Production of Functional Oral Powder Enriched with Curcumin, Probiotics, and their Combination and Determination of their Effect on Appetite, Leptin, and Ghrelin Hormones and Some Anthropometric Indices in Patients with Metabolic Syndrome with Overweight or Obesity: a Randomized Double-Blind Controlled Clinical Trial
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Protocol summary
The aim of this study is to evaluate the effect of oral powder enriched with curcumin and probiotics on appetite, leptin and ghrelin hormones, and some anthropometric and lipid indices of patients with metabolic syndrome.
The aim of this study is to evaluate the effect of oral powder enriched with curcumin and probiotics on appetite, leptin and ghrelin hormones, and some anthropometric indices of patients with metabolic syndrome.
The aim of this study is to evaluate the effect of oral powder enriched with curcumin and probiotics on appetite, leptin and ghrelin hormones, and some anthropometric and lipid indices of patients with metabolic syndrome.
هدف از این مطالعه بررسی اثر پودر خوراکی غنی شده با کورکومین و پروبیوتیک بر اشتها، هورمون های لپتین و گرلین و برخی شاخص های تن سنجی و چربی خون بیماران مبتلا به سندرم متابولیک می باشد.
هدف از این مطالعه بررسی اثر پودر خوراکی غنی شده با کورکومین و پروبیوتیک بر اشتها، هورمون های لپتین و گرلین و برخی شاخص های تن سنجی بیماران مبتلا به سندرم متابولیک می باشد.
هدف از این مطالعه بررسی اثر پودر خوراکی غنی شده با کورکومین و پروبیوتیک بر اشتها، هورمون های لپتین و گرلین و برخی شاخص های تن سنجی و چربی خون بیماران مبتلا به سندرم متابولیک می باشد.
Patients with metabolic syndrome are referred to Imam Reza Clinic and are randomly divided into 4 study groups. The informed consent form, demographic information, physical activity (IPAQ), 3-day food record, and visual appetite scale (VAS) questionnaires are completed for all individuals before and after the study. Anthropometric measurements, evaluation of leptin and ghrelin hormones, and measurement of the lipid profile are performed before and after the study. The appearance of the intervention powders is quite similar. The researcher and all participants will be blinded to the intervention and random allocation.
Patients with metabolic syndrome are referred to Imam Reza Clinic and are randomly divided into 4 study groups. The informed consent form, demographic information, physical activity (IPAQ), 3-day food record, and visual appetite scale (VAS) questionnaires are completed for all individuals before and after the study. Anthropometric measurements and evaluation of leptin and ghrelin hormones are performed before and after the study. The appearance of the intervention powders is quite similar. The researcher and all participants will be blinded to the intervention and random allocation.
Patients with metabolic syndrome are referred to Imam Reza Clinic and are randomly divided into 4 study groups. The informed consent form, demographic information, physical activity (IPAQ), 3-day food record, and visual appetite scale (VAS) questionnaires are completed for all individuals before and after the study. Anthropometric measurements, and evaluation of leptin and ghrelin hormones, and measurement of the lipid profile are performed before and after the study. The appearance of the intervention powders is quite similar. The researcher and all participants will be blinded to the intervention and random allocation.
بیماران مبتلا به سندرم متابولیک به کلینیک امام رضا ارجاع داده می شوند و به طور تصادفی در 4 گروه مطالعه قرار می گیرند. فرم رضایت آگاهانه، پرسشنامه های اطلاعات دموگرافیک، فعالیت فیزیکی IPAQ، ثبت غذایی ۳ روزه و مقیاس بصری اشتها (VAS) جهت همه افراد قبل و بعد از مطالعه تکمیل می‌گردد. ارزیابی‌های تن‌سنجی ، ارزیابی هورمون‌های لپتین و گرلین و اندازه‌گیری پروفایل لیپیدی قبل و بعد از مطالعه انجام می‌گیرد.
ظاهر پودرهای مداخله کاملا شبیه به هم هستند. پژوهشگر و همه شرکت کنندگان نسبت به مداخله و تخصیص تصادفی کورسازی خواهند شد.
