Protocol summary

Summary
Background: Coronary artery occlusion is the main cause of myocardial infarction and death in Iran. Saffron is a native spice which is consume abundantly in our country. Saffron and its two main carotenoids; crocin and crocetin have strong antioxidant capacity. They can also prevent or delay atherosclerosis plaque formation through different signaling pathways so improve cardiovascular health. Objectives and main outcomes: The aim of this study is to investigate the effects of saffron aqueous extract, crocin and crocetin on expression of some genes involved in the plaque formation including sirtuin-1, AMPK, NF-kappa B, MCP-1 in peripheral blood mononuclear cells, variables of lipid profile. Design, setting and conduct: It is an eight weeks double blind clinical trial conducted on 60 patients from Shahid Madani hospital. Patients were randomly divided into four groups. The questionnaires related to general information, the three-day food record, appetite levels, anthropometric measurements and quality of life will be completed. For biochemical tests, 20 ml blood will be collected after overnight fasting, at baseline and at the end of the study. Major eligibility criteria: Any overweight and obese 40 to 65 years old patients with coronary artery disease could participate. Intervention: The first group will receive two capsules containing 15 mg of saffron extract, the second group will receive two capsules containing 15 mg crocin, the third will get capsules contain 5 mg crocetin twice daily and the fourth group will receive placebo

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201512102017N26
Registration date: 2016-01-17, 1394/10/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Tabriz University of Medical Sciences, Nutrition Research Center
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of saffron aqueous extract and its main carotenoids (crocin and crocetin) on expression of some genes involved in atherosclorosis in peripheral blood mononuclear cells of patients with coronary heart disease
Public title
Effects of saffron extract and its two main carotenoids (crocin, crocetin) on coronary heart disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: overweight and obese patients with coronary heart disease; lack of cancers; autoimmune diseases and infectious; lack of allergy; no history of antioxidant supplements during the past six months; willingness to participate in this research project Exclusion criteria: Any MI; Catching any infectious disease during the study; Menopause; pregnancy and lactation; expose with any side effects during the study; Unwillingness to continue participation in the study
Age
From 40 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Tabriz University of Medical Sciences
Street address
Third floor, Central building(2), Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Approval date
2015-11-23, 1394/09/02
Ethics committee reference number
TBZMED.REC.1394.739

Health conditions studied

1

Description of health condition studied
Coronary Heart Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Sirtuin-1 expression
Timepoint
at baseline and after 2 months at the end of study
Method of measurement
real time-PCR

2

Description
AMPK expression
Timepoint
at baseline and after 2 months at the end of study
Method of measurement
real time-PCR

3

Description
NF-kappa B expression
Timepoint
at baseline and after 2 months at the end of study
Method of measurement
real time-PCR

4

Description
MCP-1 expression
Timepoint
at baseline and after 2 months at the end of study
Method of measurement
real time-PCR

5

Description
plasma levels of MCP-1
Timepoint
at baseline and after 2 months at the end of study
Method of measurement
elisa (ng/ml)

6

Description
lipid profile variables
Timepoint
at baseline and after 2 months at the end of study
Method of measurement
measurements of TC, LDL-c, HDL-c, TG by autoanalyzer

Secondary outcomes

1

Description
quality of life score
Timepoint
at baseline and after 2 months at the end of study
Method of measurement
Mac new quality of life questionnaire

2

Description
food intake
Timepoint
at baseline and after 2 months at the end of study
Method of measurement
three days food records

3

Description
appetite levels
Timepoint
at baseline and after 2 months at the end of study
Method of measurement
visual analouge scale

4

Description
anthropometric indices
Timepoint
at baseline and after 2 months at the end of study
Method of measurement
measurements of height, waist and hip circumference with tape measure , weight with Seca scale

Intervention groups

1

Description
crocin capsule, 15 mg, twice daily
Category
Treatment - Other

2

Description
saffron aqueous extract capsule, 15 mg, twice daily
Category
Treatment - Other

3

Description
crocetin capsule, 5 mg, twice daily
Category
Treatment - Other

4

Description
placebo, twice daily
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Medical Research Training Center
Full name of responsible person
Dr Mohammadreza Taban Sadeghi
Street address
Daneshgah Street, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research of Tabriz University of Medical Sciences, Nutrition Research Center
Full name of responsible person
prof. Alireza Ostadrahimi
Street address
Third floor, Central building(2), Tabriz University of Medical Scienes, Golgasht avenue
City
Tabriz
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 Tabriz University of Medical Sciences, Nutrition Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nasim Abedimanesh
Position
Ph. D. candidate in Nutrition
Other areas of specialty/work
Street address
Nutrition Faculty, Attar Neyshaburi street, Golgasht avenue
City
Tabriz
Postal code
Phone
+98 41 3335 7584
Fax
Email
abedimaneshn@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nutrition faculty, Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Position
proffesor
Other areas of specialty/work
Street address
Nutrition faculty, Attar Neyshaburi street, Golgasht avenue
City
Tabriz
Postal code
Phone
+98 41 3335 7584
Fax
Email
ostadrahimi@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nutrition Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Nasim Abedimanesh
Position
Ph.D. candidate in Nutrition
Other areas of specialty/work
Street address
Nutrition Faculty, Attar neyshaburi Avenue, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3335 7582
Fax
Email
abedimaneshn@tbzmed.ac.ir; an_abedymanesh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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