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IRCT2017092836469N1 IRCT 2017-11-20 Vice Chancellor for research of Tarbiat Modares University, Faculty of medical science supplementation in coronary heart disease CVD CHD Investigation of the effect of two weeks supplementation with red Beet root and Prickly pear aqueous extract powder on the plasma Sirtuin 1 and homocysteine concentrations, SIRT-1 and LOX-1 gene expressions, and lipids profile in overweight and obese male patients with Coronary Heart Disease. 2017-11-01 anticipated 24 Complete https://irct.ir/trial/27251 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Prevention, Randomization description: Patients are classified into two groups by random block method. A random sequence is generated using the STATA14 software, Blinding description: In this study, all relevant people (participants, care provider, outcome assessor, data analyzer, and data safety and monitoring board) except the investigator, are blind using the coding system before starting intervention. Researchers who involved in the writing of paper and final conclusion would have permission to access decoded information in order to have the best interpretations and scientific results. N/A Atherosclerotic Coronary Heart disease. Intervention 1: Part1: Consumption of a single dose of 50 mg of betacyanins and of betaxanthins (purified from red beetroot extract) by patients. Part2: The first group (n=24) receive one 500mg-capsule of betalains-rich extract of red beetroot (the freeze-dried powders containing 5% betalain, prepared from fresh red beetroot juice. This powder is containing 25 mg betalain, a little sugar, protein and depleted of fiber) two times daily; for 2 weeks, followed by two weeks wash out. After that, they receive one 500mg-capsule of betacyanins-rich extract of prickly pear (the freeze-dried powders containing 5% betalain, prepared from fresh red-purple Opuntia stricta fruit. This powder is containing 25 mg betacyanins, a little sugar, protein and depleted of fiber) two times daily; for 2 weeks, followed by two weeks wash out. After that, they receive one placebo capsules, two times daily; for two weeks. Intervention 2: Part 1: Consumption of a single dose of 50 mg of betacyanins and of betaxanthins (purified from red beetroot extract) by patients Part 2: The first group (n=24) receive one 500mg-capsule of betacyanins-rich extract of prickly pear (the freeze-dried powders containing 5% betalain, prepared from fresh red-purple Opuntia stricta fruit. This powder is containing 25 mg betacyanins, a little sugar, protein and depleted of fiber) two times daily; for 2 weeks, followed by two weeks wash out. After that, they receive one 500mg-capsule of betalains-rich extract of red beetroot (the freeze-dried powders containing 5% betalain, prepared from fresh red beetroot juice. This powder is containing 25 mg betalain, a little sugar, protein and depleted of fiber) two times daily; for 2 weeks, followed by two weeks wash out. After that, they receive one placebo capsules, two times daily; for two weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Rahimi Parisa
Tehran- Jalal AleAhmad- Nasr
Tehran Iran (Islamic Republic of) 217777777 +98 21 8288 0000 parisa.rahimi@modares.ac.ir Tarbiat Modares University scientific Mesbah-Namin Seyed Alireza
Tehran- Jalal AleAhmad- Nasr
Tehran Iran (Islamic Republic of) 11415-111 +98 21 8288 3570 mesbahna@modares.ac.ir Tarbiat Modares university Iran (Islamic Republic of) Men Diagnosed with Coronary heart patients 45-55 y of old BMI (in kg/m2) of 25-35 No tobacco or alcohol consumption free of any serious and life-threatening illness, Malignancy, Cancer, Diabetes, Autoimmune disease, Infectious diseases, Anemia and with no stone maker kidney or bladder Subjects with no history of allergic reaction to beetroot or prickly pear No changes in drug administration (patients only consume typically administered drugs for hypertension or dyslipidemia) Subjects with no recent or current consumption of interventional supplements Patients will be enrolled following an informed consent. 