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The effects of Na- selenite and Na- selenite -enriched yeast supplementation on glycemic status, lipid profile, oxidative and nitrosative stress in patients with coronary artery diseases.

Protocol summary

Study aim
The effects of Na- selenite and Na- selenite -enriched yeast supplementation on glycemic status, lipid profile, oxidative and nitrosative stress in patients with coronary artery diseases
Design
A clinical trial with a placebo group with parallel, double-blind and Phase 2 randomization based on a table of random sequences on 45 patients
Settings and conduct
َA double-blind randomized clinical trial study (blinding of patients and investigators) Setting: Shahid madani heart hospital
Participants/Inclusion and exclusion criteria
inclusion criteria: Participants with age range 30-65 years old, Diagnosis of atherosclerosis, Not taking any antioxidant and anti-inflammatory supplements, Overweight and obese patients, Exclusion criteria: Malignancies, autoimmune, and infectious diseases. Blood disease. Chronic diseases, such as liver, kidney, and thyroid diseases. Pregnancy and lactation. Exposure to any side effects during the study. Consumers of antacids, antibiotics, alcohol and cigarette
Intervention groups
In this project, 45 people with coronary artery disease who refer to the Shahid Madani Hospital in Tabriz, Iran will be selected based on inclusion and exclusion criteria. These patients are randomly divided into three groups of 15 people. The study groups will receive a yeast-enriched yeast capsule with sodium selenite, sodium selenite, or placebo for eight weeks at a daily dose of 200 micrograms before the meal.
Main outcome variables
Sodium selenium-enriched yeast supplements compared to sodium selenium and placebo supplementation will be more effective on glycemic status; lipid profile; oxidative and nitrosative stress in patients with coronary artery diseases

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110123005670N28
Registration date: 2020-07-20, 1399/04/30
Registration timing: retrospective

Last update: 2020-07-20, 1399/04/30
Update count: 0
Registration date
2020-07-20, 1399/04/30
Registrant information
Name
Ali Tarighat-Esfanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 300 5895
Email address
tarighata@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-02, 1398/03/12
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
2019-06-02, 1398/03/12
Actual recruitment end date
2019-10-22, 1398/07/30
Trial completion date
2020-03-20, 1399/01/01
Scientific title
The effects of Na- selenite and Na- selenite -enriched yeast supplementation on glycemic status, lipid profile, oxidative and nitrosative stress in patients with coronary artery diseases.
Public title
Effects of Na- selenite in Patients with Coronary Artery Diseases
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study and sign informed consent form after full knowledge of the purpose and method of the study Men and women with 30-65 years age range Diagnosis of atherosclerosis by a physician based on angiography results with at least 50% vascular obstruction in at least one vessel Not using any antioxidant and anti-inflammatory supplements for at least 1 month before starting the study Patients with overweight and obesity (BMI = 25 - 35 Kg / m²)
Exclusion criteria:
A variety of malignancies, autoimmune and infectious diseases Chronic diseases such as liver, kidney and thyroid diseases Pregnancy and lactation Exposure to any side effects during the study Consumers of antacids, antibiotics, alcohol and cigarette users Blood disease and osteoporosis allergies
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The study is divided into three groups using simple randomization method with allocation ratio 1:1 via random allocation sequence
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be conducted in a double-blind manner, meaning that the researchers and patients are not aware of the three groups of interventions.
Placebo
Used
Assignment
Parallel
Other design features
The study aimed to evaluate the effect of Na- selenite and Na- selenite -enriched yeast supplementation on glycemic status, lipid profile, oxidative and nitrosative stress in patients with coronary artery diseases. It is hoped that these supplements can be used to improve and treat cardiovascular disease alongside other prevalent treatments.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Faculty of nutrition science, east azarbayjan province, Tabriz University of Medical sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
IR.TBZMED.REC.1398.1187

Health conditions studied

1

Description of health condition studied
Coronary artery disease
ICD-10 code
I25.11
ICD-10 code description
Atherosclerotic heart disease of native coronary artery with angina pectoris

Primary outcomes

1

Description
glutathione peroxidase level
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
Biochemical

2

Description
nitric oxide.
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
biochemical

3

Description
malondialdehyde level
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
biochemical

4

Description
triglyceride
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
biochemical

5

Description
HDL- cholestrol
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
biochemical

6

Description
LDL-cholestrol
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
biochemical

7

Description
total cholestrol
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
biochemical

8

Description
fasting blood glucose
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
biochemical

9

Description
fasting insulin
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
biochemical

10

Description
hemoglobin A1c
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
biochemical

11

Description
superoxide dismotase
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
biochemical

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: The first intervention group will receive sodium selenite-enriched yeast capsule at a dose of 200 μg for 8 weeks. Yeast supplement enriched with sodium selenite has been prepared in collaboration with the Nutrition Research Center and Faculty of Pharmacy, Tabriz University of Medical Sciences.
Category
Other

2

Description
Intervention group: The second intervention group will receive sodium selenite capsule at a dose of 200 micrograms for 8 weeks .Sodium selenite supplement has been prepared in collaboration with Nutrition Research Center and Tabriz University of Medical Sciences.
Category
Other

3

Description
Control group: The third group will receive placebo at a dose of 200 μg for 8 weeks . The placebo (starch capsules) have been prepared in collaboration with the Nutrition Research Center and Faculty of Pharmacy, Tabriz University of Medical Sciences.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani heart hospital
Full name of responsible person
Neda Roshanravan
Street address
Shahid Madani heart hospital, Daneshgah street, Tabriz, Iran
City
tabriz
Province
East Azarbaijan
Postal code
5166615573
Phone
+98 41 3335 7767
Email
neda.roshanravan10@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Tarighat Esfanjani
Street address
Tabriz University of Medical Science, Faculty of Nutrition, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 5921
Fax
Email
tarighata@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
Ali Tarighat Esfanjani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Science, Faculty of Nutrition, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 5921
Email
tarighat45@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Tarighat Esfanjani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Science, Faculty of Nutrition, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 5921
Email
tarighata@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Tarighat Esfanjani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Science, Faculty of Nutrition, Golgasht Street, Tabriz, Iran
City
tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 5921
Email
tarighat45@gmail.com

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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