بیماران مبتلا به سندرم متابولیک به کلینیک امام رضا ارجاع داده می شوند و به طور تصادفی در 4 گروه مطالعه قرار می گیرند. فرم رضایت آگاهانه، پرسشنامه های اطلاعات دموگرافیک، فعالیت فیزیکی IPAQ، ثبت غذایی ۳ روزه و مقیاس بصری اشتها (VAS) جهت همه افراد قبل و بعد از مطالعه تکمیل می‌گردد. ارزیابی‌های تن‌سنجی ، ارزیابی هورمون‌های لپتین و گرلین و قبل و بعد از مطالعه انجام می‌گیرد.
ظاهر پودرهای مداخله کاملا شبیه به هم هستند. پژوهشگر و همه شرکت کنندگان نسبت به مداخله و تخصیص تصادفی کورسازی خواهند شد.
بیماران مبتلا به سندرم متابولیک به کلینیک امام رضا ارجاع داده می شوند و به طور تصادفی در 4 گروه مطالعه قرار می گیرند. فرم رضایت آگاهانه، پرسشنامه های اطلاعات دموگرافیک، فعالیت فیزیکی IPAQ، ثبت غذایی ۳ روزه و مقیاس بصری اشتها (VAS) جهت همه افراد قبل و بعد از مطالعه تکمیل می‌گردد. ارزیابی‌های تن‌سنجی ، ارزیابی هورمون‌های لپتین و گرلین و اندازه‌گیری پروفایل لیپیدی قبل و بعد از مطالعه انجام می‌گیرد. ظاهر پودرهای مداخله کاملا شبیه به هم هستند. پژوهشگر و همه شرکت کنندگان نسبت به مداخله و تخصیص تصادفی کورسازی خواهند شد.
Inclusion criteria: people 30 to 65 years old with metabolic syndrome (MS)
Non-inclusion criteria: pregnancy; lactation; Kidney, liver, systemic, metabolic, endocrine, and cardiovascular diseases except diabetes, dyslipidemia, and hypertension; having any components of the MS such as diabetes, hypertension, or dyslipidemia that require drug treatment; take any supplements or medications during 3 previous months.
Inclusion criteria: people 30 to 65 years old with metabolic syndrome (MS)
Non-inclusion criteria: pregnancy; lactation; Kidney, liver, systemic, metabolic, endocrine, and cardiovascular diseases except diabetes, dyslipidemia, and hypertension; take any supplements or antibiotics during 3 previous months.
Inclusion criteria: people 30 to 65 years old with metabolic syndrome (MS) Non-inclusion criteria: pregnancy; lactation; Kidney, liver, systemic, metabolic, endocrine, and cardiovascular diseases except diabetes, dyslipidemia, and hypertension; having any components of the MS such as diabetes, hypertension, or dyslipidemia that require drug treatment; take any supplements or medicationsantibiotics during 3 previous months.
شرایط ورود: افراد 30 تا 65 سال مبتلا به سندرم متابولیک
شرایط عدم ورود: بارداری، شیردهی، ابتلا به بیماری‌های کلیوی، کبدی، سیستمیک، متابولیک، غدد و قلبی-عروقی (به‌جز دیابت، دیس لیپیدمی و فشارخون)، ابتلا به اجزای سندروم متابولیک (دیابت، فشار خون، و یا دیس لیپیدمی) که نیاز به درمان دارویی داشته باشند و مصرف هرگونه مکمل یا دارو به مدت ۳ ماه قبل از مطالعه
شرایط ورود: افراد 30 تا 65 سال مبتلا به سندرم متابولیک
شرایط عدم ورود: بارداری، شیردهی، ابتلا به بیماری‌های کلیوی، کبدی، سیستمیک، متابولیک، غدد و قلبی-عروقی (به‌جز دیابت، دیس لیپیدمی و فشارخون) و مصرف هرگونه مکمل یا آنتی بیوتیک به مدت ۳ ماه قبل از مطالعه
شرایط ورود: افراد 30 تا 65 سال مبتلا به سندرم متابولیک شرایط عدم ورود: بارداری، شیردهی، ابتلا به بیماری‌های کلیوی، کبدی، سیستمیک، متابولیک، غدد و قلبی-عروقی (به‌جز دیابت، دیس لیپیدمی و فشارخون)، ابتلا به اجزای سندروم متابولیک (دیابت، فشار خون، و یا دیس لیپیدمی) که نیاز به درمان دارویی داشته باشند و مصرف هرگونه مکمل یا داروآنتی بیوتیک به مدت ۳ ماه قبل از مطالعه
Primary outcomes: leptin hormone, ghrelin hormone, and appetite status
Secondary outcomes: lipid profile and anthropometric factors
Primary outcomes: leptin hormone, ghrelin hormone, and appetite status
Secondary outcomes: anthropometric factors
Primary outcomes: leptin hormone, ghrelin hormone, and appetite status Secondary outcomes: lipid profile and anthropometric factors
پیامدهای اولیه: هورمون لپتین و گرلین، وضعیت اشتها
پیامدهای ثانویه: پروفایل لیپیدی و فاکتورهای تن‌سنجی
