate or placebo). The person responsible for preparing the supplement packages (a person completely unrelated to the study) will be asked to assign a three-digit code to each of the two received supplements (boron citrate or placebo) and keep the codes for himself until the end of the study.
    به منظور کور کردن همه محققین و شرکت کنندگان، فردی که در کارآزمایی شرکت ندارد، یک لیست تصادفی برای شرکت کنندگان در هر گروه تعیین می‌کند و همه ظروف یکسان (از نظر ظاهر و رنگ) را بر اساس شماره آنها برچسب گذاری می‌کند. بنابراین شرکت کنندگان از نوع مداخله‌ای که دریافت می‌کنند بی‌اطلاع خواهند بود. توالی تصادفی نیز غیر قابل پیش‌بینی خواهد بود.
    در این مطالعه بیماران و محقق از نوع مکمل دریافتی ( بورون سیترات یا دارونما) بی اطلاع خواهند بود. از فرد مسئول آماده سازی بسته های مکمل ( فردی کاملا غیر مرتبط با مطالعه است) در خواست خواهد شد که به هر کدام از دو مکمل دریافتی (بورون سیترات یا دارونما) یک کد سه رقمی اختصاص داده و تا پایان مطالعه کدها را نزد خود محفوظ نگه دارد.

  • Primary outcomes

    #1
    energy consumption
    weight
    میزان دریافت انرژی
    وزن
    questionnaire
    weight scale
    پرسشنامه
    ترازو
    #2
    macronutrient consumption
    body mass scale
    دریافت درشت مغذی‌ها
    شاخص توده بدنی
    questionnaire
    Calculation based on formula
    پرسشنامه
    محاسبه بر اساس فرمول
    #3
    weight
    waist circumstance
    وزن
    دور کمر
    weight scale
    tape measure
    ترازو
    متر نواری
    #4
    body mass scale
    waist to hio ratio
    شاخص توده بدنی
    نسبت دور کمر به دور باسن
    weight scale and stadiometer
    Calculation based on formula
    ترازو و استادیومتر
    محاسبه بر اساس فرمول
    #5
    waist circumstance
    waist circumstance to height ratio
    دور کمر
    نسبت دور کمر به قد
    tape measure
    Calculation based on formula
    متر نواری
    محاسبه بر اساس فرمول
    #6
    waist to hio ratio
    CRP (c-reactive protein)
    نسبت دور کمر به دور باسن
    پروتئین واکنشی C
    tape measure
    ELISA
    متر نواری
    الایزا
    #7
    waist circumstance to height ratio
    TNF-α (Tumor necrosis factor-α)
    نسبت دور کمر به قد
    فاکتور نکروز دهنده تومور آلفا
    tape measure and stadiometer
    ELISA
    متر نواری و استادیومتر
    الایزا
    #8
    blood glucose
    IL-10
    قند خون
    اینترلوکین-10
    #9
    Insulin
    IL-6
    انسولین
    اینترلوکین-6
    #10
    HbA1C
    total body fat mass (FM)
    هموگلوبین A1C
    توده چربی کل بدن
    ELISA
    bioelectrical impedance analysis
    الایزا
    آنالیز امپدانس بیوالکتریک
    #11
    Insulin resistance with HOMA-IR score
    total body fat‐free mass (FFM)
    مقاومت انسولینی با امتیاز HOMA-IR
    توده بدون چربی کل بدن
    ELISA
    bioelectrical impedance analysis
    الایزا
    آنالیز امپدانس بیوالکتریک
    #12
    LDL-c
    hip circumference
    کلسترول LDL
    دور باسن
    ELISA
    tape measure
    الایزا
    متر نواری
    #13
    HDL-c
    empty
    کلسترول HDL
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    ELISA
    empty
    الایزا
    empty
    #14
    total cholesterol
    empty
    کلسترول تام
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    ELISA
    empty
    الایزا
    empty
    #15
    triglicerid
    empty
    تری‌گلیسیرید
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    ELISA
    empty
    الایزا
    empty
    #16
    systolic blood pressure
    empty
    فشار خون سیستولی
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    mercury manometer
    empty
    فشارسنج جیوه‌ای
    empty
    #17
    diastolic blood pressure
    empty
    فشار خون دیاستولی
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    mercury manometer
    empty
    فشارسنج جیوه‌ای
    empty
    #18
    CRP (c-reactive protein)
    empty
    پروتئین واکنشی C
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Elisa
    empty
    الایزا
    empty
    #19
    TNF-α (Tumor necrosis factor-α)
    empty
    فاکتور نکروز دهنده تومور آلفا
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    gene expression measurement with RT-PCR method
    empty
    اندازه گیری بیان ژن به روش RT-PCR
    empty
    #20
    IL-10
    empty
    اینترلوکین-10
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    gene expression measurement with RT-PCR method
    empty
    اندازه گیری بیان ژن به روش RT-PCR
    empty
    #21
    IL-6
    empty
    اینترلوکین-6
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    gene expression measurement with RT-PCR method
    empty
    اندازه گیری بیان ژن به روش RT-PCR
    empty

