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IRCT20200106046022N2 IRCT 2021-07-22 Esfahan University of Medical Sciences Effects of sumac on inflammatory status, insulin resistance and antioxidant status in metabolic syndrome The effect of Rhus Coriaria (Sumac) supplementation on inflammatory status, insulin resistance and antioxidant status in patients with metabolic syndrome: a randomized, triple-blind crossover clinical intervention 2021-07-23 anticipated 40 Complete https://irct.ir/trial/57095 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: An unaware person that is not involved in study, will perform block randomization using the website of” WWW.randomization.com” and based on the code assigned to each participants. Such that, subjects will be randomly divided in two groups of intervention and control with a 1: 1 allocation ratio. The preparation of sumac and placebo capsules with codes A and B will be determined by a person not involved in sampling and data collection and analysis and researchers don't know how to distribute it. In each intervention period, group A will be given code A capsules and group B will be given code B capsules, Blinding description: In this study, Sumac and Lactosehr II will be replaced in single-color and uniform 500 mg capsules. Participants, researchers and statisticians will not be aware of the type of capsules. 2-3 metabolic syndrome. Intervention 1: Intervention group: 500 mg capsules of sumac daily, two with food for 6 weeks in the first period of the intervention. In the second period of the intervention of this group, they are in the control group. The capsules are filled with sumac powder powdered by the researcher due to the reduction of counterfeits. Intervention 2: Control group: Lactose 500 mg capsules daily with food for 6 weeks in the first period of the intervention. In the second period of the intervention, this group is in the intervention group. The capsules are filled by the researcher with lactose. 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 Parvane Saneei
School of Nutrition, Hezar Jerib Ave, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8168913868 +98 31 3792 3159 saneeip@yahoo.com Esfahan University of Medical Sciences scientific Saneei Parvane
School of Nutrition, Hezar Jerib Ave, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8168913868 +98 31 3792 3159 saneeip@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Adults 20-55 years old Metabolic syndrome based on modified ATPIII criteria 20 years 55 years Both Having cardiovascular, liver, kidney, thyroid and diabetes diseases Pregnancy and lactation Follow a special diet Use of drugs that affect appetite, blood pressure, inflammation, fat metabolism and carbohydrates Use of multivitamin-mineral supplements, fatty acids and herbal remedies E88.81 Metabolic syndrome Treatment - Drugs Placebo Intervention group: 500 mg capsules of sumac daily, two with food for 6 weeks in the first period of the intervention. In the second period of the intervention of this group, they are in the control group. The capsules are filled with sumac powder powdered by the researcher due to the reduction of counterfeits. Control group: Lactose 500 mg capsules daily with food for 6 weeks in the first period of the intervention. In the second period of the intervention, this group is in the intervention group. The capsules are filled by the researcher with lactose. Insulin resistance (Fasting blood sugar, Insulin, HOMA- IR،QUICKI). Timepoint: At the beginning and end of each Six-week intervention. Method of measurement: Existing commercial kits. Antioxidant status (MDA,CTL,SOD). Timepoint: At the beginning and end of each Six-week intervention. Method of measurement: En Existing commercial kits. Inflammation status (CRP). Timepoint: At the beginning and end of each Six-week intervention. Method of measurement: Existing commercial kits. Waist Circumference. Timepoint: At the beginning and end of each intervention period. Method of measurement: Meters irreversible. Weight. Timepoint: At the beginning and end of each intervention period. Method of measurement: Digital Balance. BMI. Timepoint: At the beginning and end of each intervention period. Method of measurement: Divide the weight by the square of the height. Esfahan University of Medical Sciences Approved 2021-05-29 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib Ave Isfahan Isfehan Iran (Islamic Republic of)