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IRCT20180201038585N6 IRCT 2020-02-22 Bagheiat-allah University of Medical Sciences Effect of garlic in improvement of metabolic syndrome The effect of garlic powder supplementation on Metabolic Syndrome components, Fatty liver index, Intestinal function and Appetite Control in patients with metabolic syndrome 2019-11-20 anticipated 90 Complete https://irct.ir/trial/44501 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization lists were computer-generated by a statistician, then, participants assigned to the groups of the study. A trained person, randomly allocated and assigned the participants to study groups, Blinding description: intervention and randomization were performed through a random allocation list by a member of the research team as the only blinded individual to the assignment. Other members of the research team (including team leader and study coordinator), as well as all participants, were randomly assigned to groups and intervention and remained blind until the end of the. N/A METABOLIC SYNDROME. Intervention 1: Intervention group: The intervention group will be consume 4 tablets of 400 miligrams per day garlic. Intervention 2: Control group: The control group will be consume 4 tablets of 400 miligrams per day placebo in addition to usual treatment for three months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public karim Parastouei
Mullasadra Ave, Vannak Sq,Tehran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8248 3264 karimparastouei@gmail.com Bagheiat-allah University of Medical Sciences scientific Karim Parastouei
Mullasadra Ave, Vannak Sq, Tehran
Tehran Iran (Islamic Republic of) 1435916471 +981435916471 Karimparastouei@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Age more than 18 y Diagnosis of metabolic syndrome 18 years no limit Both Kidney disease Cardiovascular disease Type 1 and 2 diabetes Cancers Using blood pressure lower drugs Using blood sugar lower drugs Using anticoagulant drugs Psychiatric disorders Pregnancy and Lactation Allergy to garlic E00-E90 Endocrine, nutritional and metabolic diseases Treatment - Drugs Placebo Intervention group: The intervention group will be consume 4 tablets of 400 miligrams per day garlic. Control group: The control group will be consume 4 tablets of 400 miligrams per day placebo in addition to usual treatment for three months. HDL cholesterol. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Enzymatic method, mg/dl. Weight. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Scale, kg. Body mass index. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Weight(kg)\[height(m)]2 , kg\m2. Waist Circumference. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: BIA, cm. Body fat percent. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: BIA. Triglyceride. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Enzymatic method, mg/dl. LDL cholesterol. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Enzymatic method, mg/dl. Total cholesterol. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Enzymatic method, mg/dl. Systolic blood pressure. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Mercury sphygmomanometer, mmHg. Diastolic blood pressure. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Mercury sphygmomanometer, mmHg. Fatty liver index. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Formula. Quantity of appetite. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: VAS questionnaire. Intestinal function. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Bristol stool questionaire. Fasting blood sugar. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Enzymatic method, IU\ Lit. Serum insulin. Timepoint: at the beginning of the study (before intervention), and 12 weeks after intervention. Method of measurement: Radioimmunoassay. HOMA-IR. Timepoint: at the beginning of the study (before intervention), and 12 weeks after intervention. Method of measurement: Formula. Cardiometabolic index. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Formula. Atherogenic index of plasma. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Formula. Atherogenic coefficient. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Formula. Castelli risk index I. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Formula. Castelli risk index II. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Formula. Visceral adiposity index. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Formula. Lipid aaccumulation product. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Formula. Waist to height ratio. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Formula. ABSI Index. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Formula. BRI index. Timepoint: at the beginning of the study (before intervention), 6 and 12 weeks after intervention. Method of measurement: Formula. Bagheiat-allah University of Medical Sciences Approved 2019-07-09 Ethics committee of bahgeyatlah University of Medical Sciences Moulla Sadra Ave , Vannak Square Tehran Tehran Iran (Islamic Republic of)