Effect of antioxidants suplementation in autonomic balance

Abstract

High level of antioxidants studies have been done and the results show a significant reduction in blood pressure and risk of cardiovascular events. The proposal of this study is to evaluate the effect of antioxidant supplementation in autonomic balance with normotensive and hypertensive patients. A randomized clinical trial will be conducted. After selection, 60 eligible individuals will be invited to participate in the study, 30 normotensive and 30 hypertensive patients. Participants must be of both gender, aged between 18 and 60 years and body mass index (BMI) less than 35 kg/m2. Exclusion criteria were as follows: pregnant women; smokers; diabetic patients using other medication for glycemic control different from metformin; with glycated hemoglobin <7%; diagnosed with cardiovascular disease; LDL-C> 160 mg / dl (non-diabetic); with LDL-C> 130 mg / dL for diabetics not on statins; with LDL-C e 100 mg / dL for diabetics on statins; with severe valvular heart disease; with pulmonary hypertension; carriers of collagen vascular disease; with some form of cancer; with complex arrhythmia; with any chronic debilitating disease. Venous blood samples will be collected after fasting for 12 hours for assay of biochemical (glucose, total cholesterol and fractions LDL-cholesterol, HDL-cholesterol, triglycerides, uric acid, sodium, potassium, urea, creatinine, insulin), blood count, adiponectin , leptin, C-reactive protein, tumor necrosis factor (TNF-±), interleukin 6 (IL-6), interleukin 4 (IL-4), interleukin-2 beta (IL-2SS) monocyte chemoattractant protein-1 (MCP-1 ) and nitrotyrosine. A pilot study was conducted to assess the antioxidant and total phenolic contents of the capsules of the fruit extracts capacity, demonstrating a large presence of antioxidant compounds. An anthropometric assessment with measures of weight, height, waist circumference and neck circumference will be held. Hemodynamic evaluation will be through a device (HDI) for noninvasive hemodynamic assessment and autonomic balance will also be assessed noninvasively with the aid of the pressure Finometer monitor. Study participants will be allocated to two different groups: Group A (normotensive) and Group B (hypertensive). They are randomized to supplements in capsule antioxidants or capsules placebo for 4 weeks. The capsules for antioxidant supplementation will be blueberry, cranberry and pomegranate, one capsule each a day. After an interval of 4 weeks, the group that had received supplementation receive placebo group receives placebo and antioxidant supplementation (crossover), both 4 weeks. All tests will be performed at baseline, after 4 weeks of intervention and after 8 weeks of intervention. The sample size calculation was done to achieve a statistical power of 80% and the number of cases required in each group is 27 individuals. The comparison between groups will be held with the Multiple Comparison Test (ANOVA). Before starting data collection, the research project will include the approval of the Ethics Committee for Analysis of Research Projects (CAPPesq), Hospital das Clinicas, Faculty of Medicine, University of São Paulo. The participation of the research will be voluntary, with signature of IC after the clarification of the nature and purpose of the study. This study will present minimal physical risk to the participant. (AU)