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Evaluation of the effectiveness of propolis dietary supplement on metabolic syndrome and its components in patients with metabolic syndrome: a randomized, controlled, double-blinded clinical trial

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History
# Registration date Revision Id
2 2022-08-09, 1401/05/18 235999
1 2020-12-23, 1399/10/03 164232
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  • Protocol summary

    A randomized, double-blind, clinical trial of phase 3 with a parallel groups design of 60 patients. Table of random numbers is used for randomization.
    A randomized, double-blind, clinical trial with a parallel groups design of 60 patients.
    یک کارآزمایی بالینی تصادفی سازی شده دوسوکور دارای گروه کنترل باگروه های موازی، فاز 3 برروی 60 بیمار می باشد. برای تصادفی از جدول اعداد تصادفی استفاده می شود.
    یک کارآزمایی بالینی تصادفی سازی شده دوسوکور دارای گروه کنترل باگروه های موازی، برروی 60 بیمار می باشد.
    inclusion criteria: patients with metabolic syndrome according to NCEP-ATP III, adults 20-60 years old, willingness to participate, ability to read and write; criteria for not entering: pregnancy or lactation, having certain diseases, tobacco and alcohol consumption, adherence a weight-loss diet or physical activity program, insulin injection, drugs that affect blood glucose, lipid, blood pressure, and body weight
    inclusion criteria: patients with metabolic syndrome according to NCEP-ATP III, adults 20-60 years old, willingness to participate, ability to read and write; criteria for not entering: pregnancy or lactation, having certain diseases, tobacco and alcohol consumption, adherence to a weight-loss diet or physical activity program, insulin injection, Change in the type and dosage of medication from 3 months before entering the study
    معیار ورود: افراد مبتلا به سندرم متابولیک باتوجه به معیارهای (NCEP-ATP III)، بالغین 20 تا60 ساله، تمایل به شرکت، توانایی خواندن و نوشتن; معیار عدم ورود: بارداری و شیردهی، ابتلا به بیماری های خاص، مصرف دخانیات و الکل، پیروی از برنامه رژیم غذایی کاهش وزن یا ورزشی، مصرف انسولین، داروهای موثر بر قند خون، چربی، فشارخون و و وزن بدن
    معیار ورود: افراد مبتلا به سندرم متابولیک باتوجه به معیارهای (NCEP-ATP III)، بالغین 20 تا60 ساله، تمایل به شرکت، توانایی خواندن و نوشتن; معیار عدم ورود: بارداری و شیردهی، ابتلا به بیماری های خاص، مصرف دخانیات و الکل، پیروی از برنامه رژیم غذایی کاهش وزن یا ورزشی، مصرف انسولین، تغییر در دوز و نوع دارو از 3 ماه قبل
    Fasting blood sugar; Triglyceride; Total cholesterol; High-density lipoprotein; Low-density lipoprotein; Insulin; HOMA-IR index; Weight; Height; Waist; BMI; Blood pressure; C- reactive protein
    Fasting blood sugar; Triglyceride; Total cholesterol; High-density lipoprotein; Low-density lipoprotein; Insulin; HOMA-IR index; Weight; Waist; BMI; Blood pressure; C- reactive protein, Quality of life, Mood status
    قند خون ناشتا، تریگلیسرید، توتال کلسترول، لیپوپروتئین با چگالی زیاد ،لیپوپروتئین با چگالی کم، شاخص مقاومت به انسولین، انسولین، وزن، قد، دور کمر، نمایه توده بدنی، فشارخون، پروتئین واکنشگر C
    قند خون ناشتا، تریگلیسرید، توتال کلسترول، لیپوپروتئین با چگالی زیاد ،لیپوپروتئین با چگالی کم، شاخص مقاومت به انسولین، انسولین، وزن، دور کمر، نمایه توده بدنی، فشارخون، پروتئین واکنشگر C، کیفیت زندگی، وضعیت خلق و خو

