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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.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20161102030649N1
Enrollment
60
Registered
2018-01-26
Start date
2017-09-23
Completion date
Unknown
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease, coronary artery disease (CAD). Atherosclerotic heart disease of native coronary artery with unstable angina pectoris

Interventions

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

Sponsors

Vice Chancellor for research of Tarbiat Modares University, Faculty of Medical Science.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Cardiac events Gestation or Menopause Recent taking systemic medication (other than the usual drug for hypertension, dyslipidemia, and hyperglycemia)

Design outcomes

Primary

MeasureTime frame
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.;NF?B 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 t

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Abedimanesh

Tarbiat Modares University

s.abedymanesh@modares.ac.ir+98 21 8288 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026