Carmel Biosciences, Inc.

Though medical treatment has been effective in the treatment of cardiometabolic diseases (including coronary atherosclerosis and diabetes mellitus), the incidence of these disorders continues to be high. Many reasons are responsible, but lifestyle changes, including an increased prevalence of obesity and the metabolic syndrome, are significant for this cause. Diagnosis and treatment of obese patients with hypertension requires that health care providers address the issues of hypertension, glucose intolerance, body weight and dyslipidemia. A sedentary lifestyle and poor cardiorespiratory fitness are not only associated with the (cardio) metabolic syndrome but could actually be considered features of the metabolic syndrome. These issues are significant in the health of certain individuals, who experience greater difficulty in treated BP control, experience increased hypertensive and diabetic complications, and have higher levels of obesity.
In this study, the investigators will evaluate the efficacy of the nutritional supplements berberine, alpha-lipoic acid, and picrorhiza (CAR-191) when consumed 30 minutes before meals, on appetite suppression, body composition and weight control. Additionally, the investigators will evaluate the effects of this combination of nutraceuticals on the mechanistic effects of oxidation, inflammation, and vascular function in a high-risk population with the metabolic syndrome.
Primary Objective To assess the comparative effect of a combination (known as CAR-191) of berberine (200 mg), alpha-lipoic acid (150 mg), and picrorhiza (100 mg) three times a day, compared to placebo three times a day, on parameters relate to appetite suppression, weight control and body composition in a high risk population with the metabolic syndrome.
Secondary Co-objectives
To evaluate the effects of CAR-191 versus placebo on changes in:
Endothelial function using noninvasive brachial artery reactivity (BAR) ultrasound
Biomarkers including IL-6, HOMA-IR, HbA1C, hsCRP, adiponectin, plasma/urine isoprostanes, PAI-1, TNFα-II, aldosterone, and glutathione redox ratio
Urinary protein excretion
Clinical chemistry including plasma glucose, blood urea nitrogen, creatinine, total bilirubin, uric acid, transaminases (SGOT/AST, SGPT/ALT), alkaline phosphatase, C-reactive protein, and lipoproteins