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IRCT20161102030649N1 IRCT 2018-01-26 Vice Chancellor for research of Tarbiat Modares University, Faculty of Medical Science. Effect of saffron aqua-extract and its carotenoids in atherosclerotic patients. Study of the effect of saffron aqueous extract and its carotenoids (crocin and crocetin) on plasma proteome pattern, expression of LOX1 gene and miRNA223, and serum homocystein levels in atherosclerotic patients. 2017-09-23 anticipated 60 Complete https://irct.ir/trial/28051 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: randomization will be done with software, Blinding description: In this study, patients, investigators who administer drug/placebo to patients, statistical and laboratory analyzer technicians as well as healthcare center personnel, are blind using the coding system before starting intervention. Researchers who involved in the writing of paper and final conclusion would have permission to access decoded information in order to have the best interpretations and scientific results. 2 Cardiovascular disease, coronary artery disease (CAD). Intervention 1: Intervention group: 1. In this group of study, each patient receives one capsule of 30 mg saffron aqua-extract (made by Dr. Bathaie Lab. Tarbiat Modares University, Faculty of clinical biochemistry) for 2 months. Intervention 2: Intervention group: 2. In this group of study, each patient receives one capsule of 30 mg crocin (made by Dr. Bathaie Lab. Tarbiat Modares University, Faculty of clinical biochemistry) for 2 months. Intervention 3: Intervention group: 3. In this group of study, each patient receives one capsule of 10 mg crocetin (made by Dr. Bathaie Lab. Tarbiat Modares University, Faculty of clinical biochemistry) for 2 months. Intervention 4: Control group: 4. In this group of study, each patient receives one placebo capsule (made by Dr. Bathaie's Lab. Tarbiat Modares University, Faculty of clinical biochemistry) for 2 months. Yes - There is a plan to make this available What will be shared: only primary outcome measure will be shared after intervention. When: Starting 1 year after publication. To whom: Documents/Information will be shared only for people working in academic institutions. Conditions: Researchers at the field of cardiovascular disease can achieve our documents and information. but they must named our researchers as the co-authors in their publications. Where to obtain: Saeed Abedimanesh Tell: 00989141145213 E-mail: s.abedymanesh@modares.ac.ir How to obtain: Applicants must explain their conditions by email, after acceptance they will receive the documents. Comments:
public Saeed Abedimanesh
Gisha Bridge, Jalal Al Ahmad highway, TMU university
Tehran Iran (Islamic Republic of) 14115-116 +98 21 8288 0000 s.abedymanesh@modares.ac.ir Tarbiat Modares University scientific Seyede Zahra Bathaie
Gisha Bridge, Jalal Al Ahmad highway, Tehran.
Tehran Iran (Islamic Republic of) 14115-116 +98 21 8288 4567 zbatha2000@yahoo.com Tarbiat Modares University - Faculty of Medical Science Iran (Islamic Republic of) subjects with coronary artery disease 40-65 years old overweight and obese (BMI 25-35 kg/m2) subjects without a history of myocardial infarction (MI) No tobacco or alcohol consumption who had no symptoms of cancer, auto-immune, allergy, infection, kidney and liver diseases Not consuming of antioxidants supplement and vitamins for the last six months. Signing up the informed consent form 40 years 65 years Both Cardiac events Gestation or Menopause Recent taking systemic medication (other than the usual drug for hypertension, dyslipidemia, and hyperglycemia) I25.110 Atherosclerotic heart disease of native coronary artery with unstable angina pectoris Treatment - Other Treatment - Other Treatment - Other Placebo Intervention group: 1. In this group of study, each patient receives one capsule of 30 mg saffron aqua-extract (made by Dr. Bathaie Lab. Tarbiat Modares University, Faculty of clinical biochemistry) for 2 months. Intervention group: 2. In this group of study, each patient receives one capsule of 30 mg crocin (made by Dr. Bathaie Lab. Tarbiat Modares University, Faculty of clinical biochemistry) for 2 months. Intervention group: 3. In this group of study, each patient receives one capsule of 10 mg crocetin (made by Dr. Bathaie Lab. Tarbiat Modares University, Faculty of clinical biochemistry) for 2 months. Control group: 4. In this group of study, each patient receives one placebo capsule (made by Dr. Bathaie's Lab. Tarbiat Modares University, Faculty of clinical biochemistry) for 2 months. LOX-1 gene relative expression in PBMCs. Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: Real time PCR. MiRNA-223 copy number in PBMCs. Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: Real time PCR. Plasma Homocystein concentration. Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: ELISA. Plasma Proteome patern. Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: 2-D Gel Electrophoresis. Serum concentrations of h-FABP. Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: ELISA. Serum concentrations of MCP-1. Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: ELISA. Serum concentrations of ICAM-1. Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: ELISA. Serum concentrations of VCAM-1. Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: ELISA. Fasting blood glucose (FBG). Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: colorimetric based kit. Lipid profile. Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: colorimetric based kit. NFκB gene relative expression in PBMCs. Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: Real time PCR. SIRT-1 gene relative expression in PBMCs. Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: Real time PCR. MCP-1 gene relative expression in PBMCs. Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: Real time PCR. AMPK gene relative expression in PBMCs. Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: Real time PCR. Left Ventricular Ejection Fraction (LVEF). Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: Echocardiographic examinations were performed using Vivid 7 Pro (GE, USA) instrument. Body Mass Index (BMI). Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: height and weight measurement and calculate with formula. Waist to hip circumference (WHR). Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: spring-loaded tape measure. Quality of life assessment. Timepoint: Before the intervention (day 0), and 8 weeks after the intervention (day 60). Method of measurement: Mac new quality of life questionnaire for ischemic heart patients. Vice Chancellor for research of Tarbiat Modares University, Faculty of Medical Science. Approved 2017-09-23 Ethic committee of Tarbiat Modares University Tarbiat Modares University, Gisha Bridg, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)