Effect of Supplementation with Crocetin (Saffron carotenoids) on Antioxidant Indices, Inflammatory index and Serum Leptin Concentration in Patients with Coronary Artery Diseases: A Double-Blind Randomized Clinical Trial
To determine the effect of Crostin on antioxidant indices, inflammatory index and serum leptin in coronary artery patients.
Design
Randomised, parallel group trial with blinded outcome assessment. Random numbers generated by Sealed Envelope at an external site.
Settings and conduct
Double-blind randomized clinical controlled trial will be carried out trough parallel design, with 50 patients who are diagnosed by an cardiologist in the medical centers of Ahvaz University of Medical Sciences. Patients will be divided into two groups of 25 patients receiving Crocetin and placebo .Patients will receive 1 capsul of 125 mg daily Crocetin (10 mg dry crocetin powder ) and placebo that are similar in appearance to the intervention for 8 weeks. Cans containing capsules will be coded by a nonresearcher as allocation concealment and distributed to the patients in each block randomly.
Participants/Inclusion and exclusion criteria
Inclusion :
Coronary artery occlusion disease
Age 40 to 65
BMI 25-35
Willing to participate
Exclusion :
Any heart attack
Lactation / pregnancy
Allergic reactions
Incidence of infectious disease or side effect during the study,
Taking new medications
Irregular usage of intervention capsule
Unwillingness to continue
Intervention groups
The patient with block randomization divided into two groups of 25 receiving 125 mg capsul of Crocetin( 1 dry 10 mg crostin powder with corn starch filler) and placebo (corn starch) daily.Supplements are given 1 hr before lunch for 8 weeks.All capsul are in the same shape and size.
Main outcome variables
Hs- CRP, Antioxidant indices, leptin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220902055853N2
Registration date:2023-05-18, 1402/02/28
Registration timing:prospective
Last update:2023-05-18, 1402/02/28
Update count:0
Registration date
2023-05-18, 1402/02/28
Registrant information
Name
fatemeh borazjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3321 9570
Email address
fa.borazjani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-09, 1402/03/19
Expected recruitment end date
2023-12-10, 1402/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Supplementation with Crocetin (Saffron carotenoids) on Antioxidant Indices, Inflammatory index and Serum Leptin Concentration in Patients with Coronary Artery Diseases: A Double-Blind Randomized Clinical Trial
Public title
Effect of Saffron in Coronary Artery Diseases
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Coronary artery occlusion disease
Willingness to participate in the study
Age range of 40 to 65 years
BMI 25-35
Exclusion criteria:
Having heart attack
lactation or pregnancy
Having any infectious disease
Chang the usual medications
Irregular consumption of interventional capsules
Taking food supplement, vitamin and mineral for at least in the last 3 months
Participate in another trial simultaneously
Having an Allergic reaction to interventional herb
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization is blocks.The entry of each patient into the Intervention or Control group is distributed in each group using the Randomization method with the help of four blocks. This work is done by
using a sequence of random numbers generated by Sealed Envelope Ltd. 2022. Create a blocked randomization list. [Online] Available from:https://www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double-blinded, hence the researcher and participants will not know which group they are belong to. For blinding, intervention and placebo capsules are provided in similar shapes, colors, and sizes. These capsules are coded (A and B) by a person other than the investigators and then are given to the participants. Until the end of study and after analyzing of data, investigators are not informed about the intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Ahvaz Jundishapur university of medical sciences,Ahvaz,Iran
Street address
University of Medical Sciences and Health Care Services Ahvaz, Research and Technology Development Deputy Building, Nutrition and Metabolic Diseases Research Cente
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-04-08, 1402/01/19
Ethics committee reference number
IR.AJUMS.REC.1402.024
Health conditions studied
1
Description of health condition studied
Coronary Artery Diseases
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Weight measured with minimal clothing and no shoes with an accuracy of 0.1 Using a kilogram scale
10
Description
Body mass index
Timepoint
At the beginning and end of study
Method of measurement
Weight in kilograms divided by height in meters squared.kg/m2
Intervention groups
1
Description
Intervention group: supplementation of Crocetin (10 mg dry crocetin powder, 1 capsules of 125 mg daily) one hour before lunch for period of 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: Daily 1 capsules of 125 mg containing corn starch one hour before lunch for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical centers of Ahvaz city
Full name of responsible person
Faezeh Moeini Badi
Street address
Golestan Medical Sciences Dormitory, Golestan Boulevard, Ahvaz, Khouzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 912 639 9027
Email
moeinibadifaezeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoosh Zakerkish
Street address
Ahvaz Jundishapur University of Medical Sciences، Deputy of research and technology .Ahvaz, Iran.
City
َAhvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
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
Ahvaz University of Medical Sciences
Full name of responsible person
Faezeh Moeini Badi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Medical Sciences Dormitory, Golestan Boulevard, Ahvaz, Khouzestan, Iran
City
َAhvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3336 2414
Email
moeinibadifaezeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Borazjani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
University of Medical Sciences and Health Care Services Ahvaz, Research and Technology Development Deputy Building, Nutrition and Metabolic Diseases Research Cente
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2665
Email
fa.borazjani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Faezeh Moeini Badi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Medical Sciences Dormitory, Golestan Boulevard, Ahvaz, Khouzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3311 2665
Email
moeinibadifaezeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Effect of Supplementation with crocetin (Saffron carotenoids) on Antioxidant Indices, Inflammatory index and Serum Leptin Concentration in Patients with Coronary Artery Diseases
When the data will become available and for how long
After the publication of the article
To whom data/document is available
All
Under which criteria data/document could be used
ُStudy
From where data/document is obtainable
Fatemeh Borazjani
What processes are involved for a request to access data/document