Protocol summary
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Study aim
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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
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 44 patients. PASS software was used for randomization.
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Settings and conduct
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Eligible patients will be selected by a cardiologist and will be included in the study
Blinding will be done for researchers and patients.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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)
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Main outcome variables
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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
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2021-02-19, 1399/12/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-02-17, 1399/11/29
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Expected recruitment end date
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2021-08-21, 1400/05/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The effect of astaxanthin supplementation in patients with coronary artery disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 40 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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During the study, neither participants nor researchers will know that each person is in the intervention or control group.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-02-16, 1399/11/28
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Ethics committee reference number
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IR.TBZMED.REC.1399.1060
Health conditions studied
1
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Description of health condition studied
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Coronary Artery Disease
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Serum level of Sirtuin1
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Timepoint
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At the beginning and end of the study after 8 weeks
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Method of measurement
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Measurement with ELISA kit
2
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Description
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Serum level TNF-∝
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Timepoint
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At the beginning and end of the study after 8 weeks
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Method of measurement
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Measurement with ELISA kit
3
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Description
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Lipid profile
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Timepoint
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At the beginning and end of the study after 8 weeks
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Method of measurement
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Enzyme kits and the Friedwald equation
4
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Description
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Glycemic indexes
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Timepoint
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At the beginning and end of the study after 8 weeks
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Method of measurement
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ELISA and spectrophotometer
5
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Description
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Anthropometric Indices
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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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
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Description
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Oxidative stress indices
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Timepoint
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At the beginning and end of the study after 8 weeks
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Method of measurement
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Measurement of serum levels of Total antioxidant capacity (TAC) and malondialdehyde (MDA) and Superoxide dismutase by spectrophotometry
7
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Description
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plasminogen activator inhibitor-1
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Timepoint
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At the beginning and end of the study after 8 weeks
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Method of measurement
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Measurement with ELISA kit
Secondary outcomes
1
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Description
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Physical activity level
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Timepoint
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At the begening and end of the intervention
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Method of measurement
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Via IPAQ questionnaire
2
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Description
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Quality of life
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Timepoint
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At the beginning and end of the study after 8 weeks
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Method of measurement
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Via MacNew questionnaire
3
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Description
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depression severity
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Timepoint
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At the beginning and end of the study after 8 weeks
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Method of measurement
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Beck Depression Inventory scale
4
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Description
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blood pressure
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Timepoint
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At the beginning and end of the study after 8 weeks
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Method of measurement
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Using a mercury barometer
Intervention groups
1
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Description
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Intervention group:
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Category
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Treatment - Drugs
2
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Description
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Control group:
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available