Protocol summary
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Study aim
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Investigation of the effects of saffron aqua-extraction and its carotenoids (crocin and crocetin) on the fasting blood glucose (FBG), lipid profile, and serum concentration of homocysteine, MCP-1, ICAM-1, VCAM-1, and h-FABP and genes expressions of SIRT1, LOX-1, MCP-1, AMPK, NFκB, and miR-223 and anthropometric indices, quality of life assessment, left ventricular ejection fraction and the plasma proteomic pattern in atherosclerotic patients in comparison with together and control group.
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Design
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A double-blinded parallel randomized clinical trial with 89 patients and at phase 2
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Settings and conduct
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This study is done in the Shahid Madani Cardiovascular Center of Tabriz. Biochemical and Proteomics tests will be carried out at Tarbiat Modarres University.
Before and after interventions, blood samples will be collected. A part of the plasma will be deabuminated and be applied for two-dimensional gel electrophoresis. Then, the plasma proteome patterns of the patients before and after intervention will be compared using a software. ELISA, Colorimetry, and Real-Time PCR will be used for Measuring of serum concentration of homocysteine and proteins, lipid profile and FBG, and genes expressions, respectively. Finally, all data will be analyzed via suitable statistical analysis methods.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Overweight/obese CAD patients of both gender (45-60 year old, BMI: 25-35 Kg/m2)
Exclusion criteria: Cardiac events, Gestation, Menopause
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Intervention groups
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89 patients in 4 groups will randomly receive one capsule containing saffron aqua extract (30 mg; N: 20) or crocin (30 mg; N: 24) or crocetin (10 mg, N: 24) or placebo (N: 21), once a day, for 60 days.
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Main outcome variables
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FBG
lipid profile
Plasma concentrations of Hcy, MCP-1, ICAM-1, VCAM-1, h-FABP
Genes expressions of SIRT1, LOX-1, MCP-1, AMPK, NFκB, miR-223
LVEF
Proteomic pattern
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20161102030649N1
Registration date:
2018-01-26, 1396/11/06
Registration timing:
registered_while_recruiting
Last update:
2019-02-17, 1397/11/28
Update count:
2
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Registration date
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2018-01-26, 1396/11/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-09-23, 1396/07/01
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Expected recruitment end date
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2018-03-06, 1396/12/15
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Actual recruitment start date
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2017-09-24, 1396/07/02
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Actual recruitment end date
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2018-03-15, 1396/12/24
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Trial completion date
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2018-03-15, 1396/12/24
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Scientific title
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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.
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Public title
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Effect of saffron aqua-extract and its carotenoids in atherosclerotic patients.
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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:
Cardiac events
Gestation or Menopause
Recent taking systemic medication (other than the usual drug for hypertension, dyslipidemia, and hyperglycemia)
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Age
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From 40 years old to 65 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
Actual sample size reached:
89
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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randomization will be done with software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-09-23, 1396/07/01
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Ethics committee reference number
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IR.TMU.REC.1396.610
Health conditions studied
1
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Description of health condition studied
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Cardiovascular disease, coronary artery disease (CAD)
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ICD-10 code
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I25.110
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ICD-10 code description
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Atherosclerotic heart disease of native coronary artery with unstable angina pectoris
Primary outcomes
1
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Description
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LOX-1 gene relative expression in PBMCs.
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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Real time PCR
2
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Description
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miRNA-223 copy number in PBMCs
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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Real time PCR
3
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Description
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Plasma Homocystein concentration
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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ELISA
4
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Description
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Plasma Proteome patern
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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2-D Gel Electrophoresis
5
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Description
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Serum concentrations of h-FABP
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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ELISA
6
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Description
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Serum concentrations of MCP-1
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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ELISA
7
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Description
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Serum concentrations of ICAM-1
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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ELISA
8
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Description
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Serum concentrations of VCAM-1
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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ELISA
9
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Description
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fasting blood glucose (FBG)
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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colorimetric based kit
10
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Description
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Lipid profile
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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colorimetric based kit
11
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Description
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NFκB gene relative expression in PBMCs.
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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Real time PCR
12
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Description
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SIRT-1 gene relative expression in PBMCs.
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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Real time PCR
13
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Description
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MCP-1 gene relative expression in PBMCs.
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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Real time PCR
14
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Description
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AMPK gene relative expression in PBMCs.
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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Real time PCR
15
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Description
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left Ventricular Ejection Fraction (LVEF)
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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Echocardiographic examinations were performed using Vivid 7 Pro (GE, USA) instrument
Secondary outcomes
1
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Description
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Body Mass Index (BMI)
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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height and weight measurement and calculate with formula
2
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Description
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waist to hip circumference (WHR)
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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spring-loaded tape measure
3
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Description
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Quality of life assessment
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Timepoint
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Before the intervention (day 0), and 8 weeks after the intervention (day 60)
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Method of measurement
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Mac new quality of life questionnaire for ischemic heart patients
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
3
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Description
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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.
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Category
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Treatment - Other
4
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for research of Tarbiat Modares University, Faculty of Medical Science.
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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only primary outcome measure will be shared after intervention.
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When the data will become available and for how long
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Starting 1 year after publication.
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To whom data/document is available
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Documents/Information will be shared only for people working in academic institutions.
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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Saeed Abedimanesh
Tell: 00989141145213
E-mail: s.abedymanesh@modares.ac.ir
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What processes are involved for a request to access data/document
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Applicants must explain their conditions by email, after acceptance they will receive the documents.
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Comments
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