  • Secondary outcomes

    #1
    Body composition
    energy consumption
    درصد ترکیب بدنی
    میزان دریافت انرژی
    Before intervention, and 3 months after intervention
    Beginning and end of the trial
    قبل مداخله و سه ماه پس از شروع مداخله
    ابتدا و انتهای مطالعه
    Measurement of body composition, including fat mass, fat free mass and total body water determination using bioelectrical impedance analyser (BIA)
    Questionnaire
    اندازه گیری ترکیب بدن شامل توده چربی، توده بدون چربی و آب کل بدن با استفاده از دستگاه bioelectrical impedence analyser (BIA)
    پرسشنامه
    #2
    empty
    macronutrient consumption
    empty
    دریافت درشت مغذی‌ها
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Questionnaire
    empty
    پرسشنامه
    #3
    empty
    blood glucose
    empty
    قند خون
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Use of an enzymatic kit method
    empty
    روش آنزیماتیک با استفاده از کیت
    #4
    empty
    Fasting insulin levels
    empty
    سطوح انسولین ناشتا
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    ELISA
    empty
    الایزا
    #5
    empty
    Insulin resistance with HOMA-IR score
    empty
    مقاومت انسولینی با امتیاز HOMA-IR
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Calculation based on formula
    empty
    محاسبه بر اساس فرمول
    #6
    empty
    LDL-c
    empty
    کلسترول LDL
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Calculation based on the Friedewald formula
    empty
    محاسبه بر اساس فرمول Friedewald
    #7
    empty
    HDL-c
    empty
    کلسترول HDL
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Use of an enzymatic kit method
    empty
    روش آنزیماتیک با استفاده از کیت
    #8
    empty
    total cholesterol
    empty
    کلسترول تام
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Use of an enzymatic kit method
    empty
    روش آنزیماتیک با استفاده از کیت
    #9
    empty
    Triglyceride
    empty
    تری‌گلیسیرید
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Use of an enzymatic kit method
    empty
    روش آنزیماتیک با استفاده از کیت
    #10
    empty
    systolic blood pressure
    empty
    فشار خون سیستولی
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    mercury manometer
    empty
    فشارسنج جیوه‌ای
    #11
    empty
    diastolic blood pressure
    empty
    فشار خون دیاستولی
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    mercury manometer
    empty
    فشارسنج جیوه‌ای
    #12
    empty
    QUICKI
    empty
    شاخص بررسی کمی حساسیت به انسولین
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Calculation based on formula
    empty
    محاسبه بر اساس فرمول

