The effects of Astaxanthin supplementation on serum levels of Sirtuin1، TNF-α، metabolic parameters, body composition and nutritional status in patients with coronary artery disease.
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Primary outcomes
#1
Lipid profile included, HDL-LDL-TG-TC
Lipid profile
Lipid profile included, HDL-LDL-TG-TC
پروفایل لیپیدی شامل ، HDL - LDL- TG - TC
پروفایل لیپیدی
پروفایل لیپیدی شامل ، HDL - LDL- TG - TC
#2
Glycemic indexes include FBS, insulin, HOMA-IR
Glycemic indexes
Glycemic indexes include FBS, insulin, HOMA-IR
شاخص های گلایسمیک شامل FBS, insulin, HOMA-IR
شاخص های گلایسمیک
شاخص های گلایسمیک شامل FBS, insulin, HOMA-IR
#3
empty
Oxidative stress indices
Oxidative stress indices
empty
شاخص های استرس اکسیداتیو
شاخص های استرس اکسیداتیو
empty
At the beginning and end of the study after 8 weeks
At the beginning and end of the study after 8 weeks
empty
ابتدا و انتهای مطالعه بعد از 8 هفته
ابتدا و انتهای مطالعه بعد از 8 هفته
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Measurement of serum levels of Total antioxidant capacity (TAC) and malondialdehyde (MDA) and Superoxide dismutase by spectrophotometry
Measurement of serum levels of Total antioxidant capacity (TAC) and malondialdehyde (MDA) and Superoxide dismutase by spectrophotometry
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اﻧﺪازه ﮔﯿﺮی ﻇﺮﻓﯿﺖ ﺗﺎم آﻧﺘﯽ اﮐﺴﯿﺪاﻧﯽ (TAC) وﻣﺎﻟﻮن دی آﻟﺪﺋﯿﺪ (MDA) و سوپراکسید دیسموتاز در ﺳﺮم ﺑﻪ روش اسپکتروفتومتری
اﻧﺪازه ﮔﯿﺮی ﻇﺮﻓﯿﺖ ﺗﺎم آﻧﺘﯽ اﮐﺴﯿﺪاﻧﯽ (TAC) وﻣﺎﻟﻮن دی آﻟﺪﺋﯿﺪ (MDA) و سوپراکسید دیسموتاز در ﺳﺮم ﺑﻪ روش اسپکتروفتومتری
#4
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plasminogen activator inhibitor-1
plasminogen activator inhibitor-1
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مهارکننده فعال کننده پلاسمینوژن نوع یک
مهارکننده فعال کننده پلاسمینوژن نوع یک
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At the beginning and end of the study after 8 weeks
At the beginning and end of the study after 8 weeks
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ابتدا و انتهای مطالعه بعد از 8 هفته
ابتدا و انتهای مطالعه بعد از 8 هفته
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Measurement with ELISA kit
Measurement with ELISA kit
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اندازه گیری با کیت الایزا
اندازه گیری با کیت الایزا
Secondary outcomes
#1
En At the beginning and end of the study after 8 weeks
At the beginning and end of the study after 8 weeks
En At the beginning and end of the study after 8 weeks
#2
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depression severity
depression severity
empty
شدت افسردگی
شدت افسردگی
empty
At the beginning and end of the study after 8 weeks
At the beginning and end of the study after 8 weeks
empty
ابتدا و انتهای مداخله پس از 8 هفته
ابتدا و انتهای مداخله پس از 8 هفته
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Beck Depression Inventory scale
Beck Depression Inventory scale
empty
پرسشنامه بک
پرسشنامه بک
#3
empty
blood pressure
blood pressure
empty
فشار خون
فشار خون
empty
At the beginning and end of the study after 8 weeks
At the beginning and end of the study after 8 weeks
empty
ابتدا و انتهای مداخله پس از 8 هفته
ابتدا و انتهای مداخله پس از 8 هفته
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Using a mercury barometer
Using a mercury barometer
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با استفاده از فشارسنج جیوه ای
با استفاده از فشارسنج جیوه ای
Protocol summary
Study aim
Determination of the effect of Astaxanthin supplementation on serum levels of Sirtuin1، TNF-α، metabolic parameters and nutritional status in patients with coronary artery disease
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 44 patients. PASS software was used for randomization.
