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IRCT20121216011763N49 IRCT 2020-12-23 Esfahan University of Medical Sciences Evaluation of the effectiveness of propolis dietary supplement on metabolic syndrome 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 2020-12-21 anticipated 60 Complete https://irct.ir/trial/52826 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Metabolic syndrome. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Data can be shared after people are not identified. When: Access 1 year after publishing results To whom: Researchers working in academic and scientific institutions Conditions: 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. Where to obtain: Hezar Jarib St., Isfahan University of Medical Sciences, Nutrition college, Department of Community Nutrition, Dr. Gholamreza Askari, Askari@mui.ac.ir How to obtain: The communication will be possible through the electronic mail given in the previous section. Comments:

public Gholamreza Askari

Hezar Jarib Street

Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3171 askari@mui.ac.ir Esfahan University of Medical Sciences scientific Gholamreza Askari

Hezar Jarib Street

Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3171 askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 20 years 60 years Both 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 E88.81 Metabolic syndrome Treatment - Drugs Placebo 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. 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 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. Serum insulin. Timepoint: At the beginning of the study and 12 weeks after supplementation. Method of measurement: Laboratory method. Fasting blood sugar. Timepoint: At the beginning of the study and 12 weeks after supplementation. Method of measurement: Colorimetric analysis method and by autoanalyzer. Triglyceride. Timepoint: At the beginning of the study and 12 weeks after supplementation. Method of measurement: Colorimetric analysis method and by autoanalyzer. Cholesterol. Timepoint: At the beginning of the study and 12 weeks after supplementation. Method of measurement: Colorimetric analysis method and by autoanalyzer. 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. 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. C-reactive protein (CRP). Timepoint: At the beginning of the study and 12 weeks after supplementation. Method of measurement: Immunoturbidimetric. Blood pressure. Timepoint: At the beginning of the study and 12 weeks after supplementation. Method of measurement: Barometer. Weight. Timepoint: At the beginning of the study and 12 weeks after supplementation. Method of measurement: Digital scale. Waist Circumference. Timepoint: At the beginning of the study and 12 weeks after supplementation. Method of measurement: Non-elastic meter. Body mass index (BMI). Timepoint: At the beginning of the study and 12 weeks after supplementation. Method of measurement: Weight/ (Height*Height). 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). 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. Esfahan University of Medical Sciences Approved 2020-12-06 Ethics Committee of Isfahan University of Medical Sciences Hezar Jarib Street Esfahan Isfehan Iran (Islamic Republic of)