  • General information

    1
    2021-02-19, 1399/12/01
    2021-09-23, 1400/07/01
    empty
    Change in some exclusion criteria
    empty
    تغییر در برخی از معیارهای عدم ورود
    Pregnancy and lactation
    Having the following disease: Malignancies or cancer, type I diabetes, thyroid disorders, nephrotic syndrome, kidney and lung disease, liver and biliary disease, cardiovascular, and HIV
    Sensitivity to bee products
    Adherence a weight loss diet or physical activity program
    Tobacco and alcohol consumption
    Insulin injection
    Use of drugs that affect blood glucose, lipid, blood pressure, and body weight
    Pregnancy and lactation
    Having the following disease: Malignancies or cancer, type I diabetes, nephrotic syndrome, kidney and lung disease, biliary disease, and HIV
    Sensitivity to bee products
    Adherence a weight loss diet or physical activity program
    Tobacco and alcohol consumption
    Insulin injection
    Change in the type and dosage of medication from 3 months before entering the study
    بارداری و شیردهی
    ابتلا به بدخیمی ها یا سرطان، دیابت تیپ Ι، اختلالات غده تیروئید، سندرم نفروتیک، بیماری کلیوی و ریوی ، بیماری کبدی و صفراوی، بیماری قلبی و عروقی و HIV
    حساسیت به محصولات زنبور عسل
    پیروی از برنامه رژیم غذایی کاهش وزن یا ورزشی
    استعمال دخانیات، الکل
    مصرف انسولین
    استفاده از دارو های موثر بر قند خون، چربی خون و فشارخون و وزن بدن
    بارداری و شیردهی
    ابتلا به بدخیمی ها یا سرطان، دیابت تیپ Ι، سندرم نفروتیک، بیماری کلیوی و ریوی ، صفراوی، و HIV
    حساسیت به محصولات زنبور عسل
    پیروی از برنامه رژیم غذایی کاهش وزن یا ورزشی
    استعمال دخانیات، الکل
    مصرف انسولین
    تغییر در نوع و دوز دارو از 3 ماه قبل از ورود به مطالعه

  • Secondary outcomes

    #1
    Colorimetric analysis method and by autoanalyzer
    Immunoturbidimetric
    روش کلریمتریک و بوسیله دستگاه اتوآنالایزر
    Immunoturbidimetric
    #2
    empty
    Quality of Life
    empty
    کیفیت زندگی
    empty
    At the beginning of the study and 12 weeks after supplementation
    empty
    ابتدای مطالعه و 12 هفته بعد از مکمل یاری
    empty
    A validated questionnaire- 36-Item Short Form Health Survey (SF-36)
    empty
    پرسشنامه ولید شده 36item Short Form Health Survey (SF-36)
    #3
    empty
    Mood status (Stress, depression, anxiety)
    empty
    وضعیت خلق و خو (استرس، افسردگی، اضطراب)
    empty
    At the beginning of the study and 12 weeks after supplementation
    empty
    ابتدای مطالعه و 12 هفته بعد از مکمل یاری
    empty
    A validated questionnaire DASS-21
    empty
    پرسشنامه ولید شده DASS-21

