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.
1. The effects of saffron aqua-extraction and its carotenoids (crocin and crocetin) on the anthropometric indices in atherosclerotic patients in comparison with together and control group.
2. The effects of saffron aqua-extraction and its carotenoids (crocin and crocetin) on the plasma proteomic pattern in atherosclerotic patients in comparison with together and control group.
3. The effects of saffron aqua-extraction and its carotenoids (crocin and crocetin) on the LOX-1 Gene expression and cytosolic levels of miRNA-223 of PBMCs in atherosclerotic patients in comparison with together and control group.
4. The effects of saffron aqua-extraction and its carotenoids (crocin and crocetin) on the plasma homocysteine levels in atherosclerotic patients in comparison with together and control group.
Design
In this double-blind parallel clinical trial, with consideration to inclusion and exclusion criteria, 60 atherosclerotic adult patients will be randomly divided into four groups (15 patients in each) that will receive, once a day, a capsule containing 30 mg SAE/ 30 mg crocin/ 10 mg crocetin/or placebo. Before and after 8 weeks, blood samples will be collected by venipuncture into the tubes coated with EDTA. A part of the plasma will be delabuminated and be applied for two-dimensional gel electrophoresis. Then, the plasma proteome patterns of the patients before and after intervention will be compared using Melanie software and statistical analysis. The spots with significant changes will be compared with the standard proteome patterns for characterization and identification. The other part of plasma will be used for quantification of Homocysteine levels using an ELISA kit. Peripheral blood mononuclear cells will be isolated from whole blood of the patients and were used for total RNA extraction and cDNA synthesis, LOX-1 gene, and miRNA-223 expression will be determined using Real-Time PCR. The data obtained from all of the groups will be compared before and after intervention and with together and with the placebo group with suitable statistical analysis method(s).
Settings and conduct
This study is a double blind clinical trial at the field of nutraceuticals and their effects on prevention and treatment of atherosclerosis and will be done in the Shahid Madani Cardiovascular Disease Center of Tabriz,Iran. laboratory analysis will be done at the university of Tarbiat Modares, Tehran, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Overweight and obese atherosclerotic patients of both gender in the range of 45-60 years old have permission to enter into this study.
Exclusion criteria: patients with other diseases such as diabetes, autoimmune disease, infectious disease, and kidney or liver dysfunctions have not eligible to enter into this study as well as smokers.
Intervention groups
60 atherosclerotic adult patients will be randomly divided in four groups (15 patients in each) that will receive, once a day, a capsule containing 30 mg SAE/ 30 mg crocin/ 10 mg crocetin/or placebo.
Main outcome variables
The main outcome measures are LOX-1 and miRNA-223 Gene expression and plasma proteome chenges.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161102030649N1
Registration date:2018-01-26, 1396/11/06
Registration timing:registered_while_recruiting
Last update:2018-01-26, 1396/11/06
Update count:2
Registration date
2018-01-26, 1396/11/06
Registrant information
Name
Saeed Abedimanesh
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 0000
Email address
s.abedymanesh@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-24, 1396/07/02
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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:
Overweight and obese patients
Patients don't suffering from cancer, auto-immune, allergy, Diabetes, kidney and liver disease.
patients don't have any anti-oxidant intake within the last 6 months.
Exclusion criteria:
Myocardial infarction during the intervention.
Get infected during the intervention.
Gestation or Menopause
Any kinds of adverse effects or allergic reactions occur during the intervention.
Unwilling to continue the Participation.
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
More than 1 sample in each individual
Number of samples in each individual:
2
Twice blood collection will be don for each individual, first, just before intervention, second, just after 2 month intervention.
Actual sample size reached:
60
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.
Placebo
Used
Assignment
Parallel
Other design features
Based on achieved results, our purpose would be treatment.
Atherosclerotic heart disease of native coronary artery with unstable angina pectoris
Primary outcomes
1
Description
LOX-1 Gene expression in PBMCs.
Timepoint
day 0 and 60.
Method of measurement
Real time PCR
2
Description
miRNA-223 copy number in PBMCs
Timepoint
day 0 and 60.
Method of measurement
Real time PCR
3
Description
Plasma Homocystein concentration
Timepoint
day 0 and 60.
Method of measurement
ELISA
4
Description
Plasma Proteome patern
Timepoint
day 0 and 60.
Method of measurement
2-D Gel Electrophoresis
Secondary outcomes
1
Description
Body Mass Index (BMI)
Timepoint
Day 0 and 60
Method of measurement
height and weight measurement and calculate with formula
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.