45 years 55 years Male Myocardial Infarction Strenuous exercise Fasting Allergic reactions Any exposure or catch of infectious disease Any side effect Subjects with recent or current taking systemic medication (other than the usual drug for hypertension and dyslipidemia) Patients with Failure to execute commands Healthy subjects unwilling to consent I25.1 Atherosclerotic heart disease Treatment - Other Treatment - Other Part1: Consumption of a single dose of 50 mg of betacyanins and of betaxanthins (purified from red beetroot extract) by patients. Part2: The first group (n=24) receive one 500mg-capsule of betalains-rich extract of red beetroot (the freeze-dried powders containing 5% betalain, prepared from fresh red beetroot juice. This powder is containing 25 mg betalain, a little sugar, protein and depleted of fiber) two times daily; for 2 weeks, followed by two weeks wash out. After that, they receive one 500mg-capsule of betacyanins-rich extract of prickly pear (the freeze-dried powders containing 5% betalain, prepared from fresh red-purple Opuntia stricta fruit. This powder is containing 25 mg betacyanins, a little sugar, protein and depleted of fiber) two times daily; for 2 weeks, followed by two weeks wash out. After that, they receive one placebo capsules, two times daily; for two weeks. Part 1: Consumption of a single dose of 50 mg of betacyanins and of betaxanthins (purified from red beetroot extract) by patients Part 2: The first group (n=24) receive one 500mg-capsule of betacyanins-rich extract of prickly pear (the freeze-dried powders containing 5% betalain, prepared from fresh red-purple Opuntia stricta fruit. This powder is containing 25 mg betacyanins, a little sugar, protein and depleted of fiber) two times daily; for 2 weeks, followed by two weeks wash out. After that, they receive one 500mg-capsule of betalains-rich extract of red beetroot (the freeze-dried powders containing 5% betalain, prepared from fresh red beetroot juice. This powder is containing 25 mg betalain, a little sugar, protein and depleted of fiber) two times daily; for 2 weeks, followed by two weeks wash out. After that, they receive one placebo capsules, two times daily; for two weeks. Sirtuin-1 gene. Timepoint: days: 0, 14, 28, 42, 56, 70, and after single dose consumption in part 2 of study. Method of measurement: expression measurement with Real-Time PCR. Lectin-like oxidized low density lipoprotein receptor-1 gene. Timepoint: days: 0, 14, 28, 42, 56, 70, and after single dose consumption in part 2 of study. Method of measurement: expression measurement with Real-Time PCR. Sirtuin-1 protein. Timepoint: days: 0, 14, 28, 42, 56, 70, and after single dose consumption in part 2 of study. Method of measurement: Concentration measurement with ELIZA. Fasting Blood Glucose. Timepoint: days: 0, 14, 28, 42, 56, 70. Method of measurement: spectrophotometric assay and autoanalyzer. Blood pressure. Timepoint: days: 0, 14, 28, 42, 56, 70, and after single dose consumption in part 2 of study. Method of measurement: digital blood pressure monitor. Homocystein. Timepoint: days: 0, 14, 28, 42, 56, 70. Method of measurement: Concentration measurement with ELIZA. Lipid profile. Timepoint: days: 0, 14, 28, 42, 56, 70. Method of measurement: Concentration measurement with Enzyme, Autoanalyzer and formula. C-reactive protein. Timepoint: days: 0, 14, 28, 42, 56, 70. Method of measurement: Concentration measurement with ELIZA. Health related quality of life. Timepoint: days: 0, 14, 28, 42, 56, 70. Method of measurement: MacNew questionnaire. Hulbert Index of Sexual Desire (HISD). Timepoint: days: 0, 14, 28, 42, 56, 70. Method of measurement: questionnaire. Dietary intake and appetite assessment. Timepoint: weekly. Method of measurement: questionnaire. Beck Depression Inventory II (BDI-II). Timepoint: days: 0, 14, 28, 42, 56, 70. Method of measurement: questionnaire. Plasma and urine profile of betalains. Timepoint: days: 0, 14, 28, 42, 56, 70, and after single dose consumption in part 2 of study. Method of measurement: High-performance liquid chromatography–tandem mass spectrometry (HPLC–MS/MS). Vice Chancellor for research of Tarbiat Modares University, Faculty of medical science Approved 2017-09-23 Ethics committee of Tarbiat Modares University Tehran, Jalal AleAhmad , Nasr Tehran Tehran Iran (Islamic Republic of)