  • Intervention groups

    #1
    Intervention group: This study is a double-blind placebo-controlled randomized clinical trial among volunteer obese patients who are willing to participate in the study by calling, after initial screening and checking the inclusion criteria, with The explanation regarding the purpose and method of studying the informed consent form will be completed. Then, during an interview with the participants, a personal profile questionnaire including (age, sex, job, education level, history of diseases, supplements and drugs, history of following a special diet, etc.), activity questionnaire validated body in Persian language IPAQ) and a three-day dietary recall form (two regular days and one day off of the week) at the beginning and end of the study and dietary data after converting to daily intake values ​​to determine energy and macronutrients will be analyzed using Nutritionist IV software. Anthropometric measurements including height and weight will be measured at the beginning and once every two weeks until the end of the study. People's height was measured using a Seca stadiometer with an accuracy of 0.1 cm, their weight was measured using a Seca weighing scale with an accuracy of 100 grams (with minimal clothes and no shoes), and then waist circumference, waist circumference Hips and waist circumference will be estimated by standing height BMI. At the beginning and end of the study, 10 cc of blood will be taken from the subjects after 12 hours of fasting and the serum will be stored at -70°C until the time of measurement.Serum samples will be used to measure glycemic indices, lipid profile, liver enzymes. After 15 minutes of rest, people's blood pressure will be measured twice with an interval of 5 minutes, and the average blood pressure will be taken into account. Then, for randomly assigning people to two groups of 30 people, using RAS software, and based on 4 random blocks, people will be placed in intervention and control groups.The supplement group will take one boron tablet (1 capsule containing 10 mg of boron citrate per day before lunch) and the placebo group will take one tablet containing maltodextrin powder (before lunch) for 8 weeks.The pill containing the supplement and the placebo used in this study will be completely identical in appearance. The intervention group will receive tablets containing boron citrate supplement.
    Intervention group: Patients in this group will receive dietary recommendations and boron citrate capsules including 10 mg boron for 12 weeks. Boron citrate capsules is made in Iran, and once a day before lunch will be consumed.
    گروه مداخله: این مطالعه به صورت کارآزمایی بالینی تصادفی کنترل شده با دارونما دو سو کور در بین بیماران چاق از میان داوطلبان با استفاده از فراخوان که تمایل به شرکت در مطالعه را داشته باشند، بعد از غربالگری اولیه و بررسی معیارهای ورود به مطالعه، با توضیح در خصوص هدف و نحوه اجری مطالعه فرم رضایت نامه آگاهانه تکمیل خواهد شد. سپس طی مصاحبه ای با افراد شرکت کننده پرسشنامه مشخصات فردی شامل (سن، جنس، شغل، سطح تحصیلات، سابقه‌ی بیماری‌ها، مکمل‌ها و داروهای مصرفی، سابقه پیروی از رژیم غذایی خاص و ...)، پرسشنامه فعالیت بدنی اعتبار سنجی شده به زبان فارسی IPAQ)) و فرم یادآمد سه روزه غذایی (دو روز معمول و یک روز تعطیل هفته) در ابتدا و انتهای مطالعه تکمیل و داده‌های غذایی پس از تبدیل به مقادیر دریافتی روزانه برای تعیین انرژی و درشت‌مغذی‌ها با استفاده از نرم‌افزار Nutritionist IV آنالیز خواهد شد. اندازه‌گیری‌های تن سنجی شامل قد و وزن در ابتدا و هر دو هفته یک بار وزن تا انتهای مطالعه اندازه گیری خواهد شد. قد افراد با استفاده از قدسنج Seca با دقت 1/0 سانتیمتر، وزن آنها با استفاده از ترازوی فنری Seca با دقت 100 گرم (با حداقل لباس و بدون کفش) اندازه‌گیری، و سپس و دور کمر, دور کمر به دور باسن و دور کمر به قد ایستاده BMI برآورد خواهد شد. در ابتدا و انتهای مطالعه، از افراد 10 سی‌سی خون بعد از 12 ساعت ناشتایی گرفته شده و سرم تا زمان اندازه گیری در 70- درجه سانتی گراد ذخیره خواهد شد. نمونه های سرمی جهت سنجش شاخص‌های گلیسمی، الگوی لیپیدی و آنزیم‌های کبدی مورد استفاده قرار خواهند گرفت. فشارخون افراد بعد از 15 دقیقه استراحت، 2 بار با فاصله 5 دقیقه اندازه‌گیری خواهد شد و میانگین فشار خون لحاظ خواهد شد. سپس براي تخصیص تصادفي افراد به دو گروه 30 نفره ی استفاده از نرم افزار RAS و بر اساس بلوك هاي 4 تایی تصادفي، افراد در گروه‌هاي مداخله و كنترل قرار خواهد گرفت.