پیامدهای اولیه: هورمون لپتین و گرلین، وضعیت اشتها پیامدهای ثانویه: پروفایل لیپیدی و فاکتورهای تن‌سنجی
General information
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Due to the lack of sufficient budgets, it was not possible to measure blood lipid indices after the study, and these indices were removed from the title. Also, due to the fact that most patients with metabolic syndrome were taking medication, we had difficulty finding patients and had to change the inclusion criteria. Finally, we included the patients who were receiving medicine in the study.
Due to the lack of sufficient budgets, it was not possible to measure blood lipid indices after the study, and these indices were removed from the title. Also, due to the fact that most patients with metabolic syndrome were taking medication, we had difficulty finding patients and had to change the inclusion criteria. Finally, we included the patients who were receiving medicine in the study.
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به دلیل نبود بودجه کافی، امکان اندازه گیری شاخصهای چربی خون بعد از مطالعه نبود و این شاخصها از عنوان حذف شدند. همچنین به دلیل اینکه اکثر بیماران مبتلا به سندرم متابولیک دارو مصرف می کردند، در یافتن بیماران با مشکل مواجه شدیم و مجبور به تغییر معیارهای ورود شدیم. در نهایت بیمارانی که دارو دریافت میکردند را وارد مطالعه کردیم.
به دلیل نبود بودجه کافی، امکان اندازه گیری شاخصهای چربی خون بعد از مطالعه نبود و این شاخصها از عنوان حذف شدند. همچنین به دلیل اینکه اکثر بیماران مبتلا به سندرم متابولیک دارو مصرف می کردند، در یافتن بیماران با مشکل مواجه شدیم و مجبور به تغییر معیارهای ورود شدیم. در نهایت بیمارانی که دارو دریافت میکردند را وارد مطالعه کردیم.
Production of Functional Oral Powder Enriched with Curcumin, Probiotics, and their Combination and Determination of their Effect on Appetite, Leptin, and Ghrelin Hormones and Some Anthropometric and Lipid Profiles in Patients with Metabolic Syndrome with Overweight or Obesity: a Randomized Double-Blind Controlled Clinical Trial
Production of Functional Oral Powder Enriched with Curcumin, Probiotics, and their Combination and Determination of their Effect on Appetite, Leptin, and Ghrelin Hormones and Some Anthropometric Indices in Patients with Metabolic Syndrome with Overweight or Obesity: a Randomized Double-Blind Controlled Clinical Trial
Production of Functional Oral Powder Enriched with Curcumin, Probiotics, and their Combination and Determination of their Effect on Appetite, Leptin, and Ghrelin Hormones and Some Anthropometric and Lipid ProfilesIndices in Patients with Metabolic Syndrome with Overweight or Obesity: a Randomized Double-Blind Controlled Clinical Trial
تولید پودر خوراکی فراسودمند غنی‌شده با کورکومین، پروبیوتیک و توامان و تعیین اثر آن‌ها بر میزان اشتها، هورمون‌های لپتین و گرلین و برخی شاخصهای تن‌سنجی و شاخص های چربی خون بیماران مبتلابه سندروم متابولیک با اضافه‌وزن یا چاقی: یک مطالعه کارآزمایی بالینی تصادفی دوسو کور کنترل شده
تولید پودر خوراکی فراسودمند غنی‌شده با کورکومین، پروبیوتیک و توامان و تعیین اثر آن‌ها بر میزان اشتها، هورمون‌های لپتین و گرلین و برخی شاخصهای تن‌سنجی بیماران مبتلابه سندروم متابولیک با اضافه‌وزن یا چاقی: یک مطالعه کارآزمایی بالینی تصادفی دوسو کور کنترل شده
تولید پودر خوراکی فراسودمند غنی‌شده با کورکومین، پروبیوتیک و توامان و تعیین اثر آن‌ها بر میزان اشتها، هورمون‌های لپتین و گرلین و برخی شاخصهای تن‌سنجی و شاخص های چربی خون بیماران مبتلابه سندروم متابولیک با اضافه‌وزن یا چاقی: یک مطالعه کارآزمایی بالینی تصادفی دوسو کور کنترل شده
Pregnancy
Lactation
Metabolic, endocrine, and cardiovascular diseases except diabetes, dyslipidemia, and hypertension
