Protocol summary
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Study aim
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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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Design
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A randomized, double-blind, clinical trial with a parallel groups design of 60 patients.
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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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
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Reason for update
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Change in some exclusion criteria
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Acronym
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IRCT registration information
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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
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Registration date
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2020-12-23, 1399/10/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-12-21, 1399/10/01
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Expected recruitment end date
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2021-09-23, 1400/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Evaluation of the effectiveness of propolis dietary supplement on metabolic syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-12-06, 1399/09/16
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1399.595
Health conditions studied
1
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Description of health condition studied
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Metabolic syndrome
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ICD-10 code
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E88.81
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ICD-10 code description
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Metabolic syndrome
Primary outcomes
1
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Description
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Homeostasis model assessment insulin resistance (HOMA-IR)
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Timepoint
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At the beginning of the study and 12 weeks after supplementation
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Method of measurement
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( fasting plasma glucose × fasting Insulin)/22.5
Secondary outcomes
1
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Description
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Serum insulin
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Timepoint
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At the beginning of the study and 12 weeks after supplementation
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Method of measurement
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Laboratory method
2
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Description
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Fasting blood sugar
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Timepoint
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At the beginning of the study and 12 weeks after supplementation
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Method of measurement
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Colorimetric analysis method and by autoanalyzer
3
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Description
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Triglyceride
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Timepoint
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At the beginning of the study and 12 weeks after supplementation
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Method of measurement
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Colorimetric analysis method and by autoanalyzer
4
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Description
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Cholesterol
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Timepoint
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At the beginning of the study and 12 weeks after supplementation
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Method of measurement
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Colorimetric analysis method and by autoanalyzer
5
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Description
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High-density lipoprotein (HDL)
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Timepoint
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At the beginning of the study and 12 weeks after supplementation
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Method of measurement
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Colorimetric analysis method and by autoanalyzer
6
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Description
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Low density lipoprotein (LDL)
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Timepoint
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At the beginning of the study and 12 weeks after supplementation
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Method of measurement
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Colorimetric analysis method and by autoanalyzer
7
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Description
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C-reactive protein (CRP)
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Timepoint
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At the beginning of the study and 12 weeks after supplementation
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Method of measurement
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Immunoturbidimetric
8
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Description
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Blood pressure
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Timepoint
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At the beginning of the study and 12 weeks after supplementation
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Method of measurement
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Barometer
9
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Description
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Weight
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Timepoint
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At the beginning of the study and 12 weeks after supplementation
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Method of measurement
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Digital scale
10
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Description
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Waist Circumference
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Timepoint
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At the beginning of the study and 12 weeks after supplementation
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Method of measurement
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Non-elastic meter
11
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Description
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Body mass index (BMI)
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Timepoint
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At the beginning of the study and 12 weeks after supplementation
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Method of measurement
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Weight/ (Height*Height)
12
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Description
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Quality of Life
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Timepoint
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At the beginning of the study and 12 weeks after supplementation
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Method of measurement
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A validated questionnaire- 36-Item Short Form Health Survey (SF-36)
13
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Description
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Mood status (Stress, depression, anxiety)
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Timepoint
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At the beginning of the study and 12 weeks after supplementation
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Method of measurement
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A validated questionnaire DASS-21
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Data can be shared after people are not identified.
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When the data will become available and for how long
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Access 1 year after publishing results
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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Hezar Jarib St., Isfahan University of Medical Sciences, Nutrition college, Department of Community Nutrition, Dr. Gholamreza Askari, Askari@mui.ac.ir
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What processes are involved for a request to access data/document
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The communication will be possible through the electronic mail given in the previous section.
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Comments
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