گروه مکمل یک قرص بور (1 عدد کپسول حاوی 10 میلی گرم بورون سیترات در روز قبل از نهار) و افراد گروه دارونما یک قرص حاوی پودر مالتودکسترین (قبل از نهار) به مدت 8 هفته میل خواهند کرد. قرص حاوی مکمل و دارونمای مورد استفاده در این مطالعه از لحاظ ظاهری کاملاً مشابه خواهند بود. گروه مداخله قرص حاوی مکمل بور سیترات را دریافت خواهند نمود.
    گروه مداخله: بیماران در این گروه توصیه های تغذیه ای را همراه با کپسول بورون سیترات حاوی 10 میلی‌گرم بورون به مدت 12 هفته دریافت خواهند کرد.مکمل بورون سیترات ( ساخت کشور ایران) است و یک بار در روز قبل ناهار مصرف خواهد شد.
    #2
    Placebo
    Prevention
    Control group: This study is a double-blind placebo-controlled randomized clinical trial among volunteer obese patients who are willing to participate in the study by calling, after initial screening and checking the inclusion criteria, with The explanation regarding the purpose and method of studying the informed consent form will be completed. Then, during an interview with the participants, a personal profile questionnaire including (age, sex, job, education level, history of diseases, supplements and drugs, history of following a special diet, etc.), activity questionnaire validated body in Persian language IPAQ) and a three-day dietary recall form (two regular days and one day off of the week) at the beginning and end of the study and dietary data after converting to daily intake values ​​to determine energy and macronutrients will be analyzed using Nutritionist IV software. Anthropometric measurements including height and weight will be measured at the beginning and once every two weeks until the end of the study. People's height was measured using a Seca stadiometer with an accuracy of 0.1 cm, their weight was measured using a Seca weighing scale with an accuracy of 100 grams (with minimal clothes and no shoes), and then waist circumference, waist circumference Hips and waist circumference will be estimated by standing height BMI. At the beginning and end of the study, 10 cc of blood will be taken from the subjects after 12 hours of fasting and the serum will be stored at -70°C until the time of measurement. Serum samples will be used to measure glycemic indices, lipid profile, liver enzymes. After 15 minutes of rest, people's blood pressure will be measured twice with an interval of 5 minutes, and the average blood pressure will be taken into account. Then, for randomly assigning people to two groups of 30 people, using RAS software, and based on 4 random blocks, people will be placed in intervention and control groups. The supplement group will take one boron tablet (1 capsule containing 10 mg of boron citrate per day before lunch) and the placebo group will take one tablet containing maltodextrin powder (before lunch) for 8 weeks. The pill containing the supplement and the placebo used in this study will be completely identical in appearance. The control group will receive tablets containing maltodextrin as placebo.
    Control group: Patients in this group will receive dietary recommendations with placebo for 12 weeks. The placebo is starch (containing 10 mg of maltodextrin) and once a day before lunch will be consumed.
