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IRCT201512102017N26 IRCT 2016-01-17 Vice-chancellor for Research of Tabriz University of Medical Sciences, Nutrition Research Center Effects of saffron extract and its two main carotenoids (crocin, crocetin) on coronary heart disease Effects of saffron aqueous extract and its main carotenoids (crocin and crocetin) on expression of some genes involved in atherosclorosis in peripheral blood mononuclear cells of patients with coronary heart disease 2016-01-20 anticipated 60 Complete https://irct.ir/trial/1639 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. 2 Coronary Heart Disease. Intervention 1: crocin capsule, 15 mg, twice daily. Intervention 2: saffron aqueous extract capsule, 15 mg, twice daily. Intervention 3: crocetin capsule, 5 mg, twice daily. Intervention 4: placebo, twice daily.
public Nasim Abedimanesh
Nutrition Faculty, Attar Neyshaburi street, Golgasht avenue
Tabriz Iran (Islamic Republic of) +98 41 3335 7584 abedimaneshn@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Alireza Ostadrahimi
Nutrition faculty, Attar Neyshaburi street, Golgasht avenue
Tabriz Iran (Islamic Republic of) +98 41 3335 7584 ostadrahimi@tbzmed.ac.ir Nutrition faculty, Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: overweight and obese patients with coronary heart disease; lack of cancers; autoimmune diseases and infectious; lack of allergy; no history of antioxidant supplements during the past six months; willingness to participate in this research project Exclusion criteria: Any MI; Catching any infectious disease during the study; Menopause; pregnancy and lactation; expose with any side effects during the study; Unwillingness to continue participation in the study 40 years 65 years Both I25.1 Atherosclerotic heart disease Treatment - Other Treatment - Other Treatment - Other Placebo crocin capsule, 15 mg, twice daily saffron aqueous extract capsule, 15 mg, twice daily crocetin capsule, 5 mg, twice daily placebo, twice daily Sirtuin-1 expression. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: real time-PCR. AMPK expression. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: real time-PCR. NF-kappa B expression. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: real time-PCR. MCP-1 expression. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: real time-PCR. Plasma levels of MCP-1. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: elisa (ng/ml). Lipid profile variables. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: measurements of TC, LDL-c, HDL-c, TG by autoanalyzer. Quality of life score. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: Mac new quality of life questionnaire. Food intake. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: three days food records. Appetite levels. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: visual analouge scale. Anthropometric indices. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: measurements of height, waist and hip circumference with tape measure , weight with Seca scale. Vice-chancellor for Research of Tabriz University of Medical Sciences, Nutrition Research Center Approved 2015-11-23 Ethics Committee Tabriz University of Medical Sciences Third floor, Central building(2), Tabriz University of Medical Sciences, Golgasht street Tabriz Iran (Islamic Republic of)