Settings and conduct
Eligible patients will be selected by a cardiologist and will be included in the study
Blinding will be done for researchers and patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients in the age range of 65-40 years, 25 <BMI <35, Proof of 50% stenosis in at least one of the coronary arteries on angiography, Ability and willingness to cooperate in the project
Exclusion criteria: Smoking, alcohol, and hookah, Hypothyroidism and Hyperthyroidism, Uncontrolled diabetes, History of myocardial infarction
Cardiac dysfunction (Class 3 and 4), Valvular heart disease, Kidney failure, Pregnant and lactating women, Taking herbal supplements and antioxidants in the last three months
Intervention groups
The first group will receive 12 mg of astaxanthin per day and the second group will receive (placebo) 12 mg of microcrystalline cellulose per day. The duration of the intervention will be two months. Both groups will receive a weight loss diet (deduction of 500 kcal)
Main outcome variables
serum levels of Sirtuin 1, Tumour Necrosis Factor-alpha (TNF alpha), Lipid profile( LDL-C ،HDL-C ،TGT، TC), insulin, fasting blood sugar and HOMA-IR(Homeostatic Model Assessment for Insulin Resistance)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201227049857N1
Registration date:2021-02-19, 1399/12/01
Registration timing:registered_while_recruiting
Last update:2021-06-16, 1400/03/26
Update count:2
Registration date
2021-02-19, 1399/12/01
Registrant information
Name
Marzieh Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3348 1180
Email address
mheidari.96@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-17, 1399/11/29
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Astaxanthin supplementation on serum levels of Sirtuin1، TNF-α، metabolic parameters, body composition and nutritional status in patients with coronary artery disease.
Public title
The effect of astaxanthin supplementation in patients with coronary artery disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 65-40 years
BMI between 25-35
Proof of 50% stenosis in at least one of the major coronary arteries in angiography
Ability, and willingness to collaborate on the project
Exclusion criteria:
Smoking, alcohol and hookah consumption
Hypothyroidism and Hyperthyroidism
Uncontrolled diabetes
History of myocardial infarction
Cardiac dysfunction (Class 3 and 4)
Valvular heart disease
Kidney failure
Pregnant and lactating women
Taking herbal supplements and antioxidants in the last three months
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals of the two groups will be placed in one of the intervention or control groups, which will be based on blocks created by random allocation software. The random sequence generated is kept in a safe place and performed by an independent person who is blind to the trial during the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
During the study, neither participants nor researchers will know that each person is in the intervention or control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2021-02-16, 1399/11/28
Ethics committee reference number
IR.TBZMED.REC.1399.1060
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum level of Sirtuin1
Timepoint
At the beginning and end of the study after 8 weeks
Method of measurement
Measurement with ELISA kit
2
Description
Serum level TNF-∝
Timepoint
At the beginning and end of the study after 8 weeks
Method of measurement
Measurement with ELISA kit
3
Description
Lipid profile
Timepoint
At the beginning and end of the study after 8 weeks
Method of measurement
Enzyme kits and the Friedwald equation
4
Description
Glycemic indexes
Timepoint
At the beginning and end of the study after 8 weeks
Method of measurement
ELISA and spectrophotometer
5
Description
Anthropometric Indices
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Measurement of height and weight without shoes and with minimum clothes on, by Seca stadiometer and scale, respectively. Measurement of the waist and hip circumference by a tape measure and body mass index (BMI) by dividing weight (kg) by height squared (m2) and measurement of body composition
6
Description
Oxidative stress indices
Timepoint
At the beginning and end of the study after 8 weeks
Method of measurement
Measurement of serum levels of Total antioxidant capacity (TAC) and malondialdehyde (MDA) and Superoxide dismutase by spectrophotometry
7
Description
plasminogen activator inhibitor-1
Timepoint
At the beginning and end of the study after 8 weeks
Method of measurement
Measurement with ELISA kit
Secondary outcomes
1
Description
Physical activity level
Timepoint
At the begening and end of the intervention
Method of measurement
Via IPAQ questionnaire
2
Description
Quality of life
Timepoint
At the beginning and end of the study after 8 weeks
Method of measurement
Via MacNew questionnaire
3
Description
depression severity
Timepoint
At the beginning and end of the study after 8 weeks
Method of measurement
Beck Depression Inventory scale
4
Description
blood pressure
Timepoint
At the beginning and end of the study after 8 weeks
Method of measurement
Using a mercury barometer
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
2
Description
Control group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Medical Research Training Center
Full name of responsible person
Dr mohammad alizadeh
Street address
Daneshgah street, Shahid Madani Medical Research Training Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
+98 41 3334 0634
Email
mdalizadeh@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Samiei
Street address
Vice Chancellor for Research No 2 Central Building, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Email
mdalizadeh@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Marzieh heidari
Position
Msc student of clinical nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golgasht street, Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3381 1902
Fax
+98 41 3334 0634
Email
Mheidari.95@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr mohammad alizadeh
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street, Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
Email
mdalizadeh@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr mohammad alizadeh
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street, Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 7313
Email
mdalizadeh@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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