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.

The purposes of this study is to investigate the effects of consumption of two edible sources of betalain (red beetroot and prickly pear) on LOX1 and SIRT1 gene and protein expression and some of the atherosclerotic risk factors in patients with coronary heart disease (CHD).

double-blinded crossover randomized clinical trial

Participants were recruited from cardiologist referrals from Tabriz Shahid Madani medical research training Center. Other parts of this study is carried out at Tabriz University of Medical Sciences and Tarbiat Modares University. In this study, all relevant people except the investigator are blind to the study groups.

obese or overweight male patients (50 ± 5 y; BMI = 30± 5 kg/m2) with coronary heart disease

Part 1: Consumption of a single dose of 50 mg of betacyanins and of betaxanthins (purified from red beetroot extract) by same 48 patients Part 2: At first, patients will randomly be allocated to 2 study arms where each arm will consist of a sequence of three treatments given consecutively. The first group will receive capsules of red beetroot (contained 25 mg betalain) for two weeks, followed by two weeks wash out, and after that, for two weeks they received capsules of Opuntia stricta (contained 25 mg betacyanin ), followed by two weeks wash out and finally, for two weeks they received placebo capsule, and vice versa in the second group. Participants of both groups will be requested to take 1 capsules two times daily.

Measurement of Sirtuin-1 and Lectin-like oxidized low-density lipoprotein receptor 1 genes expression, and plasma levels of Sirtuin-1 protein are primary outcomes and blood pressure and fasting blood glucose, lipid profile, C-reactive protein, and homocysteine betalain profile of blood and urine are the secondary outcomes.

Tarbiat Modares University Tabriz University of Medical Science

Patients are classified into two groups by random block method. A random sequence is generated using the STATA14 software.

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.