Having any components of the metabolic syndrome such as diabetes, hypertension, or dyslipidemia that require drug treatment
Take any supplements or medications during the previous 3 months
Pregnancy
Lactation
Suffering from kidney, liver, and systemic diseases at the beginning of the study
Metabolic, endocrine, and cardiovascular diseases except diabetes, dyslipidemia, and hypertension
Take any supplements or antibiotics during the previous 3 months
Pregnancy Lactation Suffering from kidney, liver, and systemic diseases at the beginning of the study Metabolic, endocrine, and cardiovascular diseases except diabetes, dyslipidemia, and hypertension Having any components of the metabolic syndrome such as diabetes, hypertension, or dyslipidemia that require drug treatment Take any supplements or medicationsantibiotics during the previous 3 months
بارداری
شیردهی
ابتلا به بیماری‌های کلیوی، کبدی و سیستمیک در ابتدای مطالعه
ابتلا به بیماری‌های متابولیک، غدد و قلبی-عروقی (به‌جز دیابت، دیس لیپیدمی و فشارخون)
ابتلا به اجزای سندروم متابولیک (دیابت، فشار خون، و یا دیس لیپیدمی) که نیاز به درمان دارویی داشته باشند
مصرف هرگونه مکمل یا دارو به مدت ۳ ماه قبل از مطالعه
بارداری
شیردهی
ابتلا به بیماری‌های کلیوی، کبدی و سیستمیک در ابتدای مطالعه
ابتلا به بیماری‌های متابولیک، غدد و قلبی-عروقی (به‌جز دیابت، دیس لیپیدمی و فشارخون)
مصرف هرگونه مکمل یا آنتی بیوتیک به مدت ۳ ماه قبل از مطالعه
بارداری شیردهی ابتلا به بیماری‌های کلیوی، کبدی و سیستمیک در ابتدای مطالعه ابتلا به بیماری‌های متابولیک، غدد و قلبی-عروقی (به‌جز دیابت، دیس لیپیدمی و فشارخون) ابتلا به اجزای سندروم متابولیک (دیابت، فشار خون، و یا دیس لیپیدمی) که نیاز به درمان دارویی داشته باشند مصرف هرگونه مکمل یا داروآنتی بیوتیک به مدت ۳ ماه قبل از مطالعه
Secondary outcomes
#1
Lipid profile
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Lipid profile
پروفایل لیپیدی
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پروفایل لیپیدی
Before the intervention and 8 weeks after the start of the intervention
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Before the intervention and 8 weeks after the start of the intervention
قبل از مداخله و 8 هفته بعد از شروع مداخله
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قبل از مداخله و 8 هفته بعد از شروع مداخله
Kit
empty
Kit
کیت
empty
کیت
Recruitment centers
#1
Name of recruitment center - English: Emam Reza Clinic
Name of recruitment center - Persian: کلینیک امام رضا
Full name of responsible person - English: Mohammad Hassan Eftekhari
Full name of responsible person - Persian: محمد حسن افتخاری
Street address - English: Namazi Square, Zand Street
Street address - Persian: خیابان زند، میدان نمازی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134814734
Phone: +98 71 3212 7000
Fax: +98 71 3647 4673
Email: h_eftekhari@yahoo.com
Web page address:
Name of recruitment center - English: Emam Reza clinic
Name of recruitment center - Persian: کلینیک امام رضا
Full name of responsible person - English: Mohammad Hassan Eftekhari
Full name of responsible person - Persian: محمد حسن افتخاری
Street address - English: Namazi Square, Zand Ave
Street address - Persian: خیابان زند، میدان نمازی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134814734
Phone: +98 71 3212 7000
Fax: +98 71 3647 4673
Email: h_eftekhari@yahoo.com
Web page address:
Name of recruitment center - English: Emam Reza Clinicclinic Name of recruitment center - Persian: کلینیک امام رضا Full name of responsible person - English: Mohammad Hassan Eftekhari Full name of responsible person - Persian: محمد حسن افتخاری Street address - English: Namazi Square, Zand StreetAve Street address - Persian: خیابان زند، میدان نمازی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7134814734 Phone: +98 71 3212 7000 Fax: +98 71 3647 4673 Email: h_eftekhari@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahtab Memarpour
