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.
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Double-blinded parallel randomized clinical trial with 60 patients and at phase 2
A double-blinded parallel randomized clinical trial with 89 patients and at phase 2
DoubleA double-blinded parallel randomized clinical trial with 6089 patients and at phase 2
کار آزمایی بالینی تصادفی دو سو کور موازی با 60 نفر بیمار و در فاز 2
کار آزمایی بالینی تصادفی دو سو کور موازی با 89 نفر بیمار و در فاز 2
کار آزمایی بالینی تصادفی دو سو کور موازی با 6089 نفر بیمار و در فاز 2
60 patients in 4 groups (15 patients in each) will randomly receive one capsule containing saffron aqua extract (30 mg) or crocin (30 mg) or crocetin (10 mg) or placebo, once a day, for 60 days.
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.
6089 patients in 4 groups (15 patients in each) 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.
در مطالعه حاضر 60 بیمار بطور تصادفی در چهار گروه 15 نفری دسته بندی می شوند. این چهار گروه روزانه یک کپسول حاوی عصاره آبی زعفران (30 mg) یا کروسین (30 mg) یا کروستین (10 mg) یا دارونما را به مدت 60 روز دریافت میکنند.
در مطالعه حاضر 89 بیمار بطور تصادفی در چهار گروه دسته بندی می شوند. این چهار گروه روزانه یک کپسول حاوی عصاره آبی زعفران (30 میلی گرم، 20 بیمار) یا کروسین (30 میلی گرم، 24 بیمار) یا کروستین (10 میلی گرم، 24 بیمار) یا دارونما (21 بیمار) را به مدت 60 روز دریافت میکنند.
در مطالعه حاضر 6089 بیمار بطور تصادفی در چهار گروه 15 نفری دسته بندی می شوند. این چهار گروه روزانه یک کپسول حاوی عصاره آبی زعفران (30 mgمیلی گرم، 20 بیمار) یا کروسین (30 mgمیلی گرم، 24 بیمار) یا کروستین (10 mgمیلی گرم، 24 بیمار) یا دارونما (21 بیمار) را به مدت 60 روز دریافت میکنند.
General information
60
89
6089
Protocol summary
Study aim
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.
Design
A double-blinded parallel randomized clinical trial with 89 patients and at phase 2
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Overweight/obese CAD patients of both gender (45-60 year old, BMI: 25-35 Kg/m2)
Exclusion criteria: Cardiac events, Gestation, Menopause
Intervention groups
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.
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.
Public title
Effect of saffron aqua-extract and its carotenoids in atherosclerotic patients.
Purpose
Supportive
Inclusion/Exclusion 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:
Cardiac events
Gestation or Menopause
Recent taking systemic medication (other than the usual drug for hypertension, dyslipidemia, and hyperglycemia)
Age
From 40 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
89
Randomization (investigator's opinion)
Randomized
Randomization description
randomization will be done with software.
Blinding (investigator's opinion)
Double blinded
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.
Atherosclerotic heart disease of native coronary artery with unstable angina pectoris
Primary outcomes
1
Description
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
2
Description
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
3
Description
Plasma Homocystein concentration
Timepoint
Before the intervention (day 0), and 8 weeks after the intervention (day 60)
Method of measurement
ELISA
4
Description
Plasma Proteome patern
Timepoint
Before the intervention (day 0), and 8 weeks after the intervention (day 60)
Method of measurement
2-D Gel Electrophoresis
5
Description
Serum concentrations of h-FABP
Timepoint
Before the intervention (day 0), and 8 weeks after the intervention (day 60)
Method of measurement
ELISA
6
Description
Serum concentrations of MCP-1
Timepoint
Before the intervention (day 0), and 8 weeks after the intervention (day 60)
Method of measurement
ELISA
7
Description
Serum concentrations of ICAM-1
Timepoint
Before the intervention (day 0), and 8 weeks after the intervention (day 60)
Method of measurement
ELISA
8
Description
Serum concentrations of VCAM-1
Timepoint
Before the intervention (day 0), and 8 weeks after the intervention (day 60)
Method of measurement
ELISA
9
Description
fasting blood glucose (FBG)
Timepoint
Before the intervention (day 0), and 8 weeks after the intervention (day 60)
Method of measurement
colorimetric based kit
10
Description
Lipid profile
Timepoint
Before the intervention (day 0), and 8 weeks after the intervention (day 60)
Method of measurement
colorimetric based kit
11
Description
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
12
Description
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
13
Description
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
14
Description
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
15
Description
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
Secondary outcomes
1
Description
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
2
Description
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
3
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
3
Description
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.
Category
Treatment - Other
4
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Medical research training center, Tabriz university of medical science.
Full name of responsible person
Dr.Mohammad Reza Tabani.
Street address
Tabriz University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 3900
Fax
Email
afsaris@tbzmed.ac.ir
Web page address
http://madanihosp.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tarbiat Modares University, Faculty of Medical Science.
Full name of responsible person
Dr. Yaagub Fath Allahi
Street address
Gisha Bridge, Jalal Al Ahmad Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
14115-116
Phone
+98 21 8288 0000
Email
s.abedy88@Gmail.com
Web page address
http://modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tarbiat Modares University, Faculty of Medical Science.
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Saeed Abedimanesh
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Gisha Bridge, Jalal Al Ahmad highway, TMU university
City
Tehran
Province
Tehran
Postal code
14115-116
Phone
+98 21 8288 0000
Email
s.abedymanesh@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University - Faculty of Medical Science
Full name of responsible person
Seyede Zahra Bathaie
Position
Full professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Gisha Bridge, Jalal Al Ahmad highway, Tehran.
City
Tehran
Province
Tehran
Postal code
14115-116
Phone
+98 21 8288 4567
Email
zbatha2000@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Saeed Abedimanesh
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Gisha Bridge, Jalal Al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
14115-116
Phone
+98 21 8288 0000
Email
s.abedymanesh@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
only primary outcome measure will be shared after intervention.
When the data will become available and for how long
Starting 1 year after publication.
To whom data/document is available
Documents/Information will be shared only for people working in academic institutions.
Under which criteria data/document could be used
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.