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IRCT20240125060804N1 IRCT 2024-01-31 Islamic Azad University Investigating the effects of zinc in reducing the risk of diabetes and cardiovascular diseases Investigating the effect of zinc supplementation on the levels of oxidative stress and inflammation markers and glucose homeostasis in overweight or obese patients with metabolic syndrome 2024-02-19 anticipated 60 Complete https://irct.ir/trial/75185 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: At the beginning of the study, after applying the inclusion and exclusion criteria, patients will be divided into two groups to receive zinc supplements (30 patients) and placebo (30 patients). Randomization will be done using a computer-generated random number table, Blinding description: Blinding of the clinical researcher and patients will be done. The zinc supplement and placebo will be delivered to the clinical researcher with identical appearance. 3 Metabolic syndrome. Intervention 1: Intervention group: Patients with metabolic syndrome receiving zinc supplementation. The dose of zinc received will be 30 mg orally once a day. Supplementation will be done for 12 weeks. Intervention 2: Control group: Patients with metabolic syndrome receiving placebo. The placebo will be starch tablets, similar in appearance to zinc tablets, and will be taken once a day for 12 weeks. Yes - There is a plan to make this available What will be shared: All information related to the study can be shared When: Access starts six months after the results are published. To whom: Researchers working in academic and scientific institutions Conditions: Access to the data will be given to people working in scientific and academic institutions only by citing scientific reasons, and all statistical analyzes on the data will be allowed. Where to obtain: To receive the data, contact Mostafa Vaghari- Tabari via email mostafavaghari@yahoo.com or vagharim@tbzmed.ac.ir How to obtain: After correspondence with the responsible person, the scientific reasons for the data request will be discussed with all members of the research team, and if the reasons are scientific and there is no legal prohibition, the data will reach the requester within a week. Comments:
public Mostafa Vaghari-Tabari
At the end of Modares Alley, Jamal Alley, Keshavarz Street
Babol Iran (Islamic Republic of) 4717975666 +98 11 3223 2963 vagharim@tbzmed.ac.ir Mazandaran University of Medical Sciences scientific Mostafa Vaghari-Tabari
At the end of Modares Alley, Jamal Alley, Keshavarz Street
Babol Iran (Islamic Republic of) 4717975666 +98 11 3223 2963 vagharim@tbzmed.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age over 18 to 70 years old Definite diagnosis of metabolic syndrome based on clinical symptoms and laboratory findings. Overweight or obesity (BMI above 25) Obtaining written informed consent from patients 18 years 70 years Both Taking zinc supplements at least three months before starting the study The need to take blood sugar and lipid lowering drugs according to the doctor's opinion History of other diseases related to oxidative stress and inflammation such as cardiovascular diseases, autoimmune diseases, types of diabetes, IBD, asthma, cancer, kidney and liver diseases, Infectious diseases Smoking and alcohol consumption E88.81 Metabolic syndrome Prevention Placebo Intervention group: Patients with metabolic syndrome receiving zinc supplementation. The dose of zinc received will be 30 mg orally once a day. Supplementation will be done for 12 weeks. Control group: Patients with metabolic syndrome receiving placebo. The placebo will be starch tablets, similar in appearance to zinc tablets, and will be taken once a day for 12 weeks. Serum insulin. Timepoint: Before the intervention, after the end of the intervention period. Method of measurement: Commercial ELISA kit. Serum MDA. Timepoint: Before the intervention, after the end of the intervention period. Method of measurement: TBARS method. Serum zinc. Timepoint: Before the intervention, after the end of the intervention period. Method of measurement: Commercial spectrophotometry kit. Serum total antioxidant capacity. Timepoint: Before the intervention, after the end of the intervention period. Method of measurement: FRAP method. Serum lipid profile. Timepoint: Before the intervention, after the end of the intervention period. Method of measurement: Commercial spectrophotometry kit. Serum CRP. Timepoint: Before the intervention, after the end of the intervention period. Method of measurement: Commercial kit. Serum TNF-α. Timepoint: Before the intervention, after the end of the intervention period. Method of measurement: Commercial ELISA kit. HbA1C levels. Timepoint: Before the intervention, after the end of the intervention period. Method of measurement: Commercial kit. Serum fasting glucose. Timepoint: Before the intervention, after the end of the intervention period. Method of measurement: Commercial kit. Body Mass Index. Timepoint: Before the intervention, after the end of the intervention period. Method of measurement: Scales, meter. Waist circumference. Timepoint: Before the intervention, after the end of the intervention period. Method of measurement: Meter. Islamic Azad University Approved 2024-01-13 Research Ethics Committees of Islamic Azad University, Shahrood Branch Islamic Azad University, Shahrood branch, University blvd Shahrood Semnan Iran (Islamic Republic of)