    گروه کنترل: این مطالعه به صورت کارآزمایی بالینی تصادفی کنترل شده با دارونما دو سو کور در بین بیماران چاق از میان داوطلبان با استفاده از فراخوان که تمایل به شرکت در مطالعه را داشته باشند، بعد از غربالگری اولیه و بررسی معیارهای ورود به مطالعه، با توضیح در خصوص هدف و نحوه اجری مطالعه فرم رضایت نامه آگاهانه تکمیل خواهد شد. سپس طی مصاحبه ای با افراد شرکت کننده پرسشنامه مشخصات فردی شامل (سن، جنس، شغل، سطح تحصیلات، سابقه‌ی بیماری‌ها، مکمل‌ها و داروهای مصرفی، سابقه پیروی از رژیم غذایی خاص و ...)، پرسشنامه فعالیت بدنی اعتبار سنجی شده به زبان فارسی IPAQ)) و فرم یادآمد سه روزه غذایی (دو روز معمول و یک روز تعطیل هفته) در ابتدا و انتهای مطالعه تکمیل و داده های غذایی پس از تبدیل به مقادیر دریافتی روزانه برای تعیین انرژی و درشت مغذی ها با استفاده از نرم‌افزار Nutritionist IV آنالیز خواهد شد. اندازه گیری های تن سنجی شامل قد و وزن در ابتدا و هر دو هفته یک بار وزن تا انتهای مطالعه اندازه گیری خواهد شد. قد افراد با استفاده از قدسنج Seca با دقت 1/0 سانتی‌متر، وزن آنها با استفاده از ترازوی فنری Seca با دقت 100 گرم (با حداقل لباس و بدون کفش) اندازه‌گیری، و سپس و دور کمر, دور کمر به دور باسن و دور کمر به قد ایستاده BMI برآورد خواهد شد. در ابتدا و انتهای مطالعه، از افراد 10 سی‌سی خون بعد از 12 ساعت ناشتایی گرفته شده و سرم تا زمان اندازه گیری در 70- درجه سانتی گراد ذخیره خواهد شد. نمونه های سرمی جهت سنجش شاخص های گلیسمی، الگوی لیپیدی، آنزیم های کبدی مورد استفاده قرار خواهند گرفت. فشارخون افراد بعد از 15 دقیقه استراحت، 2 بار با فاصله 5 دقیقه اندازه گیری خواهد شد و میانگین فشار خون لحاظ خواهد شد. سپس براي تخصیص تصادفي افراد به دو گروه 30 نفره ی استفاده از نرم افزار RAS و بر اساس بلوك هاي 4 تایی تصادفي، افراد در گروه‌هاي مداخله و كنترل قرار خواهد گرفت.گروه مکمل یک قرص بور (1 عدد کپسول حاوی 10 میلی گرم بورون سیترات در روز قبل از نهار) و افراد گروه دارونما یک قرص حاوی پودر مالتودکسترین (قبل از نهار) به مدت 8 هفته میل خواهند کرد. قرص حاوی مکمل و دارونمای مورد استفاده در این مطالعه از لحاظ ظاهری کاملاً مشابه خواهند بود. گروه کنترل قرص حاوی مالتودکسترین را به عنوان دارونما دریافت خواهند نمود.
    گروه کنترل: روه کنترل: بیماران در این گروه توصیه های تغذیه ای را همراه با دارونما به مدت 12 هفته دریافت خواهند کرد. دارونما عبارت است از نشاسته (حاوی 10 میلی‌گرم مالتودکسترین) و یک بار در روز قبل ناهار مصرف خواهد شد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Health centers of Tabriz University of Medical Sciences
    Name of recruitment center - Persian: مراکز درمانی دانشگاه علوم پزشکی تبریز
    Full name of responsible person - English: Helda Tutunchi
    Full name of responsible person - Persian: هلدا توتونچی
    Street address - English: Ground Floor of Nutrition faculty, Tabriz University of Medical Science, Golgasht Avenue, Attar Neyshabouri Street
    Street address - Persian: خیابان عطار نیشابوری، خیابان گلگشت، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه، طبقه همکف
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 914 116 3184
    Fax:
    Email: helda.nutrition@gmail.com
    Web page address:
    Name of recruitment center - English: Nutrition Research Center of Tabriz University of Medical Sciences
    Name of recruitment center - Persian: مرکز تحقیقات تغذیه دانشگاه علوم پزشکی تبریز
    Full name of responsible person - English: Helda Tutunchi
    Full name of responsible person - Persian: هلدا توتونچی
    Street address - English: Nutrition faculty, Tabriz University of Medical Science, Golgasht Avenue, Attar Neyshabouri Street
    Street address - Persian: خیابان عطار نیشابوری، خیابان گلگشت، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 914 116 3184
    Fax:
    Email: helda.nutrition@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Tabriz University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
    Full name of responsible person - English: Dr. Parviz Shahabi
    Full name of responsible person - Persian: دکتر پرویز شهابی
    Street address - English: Nutrition Faculty, Attar Neishabouri Street, Golgasht Avenue
    Street address - Persian: خیابان گلگشت، خیابان عطار نیشابوری، دانشکده تغذیه
