Evaluation of the effect of supplementation beetroot capsul with or without vitamin C on oxidative stress factors in patients with chronic coronary heart disease. Double blind Randomized trial
Effect of supplementation beetroot capsul with vitamin C on oxidative stress factors in patients with chronic coronary heart disease
Design
This is a double-blind randomized clinical trial study performed on 90 men and women aged 30 to 65 years with coronary heart disease. Two intervention groups and one control group are parallel. Phase 3 on 90 patients. To apply randomization, the permuted block randomization method with quadruple blocks will be used.23 blocks of 4 will be produced using the online site (www.sealedenvelope.com).
Settings and conduct
Imam Reza Hospital Candidates are randomly divided into 3 groups receiving medication and placebo. At the beginning of the study, 10 ml of venous blood sample is taken from each person in the fasting state.Concealed allocation using opaque envelopes, in closed, sealed and sequential (double-blind random)
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Age 30 to 65 years 2. Men and women with chronic coronary artery disease 3. Willingness to participate in research
Exclusion criteria: 1. Do not consume more than 10% of capsules 2. The occurrence of any accident that affects a person's health 3. Having any acute illness during the study 4. Reluctance to continue cooperation in research
Intervention groups
Two groups of drug recipients: 1. 30 men and women with coronary heart disease, each for 4 weeks, will receive three capsules of 500 mg of red beet daily 2. 30 men and women with coronary heart disease The coronary arteries will each receive three 500 mg beetroot and vitamin C capsules daily for 4 weeks. Placebo group: 30 men and women with coronary heart disease will receive three placebo capsules daily for 4 weeks, which are very similar in appearance and volume to the drug capsule.
Evaluation of the effect of supplementation beetroot capsul with or without vitamin C on oxidative stress factors in patients with chronic coronary heart disease. Double blind Randomized trial
Public title
Evaluation of the effect of supplementation beetroot capsul with or without vitamin C on oxidative stress factors in patients with chronic coronary heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age 30 to 65 years
2. Men and women with chronic coronary artery disease
3. Willingness to participate in research
Exclusion criteria:
1. Do not consume more than 10% of capsules
2. The occurrence of any accident that affects a person's health
3. Having any acute illness during the study
4. Reluctance to continue cooperation in research
5. Body Mass Index more than 30 kg / m2
6. Acute heart accident in the past year
7.Taking any medicine outside the treatment protocol
8. Consumption of any herbal medicines
9. Allergy to red beet
10. Nitrate-containing drugs (such as nitroglycerin, isosorbide)
11. Using oral and injectable nutritional supplements for at least the last 4 months (vitamins D, C, E, calcium, magnesium, potassium and multivitamin-mineral, omega 3)
12. Disease (diabetes, kidney stones, gallstones, cancer and other chronic diseases)
Age
From 35 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
2
10 ml venous blood sample / Anthropometric variables
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization
To apply randomization, the method of permuted block randomization with quadruple blocks will be used. In order to apply concealment in the randomization process, unique codes will be used on drug boxes, and the desired code will also be used by the online site. it is produced.
Concealed allocation using opaque envelopes, in closed, sealed and sequential
Blinding (investigator's opinion)
Double blinded
Blinding description
Concealed allocation using opaque envelopes, in closed, sealed and sequential.
Participants (lack of knowledge of intervention groups), Care providers (lack of knowledge of sample type assignment to groups), Investigator
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Khorasan Razavi, Mashhad, East door of Ferdowsi University, faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2022-05-31, 1401/03/10
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.157
Health conditions studied
1
Description of health condition studied
Coronary heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Malondialdehyde
Timepoint
At the beginning of the study and 28 days after consume red beet capsules
Method of measurement
laboratory kit
2
Description
Myeloperoxidase
Timepoint
At the beginning of the study and 28 days after consume red beet capsules
Method of measurement
laboratory kit
3
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and 28 days after consume red beet capsules
Method of measurement
laboratory kit
4
Description
Total Oxidant Status
Timepoint
At the beginning of the study and 28 days after consume red beet capsules
Method of measurement
laboratory kit
Secondary outcomes
1
Description
Waist circumference
Timepoint
At the beginning of the study and 28 days after the intervention
Method of measurement
tape measure
2
Description
Hip circumference
Timepoint
At the beginning of the study and 28 days after the intervention
Method of measurement
tape measure
3
Description
Neck circumference
Timepoint
At the beginning of the study and 28 days after the intervention
Method of measurement
tape measure
4
Description
Weight
Timepoint
At the beginning of the study and 28 days after the intervention
Method of measurement
Bioelectrical Impedance Analysis(BIA)
5
Description
Fat mass
Timepoint
At the beginning of the study and 28 days after the intervention
Method of measurement
Bioelectrical Impedance Analysis(BIA)
6
Description
Free fat mass
Timepoint
At the beginning of the study and 28 days after the intervention
Method of measurement
Bioelectrical Impedance Analysis(BIA)
7
Description
Body Mass Index(BMI)
Timepoint
At the beginning of the study and 28 days after the intervention
Method of measurement
Bioelectrical Impedance Analysis(BIA)
Intervention groups
1
Description
Intervention group1: 30 men and women with coronary heart disease received three 500 mg red beet capsules daily for 4 weeks each.
Category
Treatment - Drugs
2
Description
Intervention group 2 : 30 men and women with coronary heart disease received three 500 mg capsules of red beets and vitamin C daily for 4 weeks each.
Category
Treatment - Drugs
3
Description
Control group: Control group: 30 men and women with coronary heart disease received three placebo capsules a day for 4 weeks each, which is very similar in appearance and volume to the drug capsule.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Reza Rezvani
Street address
Imam Reza Square - Ibn Sina St. - Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9191-991778
Phone
+98 51 3841 2081
Email
rezvanir@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Mashhad university of medical sciences, Azadi squre
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mashhad university of medical sciences, Azadi squre
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3841 2081
Email
rezvanir@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mashhad university of medical sciences, Azadi squre
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3841 2081
Email
rezvanir@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mashhad university of medical sciences, Azadi squre
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3841 2081
Email
rezvanir@mums.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