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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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History
# Registration date Revision Id
3 2021-06-09, 1400/03/19 186783
2 2021-02-21, 1399/12/03 174257
1 2021-02-19, 1399/12/01 171759
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  • Protocol summary

    Patients in the age range of 65-40 years 25
    Inclusion criteria: Patients in the age range of 65-40 years, 25
    بیماران در محدوده سنی 65-40 سال نمایه توده بدنی بین 35-25 اثبات تنگی50% در حداقل یکی از شریان های کرونری در آنژیوگرافی توانایی و تمایل در همکاری در طرح معیار های عدم ورود: مصرف دخانیات ، الکل و قلیان هیپوتیروئیدی و هیپر تیروئیدی دیابت کنترل نشده سابقه انفارکتوس میوکارد قلب اختلالات در عملکرد قلب(کلاس 3و4) بیماری دریچه ای قلبی نارسایی کلیوی زنان باردار و شیرده مصرف مکمل های گیاهی و آنتی اکسیدانی در سه ماه اخیر
    بیماران در محدوده سنی 65-40 سال، نمایه توده بدنی بین 35-25، اثبات تنگی50% در حداقل یکی از شریان های کرونری در آنژیوگرافی، توانایی و تمایل در همکاری در طرح معیار های عدم ورود: مصرف دخانیات ، الکل و قلیان، هیپوتیروئیدی و هیپر تیروئیدی، دیابت کنترل نشده، سابقه انفارکتوس میوکارد قلب، اختلالات در عملکرد قلب(کلاس 3و4)، بیماری دریچه ای قلبی، نارسایی کلیوی، زنان باردار و شیرده، مصرف مکمل های گیاهی و آنتی اکسیدانی در سه ماه اخیر
    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.
    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)
    گروه اول 12 میلی گرم در روز آستاگزانتین دریافت خواهند کرد و گروه دوم 12 میلی گرم در روز میکروکریستالین سلولز دریافت خواهند کرد. مدت مداخله دو ماه خواهد بود
    گروه اول 12 میلی گرم در روز آستاگزانتین دریافت خواهند کرد و گروه دوم 12 میلی گرم در روز میکروکریستالین سلولز دریافت خواهند کرد. مدت مداخله دو ماه خواهد بود. هر دو گروه رژیم غذایی کاهش وزن( کسر 500 کیلوکالری) درفات خواهند کرد

  • Primary outcomes

    #1
    empty
    Anthropometric Indices
    empty
    شاخص های تن سنجی
    empty
    Baseline and 8 weeks after intervention
    empty
    در ابتدا و 8 هفته پس از مداخله
    empty
    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
    empty
    اندازه گیری قد، وزن بدون کفش و با حداقل لباس ممکن، به ترتیب با استفاده از قدسنج و ترازوی Seca، اندازه گیری دور کمر و دور باسن با نوار متری و نمایه توده بدن (BMI) با استفاده از فرمول weight (kg)/height (m)2 و اندازه گیری ترکیب بدن

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Marzieh heidari
    Full name of responsible person - Persian: مرضیه حیدری
    Position - English: Msc student of clinical nutrition
    Position - Persian: دانشجو کارشناسی ارشد تغذیه بالینی
    Latest degree: bachelor
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Golgasht street, Tabriz university of medical sciences
    Street address - Persian: خیابان گلگشت، دانشگاه علوم پزشکی تبریز
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3381 1902
    Mobile: +98 939 737 2075
    Fax: +98 41 3334 0634
    Email: Mheidari@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Marzieh heidari
    Full name of responsible person - Persian: مرضیه حیدری
    Position - English: Msc student of clinical nutrition
    Position - Persian: دانشجو کارشناسی ارشد تغذیه بالینی
    Latest degree: bachelor
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Golgasht street, Tabriz university of medical sciences
    Street address - Persian: خیابان گلگشت، دانشگاه علوم پزشکی تبریز
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3381 1902
    Mobile: +98 939 737 2075
    Fax: +98 41 3334 0634
    Email: Mheidari.95@yahoo.com
    Web page address:

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: 2021-03-08, 1399/12/18
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 included, HDL-LDL-TG-TC
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 include FBS, insulin, HOMA-IR
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

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
En At the beginning and end of the study after 8 weeks
Method of measurement
Via MacNew questionnaire

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
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