Atherosclerotic Coronary Heart disease. Atherosclerotic heart disease
Conditions
Interventions
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-caps
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 fres
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) rece
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
for two weeks.
Sponsors
Vice Chancellor for research of Tarbiat Modares University, Faculty of medical science
Eligibility
Sex/Gender
Male
Age
45 Years to 55 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRahimi Parisa
Tarbiat Modares University
Outcome results
None listed