Full name of responsible person - Persian: مهتاب معمارپور
Street address - English: Central building of Shiraz University of Medical Sciences,Zand Street
Street address - Persian: خیابان زند، ساختمان مرکزی دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134814336
Phone: +98 71 3235 7282
Fax: +98 71 3212 2430
Email: memarpour@sums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahtab Memarpour
Full name of responsible person - Persian: مهتاب معمارپور
Street address - English: Shiraz University of Medical Sciences, Zand Ave
Street address - Persian: خیابان زند، دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134814336
Phone: +98 71 3235 7282
Fax: +98 71 3212 2430
Email: memarpour@sums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mahtab Memarpour Full name of responsible person - Persian: مهتاب معمارپور Street address - English: Central building of Shiraz University of Medical Sciences,Zand StreetSciences, Zand Ave Street address - Persian: خیابان زند، ساختمان مرکزی دانشگاه علوم پزشکی شیراز City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7134814336 Phone: +98 71 3235 7282 Fax: +98 71 3212 2430 Email: memarpour@sums.ac.ir Web page address:
Protocol summary
Study aim
The aim of this study is to evaluate the effect of oral powder enriched with curcumin and probiotics on appetite, leptin and ghrelin hormones, and some anthropometric indices of patients with metabolic syndrome.
Design
A parallel randomized double-blind controlled clinical trial of 124 patients. Block randomization with a fixed block size of 4 will be done.
Settings and conduct
Patients with metabolic syndrome are referred to Imam Reza Clinic and are randomly divided into 4 study groups. The informed consent form, demographic information, physical activity (IPAQ), 3-day food record, and visual appetite scale (VAS) questionnaires are completed for all individuals before and after the study. Anthropometric measurements and evaluation of leptin and ghrelin hormones are performed before and after the study. The appearance of the intervention powders is quite similar. The researcher and all participants will be blinded to the intervention and random allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: people 30 to 65 years old with metabolic syndrome (MS)
Non-inclusion criteria: pregnancy; lactation; Kidney, liver, systemic, metabolic, endocrine, and cardiovascular diseases except diabetes, dyslipidemia, and hypertension; take any supplements or antibiotics during 3 previous months.
Intervention groups
Group 1 receives the functional curcumin-enriched oral powder.
Group 2 receives the functional probiotics-enriched oral powder.
Group 3 receives the functional oral powder enriched with curcumin and probiotics.
Group 4 receives the placebo oral powder.
Main outcome variables
Primary outcomes: leptin hormone, ghrelin hormone, and appetite status
Secondary outcomes: anthropometric factors
General information
Reason for update
Due to the lack of sufficient budgets, it was not possible to measure blood lipid indices after the study, and these indices were removed from the title. Also, due to the fact that most patients with metabolic syndrome were taking medication, we had difficulty finding patients and had to change the inclusion criteria. Finally, we included the patients who were receiving medicine in the study.