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 914 116 3184
    Fax:
    Email: helda.nutrition@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Tabriz University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
    Full name of responsible person - English: Dr. Parviz Shahabi
    Full name of responsible person - Persian: دکتر پرویز شهابی
    Street address - English: Tabriz University of Medical Sciences, Attar Neishabouri Street, Golgasht Avenue
    Street address - Persian: خیابان گلگشت، خیابان عطار نیشابوری، دانشگاه علوم پزشکی تبریز
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3335 7580
    Fax:
    Email: parvizshahabi@gmail.com
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Helda Tutunchi
    Full name of responsible person - Persian: هلدا توتونچی
    Position - English: Assistant Professor of Nutritional Sciences
    Position - Persian: استادیار 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: Attar - e - Neyshabouri
    Street address - Persian: عطار نیشابوری
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 914 116 3184
    Mobile: +98 914 116 3184
    Fax:
    Email: helda.nutrition@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Helda Tutunchi
    Full name of responsible person - Persian: هلدا توتونچی
    Position - English: Assistant Professor of Nutritional Sciences
    Position - Persian: استادیار 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 Faculty, Attar Neyshabouri Avenue, Golgasht Street
    Street address - Persian: خیابان گلگشت، خیابان عطار نیشابوری، دانشکده تغذیه
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3335 7580
    Mobile: +98 914 116 3184
    Fax:
    Email: helda.nutrition@gmail.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Helda Tutunchi
    Full name of responsible person - Persian: هلدا توتونچی
    Position - English: Assistant Professor of Nutritional Sciences
    Position - Persian: استادیار 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: Attar - e - Neyshabouri
    Street address - Persian: عطار نیشابوری
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 914 116 3184
    Mobile: +98 914 116 3184
    Fax:
    Email: helda.nutrition@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Helda Tutunchi
    Full name of responsible person - Persian: هلدا توتونچی
    Position - English: Assistant Professor of Nutritional Sciences
    Position - Persian: استادیار 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 Faculty, Attar Neyshabouri Avenue, Golgasht Street
    Street address - Persian: خیابان گلگشت، خیابان عطار نیشابوری، دانشکده تغذیه
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3335 7580
    Mobile: +98 914 116 3184
    Fax:
    Email: helda.nutrition@gmail.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Helda Tutunchi
    Full name of responsible person - Persian: هلدا توتونچی
    Position - English: Assistant Professor of Nutritional Sciences
    Position - Persian: استادیار 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: Attar - e - Neyshabouri
    Street address - Persian: عطار نیشابوری
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 914 116 3184
    Mobile: +98 914 116 3184
    Fax:
    Email: helda.nutrition@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Helda Tutunchi
    Full name of responsible person - Persian: هلدا توتونچی
    Position - English: Assistant Professor of Nutritional Sciences
    Position - Persian: استادیار 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 Faculty, Attar Neyshabouri Avenue, Golgasht Street
    Street address - Persian: خیابان گلگشت، خیابان عطار نیشابوری، دانشکده تغذیه
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3335 7580
    Mobile: +98 914 116 3184
    Fax:
    Email: helda.nutrition@gmail.com
    Web page address:

