Effects of saffron extract and its two main carotenoids (crocin, crocetin) on coronary heart disease
Phase 2
- Conditions
- Coronary Heart Disease.Atherosclerotic heart disease
- Registration Number
- IRCT201512102017N26
- Lead Sponsor
- Vice-chancellor for Research of Tabriz University of Medical Sciences, Nutrition Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.