Acronym
IRCT registration information
IRCT registration number:IRCT20220315054290N1
Registration date:2022-04-03, 1401/01/14
Registration timing:prospective
Last update:2023-08-08, 1402/05/17
Update count:1
Registration date
2022-04-03, 1401/01/14
Registrant information
Name
Farzaneh Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 8099
Email address
mohamadyfa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Production of Functional Oral Powder Enriched with Curcumin, Probiotics, and their Combination and Determination of their Effect on Appetite, Leptin, and Ghrelin Hormones and Some Anthropometric Indices in Patients with Metabolic Syndrome with Overweight or Obesity: a Randomized Double-Blind Controlled Clinical Trial
Public title
The Effect of Oral Powder Enriched with Curcumin and Probiotics on Patients with Metabolic Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 30-60 years old
Metabolic syndrome patients are diagnosed based on the Adult Treatment Panel III (ATP III) criterion
Consent to participate in the study
Exclusion criteria:
Pregnancy
Lactation
Suffering from kidney, liver, and systemic diseases at the beginning of the study
Metabolic, endocrine, and cardiovascular diseases except diabetes, dyslipidemia, and hypertension
Take any supplements or antibiotics during the previous 3 months
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Before beginning the study, an outsider who is familiar with the randomization method prepares 4 blocks of random blocks, then randomly identifies the sequences and groups them in a closed envelope, named A, B, C, and D. After the individuals enter the study, the sealed envelopes containing the assigned group of participants will be opened for each participant based on the sequence determined by the person outside the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The appearance of the beverage powders and sachets in which they are packaged are quite similar. The sachets will be named with the Latin letters A, B, C, and D. In the clinical phase of the study, the random allocation sequence is done with the same letters. Therefore, the researcher and all participants will be blinded to the intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2022-01-30, 1400/11/10
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1400.092
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
Primary outcomes
1
Description
Leptin hormone
Timepoint
Before the study and 8 weeks after the start of the study
Method of measurement
Leptin kit (ELISA)
2
Description
Ghrelin hormone
Timepoint
Before the study and 8 weeks after the start of the study
Method of measurement
Ghrelin kit (ELISA)
3
Description
Appetite
Timepoint
Before the study and 8 weeks after the start of the study
Method of measurement
Visual Analog Scale (VAS) questionnaire
Secondary outcomes
1
Description
Weight
Timepoint
Before the intervention and 8 weeks after the start of the intervention
Method of measurement
Scale
2
Description
Waist circumference
Timepoint
Before the intervention and 8 weeks after the start of the intervention
Method of measurement
Inelastic tape
3
Description
Body fat percentage
Timepoint
Before the intervention and 8 weeks after the start of the intervention
Method of measurement
Body analyzer device
Intervention groups
1
Description
The first intervention group will receive a daily oral powder enriched with 1 gram of curcumin for 8 weeks. Curcumin powder will be supplied by Karen Company.
Category
Treatment - Other
2
Description
The second intervention group will receive 10 to 9 CFU-enriched oral powders (Lactobacillus rhamnosus and Lactobacillus acidophilus) daily for 8 weeks. Probiotics will be provided by Parsi Lact Company.
Category
Treatment - Other
3
Description
The third intervention group will receive daily oral powder enriched with 1 gram of curcumin and 10 to 9 CFU probiotics for 8 weeks. Curcumin will be supplied by Karen Company and probiotics will be supplied by Parsi Lact Company.
Category
Treatment - Other
4
Description
The control group will receive placebo oral powder daily for 8 weeks. Placebo powder will be supplied by Parsi Lact Company.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza clinic
Full name of responsible person
Mohammad Hassan Eftekhari
Street address
Namazi Square, Zand Ave
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Fax
+98 71 3647 4673
Email
h_eftekhari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Street address
Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
memarpour@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Mohammadi
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutrition & Food Sciences, Razi Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3725 8099
Email
mohamadyfa@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hassan Eftekhari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nurition & Food Sciences, Razi Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3725 8099
Email
h_eftekhari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ali Mohsenpour
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutrition & Food Sciences, Razi Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3725 8099
Email
mohammadali.mohsenpour@gmail.com
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