Protocol summary

Study aim
The effect of boron citrate supplementation on nutritional status, cardiometabolic factors and indices of TNF-α, IL-10, IL-6 and CRP in obese subjects.
Design
randomized, double-blinded, controlled trial, containing supplement and intervention groups, with parallel groups, sample size of 60 participants (30 in each group), RAS (Random Allocation Software) used for randomization.
Settings and conduct
This study will be conducted on 60 obese patients at Tabriz University of Medical Sciences Faculty of Nutrition. Patients will be divided into 2 equal groups of supplement and placebo and will receive boron citrate and placebo (maltodextrin) respectively for 12 weeks. In order to blind all researchers and participants, a person not involved in the experiment randomly assigns a list to the participants in each group and labels all identical containers (in appearance and color) according to their number. Therefore, participants will be unaware of the type of intervention they are receiving. The random sequence will also be unpredictable.
Participants/Inclusion and exclusion criteria
Inclusion criteria: obese people/Exclusion criteria: pregnancy and breastfeeding, smoking, following special diets 3 months before the study, taking chemical or herbal weight loss drugs, taking hepatotoxic drugs, taking blood pressure control drugs and blood lipid-lowering drugs
Intervention groups
Participants will be divided into two groups of 30 people: intervention group (1 capsule containing 10 mg boron citrate per day before lunch) and placebo group (1 capsule per day of maltodextrin before lunch) and will use the supplement or placebo for 12 weeks.
Main outcome variables
glucose-insulin-HbA1c-insulin resistance with HOMA-IR score, lipid pattern, systolic and diastolic blood pressure) CRP, TNF-α, IL-10, and IL-6)

General information

Reason for update
Delay in obtaining the necessary financial credit to start the project
Acronym
IRCT registration information
IRCT registration number: IRCT20220806055624N1
Registration date: 2022-08-31, 1401/06/09
Registration timing: prospective

Last update: 2023-04-06, 1402/01/17
Update count: 3
Registration date
2022-08-31, 1401/06/09
Registrant information
Name
Helda Tutunchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7580
Email address
helda.nutrition@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of boron citrate supplementation on nutritional status, cardiometabolic factors, and inflammatory indices of TNF-α, IL-10, IL-6, and CRP in obese people
Public title
Boron citrate in obesity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
BMI: 30–40 (kg/m²) Willingness to participate in the study
Exclusion criteria:
Athlete, pregnancy, lactation and menopause in women Under infertility treatment, taking birth control pills and estrogen Smoking and history of alcohol consumption Following a special diet three months before the study Use of chemical or herbal drugs for weight loss and use of hepatotoxic drugs such as phenytoin, amoxifene, lithium, blood pressure control drugs and blood lipid lowering drugs (statins), drugs that increase insulin sensitivity. Taking antibiotics or supplements affecting liver enzyme levels Weight loss surgery in the last year or strict weight loss diets in the last three months Using corticosteroid and non-steroidal anti-inflammatory drugs and any supplements for 3 months before the study or during the study Cardiovascular diseases, liver, kidney, intestinal, thyroid and parathyroid dysfunction, biliary disease, known autoimmune diseases, polycystic ovary syndrome, cancers and malabsorption diseases such as sprue and Crohn's Having symptoms of infectious or inflammatory disease or recent surgery Performed or candidate for liver transplant
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To stratify individuals into distinct strata and blocks, stratified block randomization will be implemented based on age (18-40 vs. 40-60 years) and gender (male vs. female). For each individual placed in a given stratum, a matched individual is considered based on these variables in the same stratum. As a result, two participants with similar characteristics (for age and gender) are placed in the same stratum. Finally, each stratum will be randomly allocated to the intervention or control groups using Random Allocation Software (RAS). Participants and researchers will be blinded to the randomization and allocation until the end of the study. The randomization list will be provided by the pharmacist of the research center at the end of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and researchers will be blind to the type of supplements (boron citrate or placebo). The person responsible for preparing the supplement packages (a person completely unrelated to the study) will be asked to assign a three-digit code to each of the two received supplements (boron citrate or placebo) and keep the codes for himself until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The specialized committee of ethics in biomedical research
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Approval date
2022-07-11, 1401/04/20
Ethics committee reference number
IR.TBZMED.REC.1401.350

