Protocol summary
-
Study aim
-
Effect of supplementation beetroot capsul with vitamin C on serum fatty acids and 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, 4 weeks intervention, three 500 mg capsules of red beet daily 2- 30 men and women with coronary heart disease, 4 weeks intervention , three 500 mg capsules of red beetroot and vitamin C daily. Placebo group: 30 men and women with coronary heart disease, 4 weeks intervention, three placebo capsules daily.
-
Main outcome variables
-
Saturated fatty acids (SFAs), Unsaturated fatty acids (UFAs), Total antioxidant capacity (TAC), Total oxidative status (TOS), malondialdehyde (MDA), myeloperoxidase (MPO)
General information
-
Reason for update
-
The addition of primary outcome and new factors in the analysis of blood samples
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20210217050393N3
Registration date:
2022-07-28, 1401/05/06
Registration timing:
prospective
Last update:
2023-07-27, 1402/05/05
Update count:
1
-
Registration date
-
2022-07-28, 1401/05/06
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2022-08-23, 1401/06/01
-
Expected recruitment end date
-
2022-12-22, 1401/10/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Effect of supplementation beetroot capsul with or without vitamin C on serum fatty acids and oxidative stress factors in patients with chronic coronary heart disease. Double blind Randomized trial
-
Public title
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
5
-
Description
-
Saturated fatty acids
-
Timepoint
-
At the beginning of the study and 28 days after consume red beet
-
Method of measurement
-
Gas Chromatography
6
-
Description
-
Polyunsaturated fatty acids
-
Timepoint
-
At the beginning of the study and 28 days after consume red beet
-
Method of measurement
-
Gas Chromatography
7
-
Description
-
Monounsaturated fatty acids
-
Timepoint
-
At the beginning of the study and 28 days after consume red beet
-
Method of measurement
-
Gas Chromatography
8
-
Description
-
Fatty acid indices
-
Timepoint
-
At the beginning of the study and 28 days after consume red beet
-
Method of measurement
-
Calculation through other fatty acids
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
1
-
Sponsor
-
-
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
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
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available