Protocol summary

Summary
The aim of this study is to determine a synergic effect of Astaxanthin and alpha linolenic acid on some of the inflammation cytokines markers, lipid profile, serum levels of leptin and adiponectin in patients with mild to moderate coronary artery stenosis. Design: This is a double-blind clinical trial including 44 patients with Cardiovascular disease, who will be referred to the Golestan hospital’ clinic. Subjects will be followed for a period of 8 weeks. Setting, conduct and participants: 44 patients aged over 18 years with 30 -70 persent stenosis in coronary artery who do not have a specific disease ,will be enrolled in this study. Patients will be randomly divided into two groups using random numbers table. Those patients who do not meet study requirements during the study will be excluded. Interventions: The case group (included 22 patients) will receive a supplement containing of 4mg Astaxanthin and 300 mg alphalinolenic acid, one tablet daily and the control group (included 22 patients) will use placebo tablets, one tablet daily for 8 weeks. To assess the dietary factors affecting the inflammatory parameters in patients, the total amount of energy, macronutrients and micronutrients will be determined at the beginning and the end of the study. For this purpose three-day recall food questionnaire will be completed by the expert in nutrition science. Patients’ weight will be measured with minimal clothes, without shoes by a digital scale. Main outcome measures: The main variables including body fat percentage; blood pressure and biochemical parameters will be measured and reported at the beginning and the end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050327727N1
Registration date: 2017-02-09, 1395/11/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-09, 1395/11/21
Registrant information
Name
Elmira Yousefi
Name of organization / entity
Ahvaz Jundishapour University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 3416 4726
Email address
yousefi.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Science
Expected recruitment start date
2016-06-28, 1395/04/08
Expected recruitment end date
2017-06-10, 1396/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effect of supplement containing Astaxanthin and alpha linolenic acid with placebo on serum levels of leptin and adiponectin, hs-CRP, miocardio vascular adhesion factors, nitric oxide and lipid profile in patients with mild to moderate coronary artery stenosis
Public title
effect of supplement containing Astaxanthin and alpha linolenic acid in coronary artery stenosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study; age range over 18 years; Patients who are suffering from ischemic heart disease with 30 -70 percent stenosis and are not candidates for coronary angioplasty. Exclusion criteria: having chronic disease; Blood or immunologic disorders; Hypothyroidism; Cardiogenic shock; Myocardial infarction with elevation of ST-segment; Pregnant and lactating women.
Age
From 18 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 44
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 of Ahvaz Jundishapur University of Medical Sciences
Street address
Ethics Committee, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Khuozestan, Ahvaz
City
Ahvaz
Postal code
Approval date
2016-10-25, 1395/08/04
Ethics committee reference number
IR.AJUMS.REC.1395.451

Health conditions studied

1

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

Primary outcomes

1

Description
Adiponectin
Timepoint
Befor intervention and two months after intervention
Method of measurement
ELISA Test

2

Description
Leptin
Timepoint
Befor intervention and two months after intervention
Method of measurement
ELISA Test

3

Description
vascular cell adhesion molecule 1
Timepoint
Befor intervention and two months after intervention
Method of measurement
ELISA Test

4

Description
E-selectin
Timepoint
Befor intervention and two months after intervention
Method of measurement
ELISA Test

5

Description
C-reactive protein
Timepoint
Befor intervention and two months after intervention
Method of measurement
ELISA Test

6

Description
Nitric Oxide
Timepoint
Befor intervention and two months after intervention
Method of measurement
ELISA Test

7

Description
Malondialdehyde
Timepoint
Befor intervention and two months after intervention
Method of measurement
ELISA Test

8

Description
High-density lipoprotein
Timepoint
Befor intervention and two months after intervention
Method of measurement
spectrophotometer Test

9

Description
Low-density lipoprotein
Timepoint
Befor intervention and two months after intervention
Method of measurement
spectrophotometer Test

10

Description
Triglycerides
Timepoint
Befor intervention and two months after intervention
Method of measurement
spectrophotometer Test

11

Description
Total cholesterol
Timepoint
Befor intervention and two months after intervention
Method of measurement
spectrophotometer Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: in this group, one oral supplement tablet containing 4 mg of Astaxanthin and 300mg alpha-Linolenic acid, produced in USA is prescribed. It should be used daily for 8 weeks
Category
Treatment - Drugs

2

Description
Control group: in this group, a placebo pill produced in the form of oil capsule by Barij Company containing paraffin, is prescribed. It should be used daily for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Golestan Hospital
Full name of responsible person
Elmira Yousefi
Street address
Clinic, Golestan Hospital, Golestan Ave, Khuozestan, Ahvaz
City
Ahwaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Behzad sharif Makhmalzadeh
Street address
Vice chancellor for research, Ahvaz Jundishapur University of Medical Science, Golestan Ave, Khouzestan, Ahvaz
City
Ahvaz
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, Ahvaz Jundishapour University of Medical Sciences
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
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Elmira yousefi
Position
Ms.c student of Nutrition Science
Other areas of specialty/work
Street address
Dept of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science, Golestan Ave, Khouzestan, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3373 8330
Fax
Email
yousefi.e@ajums.ac.ir; eyousefi41@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Majid Mohammad Shahi
Position
Assistant professor
Other areas of specialty/work
Street address
Dept of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science, Golestan Ave, Khouzestan, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3373 8330
Fax
Email
shahi334@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Elmira Yousefi
Position
Ms.C student of nutrition science
Other areas of specialty/work
Street address
Dept of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science, Golestan Ave, Khuozestan, Ahvaz
City
Ahvaz
Postal code
Phone
00
Fax
Email
eyousefi41@yahoo.com
Web page address

Sharing plan

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