  • Recruitment centers

    #1
    Name of recruitment center - English: Dr. Mansour Siavash's office, Endocrine Research Center
    Name of recruitment center - Persian: مطب دکتر منصور سیاوش، مرکز تحقیقات غدد
    Full name of responsible person - English: Dr. Mansour Siavash Dastjerdi
    Full name of responsible person - Persian: دکتر منصور سیاوش دستجردی
    Street address - English: Isfahan, Ferdowsi St., Palestine Crossroads, Hakim Building, First Floor, Unit 5
    Street address - Persian: صفهان- خیابان فردوسی- چهارراه فلسطین- ساختمان حکیم- طبقه اول واحد 5
    City - English: Esfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8187698191
    Phone: +98 31 3223 2472
    Fax:
    Email: masiavash@yahoo.com
    Web page address:
    Name of recruitment center - English: Endocrine Research Center
    Name of recruitment center - Persian: مرکز تحقیقات غدد
    Full name of responsible person - English: Dr. Mansour Siavash Dastjerdi
    Full name of responsible person - Persian: دکتر منصور سیاوش دستجردی
    Street address - English: Khoram Street
    Street address - Persian: خیابان خرم
    City - English: Esfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8187698191
    Phone: +98 31 3223 2472
    Fax:
    Email: masiavash@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: Gholamreza Askari
    Full name of responsible person - Persian: غلامرضا عسکری
    Street address - English: Hezar Jarib St, Isfahan University of Medical Sciences
    Street address - Persian: خیابان هزار جریب، دانشگاه علوم پزشکی اصفهان
    City - English: Esfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174673461
    Phone: +98 31 3792 3171
    Fax:
    Email: askari@mui.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Gholamreza Askari
    Full name of responsible person - Persian: غلامرضا عسکری
    Street address - English: Hezar Jarib Street
    Street address - Persian: خیابان هزار جریب
    City - English: Esfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174673461
    Phone: +98 31 3792 3171
    Fax:
    Email: askari@mui.ac.ir
    Web page address:

Protocol summary

Study aim
Evaluation of the effectiveness of propolis dietary supplement on metabolic syndrome and its components in patients with metabolic syndrome: a randomized, controlled, double-blinded clinical trial
Design
A randomized, double-blind, clinical trial with a parallel groups design of 60 patients.
Settings and conduct
In this study, we select 60 individuals with metabolic syndrome who refer to clinics affiliated to the university of medical science, Esfahan and we will divide them in to 2 groups receiving propolis supplement and placebo. For proper blindness, the drug and placebo will be exactly the same and non of the participants and researchers will be aware of them until the end of the study. At the beginning of the study and 12 weeks after the intervention, biochemical evaluation, anthropometry and blood pressure measurement will be performed. During this period, all patients receive healthy lifestyle recommendations
Participants/Inclusion and exclusion criteria
inclusion criteria: patients with metabolic syndrome according to NCEP-ATP III, adults 20-60 years old, willingness to participate, ability to read and write; criteria for not entering: pregnancy or lactation, having certain diseases, tobacco and alcohol consumption, adherence to a weight-loss diet or physical activity program, insulin injection, Change in the type and dosage of medication from 3 months before entering the study
Intervention groups
Intervention groups: 2 tablets of 350 mg daily containing 250 mg of propolis extract before lunch and dinner, for 12 weeks. Placebo groups: 2 tablets daily containing 350 mg of microcrystalline cellulose before lunch and dinner
Main outcome variables
Fasting blood sugar; Triglyceride; Total cholesterol; High-density lipoprotein; Low-density lipoprotein; Insulin; HOMA-IR index; Weight; Waist; BMI; Blood pressure; C- reactive protein, Quality of life, Mood status

General information

Reason for update
Change in some exclusion criteria
Acronym
IRCT registration information
IRCT registration number: IRCT20121216011763N49
Registration date: 2020-12-23, 1399/10/03
Registration timing: registered_while_recruiting

Last update: 2022-08-09, 1401/05/18
Update count: 1
Registration date
2020-12-23, 1399/10/03
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of propolis dietary supplement on metabolic syndrome and its components in patients with metabolic syndrome: a randomized, controlled, double-blinded clinical trial
Public title
Evaluation of the effectiveness of propolis dietary supplement on metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with metabolic syndrome according to (NCEP-ATP III) Willingness to participate in the study Adults 20-60 years old Having the ability to read and write
Exclusion criteria:
Pregnancy and lactation Having the following disease: Malignancies or cancer, type I diabetes, nephrotic syndrome, kidney and lung disease, biliary disease, and HIV Sensitivity to bee products Adherence a weight loss diet or physical activity program Tobacco and alcohol consumption Insulin injection Change in the type and dosage of medication from 3 months before entering the study
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will conduct based on the permuted block randomization method. Each block will have a capacity for 4 subjects. Then, within each block, subjects will be randomly assigned to treatment or placebo. Random assignment will be done using a random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
For proper blinding, the drug and placebo will be exactly the same in size, color, odor, and packing, and none of the participants and researchers will be aware of them until the end of the study, except for the pharmacist.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-12-06, 1399/09/16
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.595

