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IRCT20220902055853N2 IRCT 2023-05-18 Ahvaz University of Medical Sciences Effect of Saffron in Coronary Artery Diseases Effect of Supplementation with Crocetin (Saffron carotenoids) on Antioxidant Indices, Inflammatory index and Serum Leptin Concentration in Patients with Coronary Artery Diseases: A Double-Blind Randomized Clinical Trial 2023-06-09 anticipated 50 Complete https://irct.ir/trial/70012 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Method of randomization is blocks.The entry of each patient into the Intervention or Control group is distributed in each group using the Randomization method with the help of four blocks. This work is done by using a sequence of random numbers generated by Sealed Envelope Ltd. 2022. Create a blocked randomization list. [Online] Available from:https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: The study will be double-blinded, hence the researcher and participants will not know which group they are belong to. For blinding, intervention and placebo capsules are provided in similar shapes, colors, and sizes. These capsules are coded (A and B) by a person other than the investigators and then are given to the participants. Until the end of study and after analyzing of data, investigators are not informed about the intervention and control groups. 3 Coronary Artery Diseases. Intervention 1: Intervention group: supplementation of Crocetin (10 mg dry crocetin powder, 1 capsules of 125 mg daily) one hour before lunch for period of 8 weeks. Intervention 2: Control group: Daily 1 capsules of 125 mg containing corn starch one hour before lunch for 8 weeks. Yes - There is a plan to make this available What will be shared: Effect of Supplementation with crocetin (Saffron carotenoids) on Antioxidant Indices, Inflammatory index and Serum Leptin Concentration in Patients with Coronary Artery Diseases When: After the publication of the article To whom: All Conditions: ُStudy Where to obtain: Fatemeh Borazjani How to obtain: E mail Comments:
public Faezeh Moeini Badi
Golestan Medical Sciences Dormitory, Golestan Boulevard, Ahvaz, Khouzestan, Iran
َAhvaz Iran (Islamic Republic of) 6135815751 +98 61 3336 2414 moeinibadifaezeh@gmail.com Ahvaz University of Medical Sciences scientific Fatemeh Borazjani
University of Medical Sciences and Health Care Services Ahvaz, Research and Technology Development Deputy Building, Nutrition and Metabolic Diseases Research Cente
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 2665 fa.borazjani@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Coronary artery occlusion disease Willingness to participate in the study Age range of 40 to 65 years BMI 25-35 40 years 65 years Both Having heart attack lactation or pregnancy Having any infectious disease Chang the usual medications Irregular consumption of interventional capsules Taking food supplement, vitamin and mineral for at least in the last 3 months Participate in another trial simultaneously Having an Allergic reaction to interventional herb I25.1 Atherosclerotic heart disease of native coronary artery Treatment - Drugs Placebo Intervention group: supplementation of Crocetin (10 mg dry crocetin powder, 1 capsules of 125 mg daily) one hour before lunch for period of 8 weeks. Control group: Daily 1 capsules of 125 mg containing corn starch one hour before lunch for 8 weeks. Hs-CRP. Timepoint: At the beginning and end of study. Method of measurement: Serum sample. Superoxide dismutase (SOD). Timepoint: At the beginning and end of study. Method of measurement: Serum sample. Malondialdehyde (MDA). Timepoint: At the beginning and end of study. Method of measurement: Serum sample. Catalase(CAT). Timepoint: At the beginning and end of study. Method of measurement: Serum sample. Leptin. Timepoint: At the beginning and end of study. Method of measurement: Serum sample. Plasma atherogenic index. Timepoint: At the beginning and end of study. Method of measurement: Calculated by log (TG/HDL-C). Systolic and Diastolic Blood Pressure. Timepoint: At the beginning and end of study. Method of measurement: Mercury sphygmomanometer. Physical activity. Timepoint: At the beginning and end of study. Method of measurement: International Physical ActivityQuestionnaire. Dietary intake (Energy, Carbohydrate, Fat, Protein). Timepoint: At the beginning and end of study. Method of measurement: Using Nutritionist IV software. Weight. Timepoint: At the beginning and end of study. Method of measurement: Weight measured with minimal clothing and no shoes with an accuracy of 0.1 Using a kilogram scale. Body mass index. Timepoint: At the beginning and end of study. Method of measurement: Weight in kilograms divided by height in meters squared.kg/m2. Ahvaz University of Medical Sciences Approved 2023-04-08 Ethic committee of Ahvaz Jundishapur university of medical sciences,Ahvaz,Iran University of Medical Sciences and Health Care Services Ahvaz, Research and Technology Development Deputy Building, Nutrition and Metabolic Diseases Research Cente Ahvaz Khouzestan Iran (Islamic Republic of)