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
weight
Timepoint
Beginning and end of the trial
Method of measurement
weight scale

2

Description
body mass scale
Timepoint
Beginning and end of the trial
Method of measurement
Calculation based on formula

3

Description
waist circumstance
Timepoint
Beginning and end of the trial
Method of measurement
tape measure

4

Description
waist to hio ratio
Timepoint
Beginning and end of the trial
Method of measurement
Calculation based on formula

5

Description
waist circumstance to height ratio
Timepoint
Beginning and end of the trial
Method of measurement
Calculation based on formula

6

Description
CRP (c-reactive protein)
Timepoint
Beginning and end of the trial
Method of measurement
ELISA

7

Description
TNF-α (Tumor necrosis factor-α)
Timepoint
Beginning and end of the trial
Method of measurement
ELISA

8

Description
IL-10
Timepoint
Beginning and end of the trial
Method of measurement
ELISA

9

Description
IL-6
Timepoint
Beginning and end of the trial
Method of measurement
ELISA

10

Description
total body fat mass (FM)
Timepoint
Beginning and end of the trial
Method of measurement
bioelectrical impedance analysis

11

Description
total body fat‐free mass (FFM)
Timepoint
Beginning and end of the trial
Method of measurement
bioelectrical impedance analysis

12

Description
hip circumference
Timepoint
Beginning and end of the trial
Method of measurement
tape measure

Secondary outcomes

1

Description
energy consumption
Timepoint
Beginning and end of the trial
Method of measurement
Questionnaire

2

Description
macronutrient consumption
Timepoint
Beginning and end of the trial
Method of measurement
Questionnaire

3

Description
blood glucose
Timepoint
Beginning and end of the trial
Method of measurement
Use of an enzymatic kit method

4

Description
Fasting insulin levels
Timepoint
Beginning and end of the trial
Method of measurement
ELISA

5

Description
Insulin resistance with HOMA-IR score
Timepoint
Beginning and end of the trial
Method of measurement
Calculation based on formula

6

Description
LDL-c
Timepoint
Beginning and end of the trial
Method of measurement
Calculation based on the Friedewald formula

7

Description
HDL-c
Timepoint
Beginning and end of the trial
Method of measurement
Use of an enzymatic kit method

8

Description
total cholesterol
Timepoint
Beginning and end of the trial
Method of measurement
Use of an enzymatic kit method

9

Description
Triglyceride
Timepoint
Beginning and end of the trial
Method of measurement
Use of an enzymatic kit method

10

Description
systolic blood pressure
Timepoint
Beginning and end of the trial
Method of measurement
mercury manometer

11

Description
diastolic blood pressure
Timepoint
Beginning and end of the trial
Method of measurement
mercury manometer

12

Description
QUICKI
Timepoint
Beginning and end of the trial
Method of measurement
Calculation based on formula

Intervention groups

1

Description
Intervention group: Patients in this group will receive dietary recommendations and boron citrate capsules including 10 mg boron for 12 weeks. Boron citrate capsules is made in Iran, and once a day before lunch will be consumed.
Category
Prevention

2

Description
Control group: Patients in this group will receive dietary recommendations with placebo for 12 weeks. The placebo is starch (containing 10 mg of maltodextrin) and once a day before lunch will be consumed.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Nutrition Research Center of Tabriz University of Medical Sciences
Full name of responsible person
Helda Tutunchi
Street address
Nutrition faculty, Tabriz University of Medical Science, Golgasht Avenue, Attar Neyshabouri Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 914 116 3184
Email
helda.nutrition@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Tabriz University of Medical Sciences, Attar Neishabouri Street, Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Helda Tutunchi
Position
Assistant Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
helda.nutrition@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Helda Tutunchi
Position
Assistant Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
helda.nutrition@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Helda Tutunchi
Position
Assistant Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
helda.nutrition@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
access starting 12 months after publication
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.
From where data/document is obtainable
The researchers (student and her supervisor)
What processes are involved for a request to access data/document
Request a document via email
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