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
Homeostasis model assessment insulin resistance (HOMA-IR)
Timepoint
At the beginning of the study and 12 weeks after supplementation
Method of measurement
( fasting plasma glucose × fasting Insulin)/22.5

Secondary outcomes

1

Description
Serum insulin
Timepoint
At the beginning of the study and 12 weeks after supplementation
Method of measurement
Laboratory method

2

Description
Fasting blood sugar
Timepoint
At the beginning of the study and 12 weeks after supplementation
Method of measurement
Colorimetric analysis method and by autoanalyzer

3

Description
Triglyceride
Timepoint
At the beginning of the study and 12 weeks after supplementation
Method of measurement
Colorimetric analysis method and by autoanalyzer

4

Description
Cholesterol
Timepoint
At the beginning of the study and 12 weeks after supplementation
Method of measurement
Colorimetric analysis method and by autoanalyzer

5

Description
High-density lipoprotein (HDL)
Timepoint
At the beginning of the study and 12 weeks after supplementation
Method of measurement
Colorimetric analysis method and by autoanalyzer

6

Description
Low density lipoprotein (LDL)
Timepoint
At the beginning of the study and 12 weeks after supplementation
Method of measurement
Colorimetric analysis method and by autoanalyzer

7

Description
C-reactive protein (CRP)
Timepoint
At the beginning of the study and 12 weeks after supplementation
Method of measurement
Immunoturbidimetric

8

Description
Blood pressure
Timepoint
At the beginning of the study and 12 weeks after supplementation
Method of measurement
Barometer

9

Description
Weight
Timepoint
At the beginning of the study and 12 weeks after supplementation
Method of measurement
Digital scale

10

Description
Waist Circumference
Timepoint
At the beginning of the study and 12 weeks after supplementation
Method of measurement
Non-elastic meter

11

Description
Body mass index (BMI)
Timepoint
At the beginning of the study and 12 weeks after supplementation
Method of measurement
Weight/ (Height*Height)

12

Description
Quality of Life
Timepoint
At the beginning of the study and 12 weeks after supplementation
Method of measurement
A validated questionnaire- 36-Item Short Form Health Survey (SF-36)

13

Description
Mood status (Stress, depression, anxiety)
Timepoint
At the beginning of the study and 12 weeks after supplementation
Method of measurement
A validated questionnaire DASS-21

Intervention groups

1

Description
Intervention group: Daily consumption of two 350 mg capsules that each capsule contains 250 mg of propolis extract and 100 mg of safe and ineffective combination of microcrystalline cellulose as a supplemental formulation, made by Reyhan Naghsh Jahan Pharmaceutical Company, Isfahan before lunch and dinner for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: Daily consumption of two placebo capsules that each capsule contains 350 mg of microcrystalline cellulose, made by Reyhan Naghsh Jahan Pharmaceutical Company, Isfahan before lunch and dinner for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine Research Center
Full name of responsible person
Dr. Mansour Siavash Dastjerdi
Street address
Khoram Street
City
Esfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3223 2472
Email
masiavash@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Hezar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Fax
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Ph.D of nutrition, Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar Jarib
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir

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
Undecided - It is not yet known if there will be 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 can be shared after people are not identified.
When the data will become available and for how long
Access 1 year after publishing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data will be available in order to know the details of the research and any secondary analysis of the data is subject to the permission of the project owner.
From where data/document is obtainable
Hezar Jarib St., Isfahan University of Medical Sciences, Nutrition college, Department of Community Nutrition, Dr. Gholamreza Askari, Askari@mui.ac.ir
What processes are involved for a request to access data/document
The communication will be possible through the electronic mail given in the previous section.
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