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IRCT20210217050393N1 IRCT 2021-05-16 Mashhad University of Medical Sciences Evaluation of the effect of red beet in patients with chronic coronary heart disease Evaluation of the effect of red beetroot tablet alone or in combination with vitamin C on cardiovascular function in patients with chronic coronary heart disease. Double blind Randomized clinical trial. 2021-04-21 anticipated 90 Complete https://irct.ir/trial/55234 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To apply randomization, the permuted block randomization method with quadruple blocks will be used. According to the sample size of 90 that has been determined, 18 blocks of 5 will be produced using the online site (www.sealedenvelope.com). In order to apply concealment in the randomization process, unique codes will be used on the medicine boxes, and the desired code will also be generated by the online site. Concealed allocation is done using opaque envelopes, in packages, sealed and sequentially, Blinding description: In order to apply blinding in the randomization process, unique codes will be used on the medicine boxes, and the desired code will also be produced by the online site. In the present study, participants, principle investigator , healthcare providers, outcome assessors will be blinded. 3 coronary heart disease. Intervention 1: Intervention group 1: Three 1000 mg tablets of concentrated red beet daily (containing 22 mg of nitrate as active ingredient and other compounds including betalines, carotenoids, phenolic acids and flavonoids, which in the initial phase of the present project were Prepared beetroot powder with freeze drier method and produced in the form of tablets), will intervene for 6 weeks. Intervention 2: Intervention group 2: Three 1000 mg contain beetroot and 100 mg vitamin C tablets daily for 6 weeks. Intervention 3: Control group: Three 1000 mg placebo tablets (Starch with edible color of red beets) daily for 6 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Reza Rezvani
Mashhad university of medical sciences, Azadi squre
Mashhad Iran (Islamic Republic of) 99191-91778 +98 51 3841 2081 rezvanir@mums.ac.ir Mashhad University of Medical Sciences scientific Reza Rezvani
Mashhad university of medical sciences, Azadi squre
Mashhad Iran (Islamic Republic of) 99191-91778 +98 51 3841 2081 rezvanir@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age 30 to 65 years male and female with chronic coronary artery disease Willingness to participate in research 30 years 65 years Both Body Mass Index more than 30 kg / m2 Disease (diabetes, kidney stones, gallstones, cancer and other chronic diseases) Acute heart accident in the past year Taking any medicine outside the treatment protocol 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) Consumption of any herbal medicines Allergy to red beet Pregnancy and breastfeeding Smoking and drugs Alcohol consumption Nitrate-containing drugs (such as nitroglycerin, isosorbide) The occurrence of any accident that affects a person's health Having any acute illness during the study Reluctance to continue cooperation in research Do not take more than 10% of tablets I25.1 Atherosclerotic heart disease of native coronary artery Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Three 1000 mg tablets of concentrated red beet daily (containing 22 mg of nitrate as active ingredient and other compounds including betalines, carotenoids, phenolic acids and flavonoids, which in the initial phase of the present project were Prepared beetroot powder with freeze drier method and produced in the form of tablets), will intervene for 6 weeks Intervention group 2: Three 1000 mg contain beetroot and 100 mg vitamin C tablets daily for 6 weeks Control group: Three 1000 mg placebo tablets (Starch with edible color of red beets) daily for 6 weeks Pulse Wave Velocity. Timepoint: before and after intervention. Method of measurement: with pulse velocimetry. Augmentation index. Timepoint: before and after intervention. Method of measurement: with pulse velocimetry. Flow mediate dilation. Timepoint: before and after intervention. Method of measurement: with pulse velocimetry. VO2max. Timepoint: before and after intervention. Method of measurement: CPET device. Lipid profile. Timepoint: before and after intervention. Method of measurement: blood test. Interleukin 6. Timepoint: before and after intervention. Method of measurement: blood test. High sensitive-C Reactive Protein. Timepoint: before and after intervention. Method of measurement: blood test. Intercellular-adhesion molecule (I-CAM). Timepoint: before and after intervention. Method of measurement: blood test. Vascular cell adhesion molecule (VCAM). Timepoint: before and after intervention. Method of measurement: blood test. Systolic blood pressure. Timepoint: before and after intervention. Method of measurement: Sphygmomanometer. Diastolic blood pressure. Timepoint: before and after intervention. Method of measurement: Sphygmomanometer. Weight. Timepoint: before and after intervention. Method of measurement: digital scale. Waist circumference. Timepoint: Before and after the intervention. Method of measurement: Non-elastic meters. Neck circumference. Timepoint: Before and after the intervention. Method of measurement: Non-elastic meters. Waist to hip ratio. Timepoint: Before and after the intervention. Method of measurement: Waist to hip ratio. Body Shape Index. Timepoint: Before and after the intervention. Method of measurement: waist circumference/ body mass index 2/3* height 1/2. Body mass index. Timepoint: Before and after the intervention. Method of measurement: weight/(height)2. Quality of life and health. Timepoint: Before and after the intervention. Method of measurement: SF36 questionnaire. Mashhad University of Medical Sciences Approved 2020-09-22 Ethics committee of Mashhad university of medical sciences Mashhad university of medical sciences, Azadi squre Mashhad Razavi Khorasan Iran (Islamic Republic of)