4.1. Patients and Study Design
autoimmune or congenital heart disease, Hypertriglyceridemic
VASODILATION, RECRUITMENT, DYSTHYROIDISM, LIVER DISEASE
One hundred and five non-smoking consecutive male volunteers from the blood bank of the Instituto Nacional de Cardiologia “Ignacio Chavez” were screened for this study. Subjects with triglycerides plasma levels > 200 mg/dL, who were not taking any anti-dyslipidemic drug, and did not have dysthyroidism, liver disease, autoimmune or congenital heart disease as determined using biochemical analyses or medical history, were invited to the next step of the study. Volunteers completed a survey regarding lifestyle factors, medication, and diet habits, which included a 24 h questionnaire. Then, subjects were instructed to follow an isocaloric diet personally designed to reach a balanced intake of 50, 30, and 20% of total calories from carbohydrates, lipids, and proteins, respectively. Subjects whose fasting triglyceride plasma levels decreased below 200 mg/dL after one week of an isocaloric diet were excluded. Eighteen subjects were finally included to complete the trial. The Isocaloric diet was continued during the study (We performed a single-blind randomized crossover study that was placebo-controlled. Hypertriglyceridemic patients received EPA 460 mg and DHA 380 mg twice a day for 5 weeks or placebo, followed by a washout period of 4 weeks before crossover. Anthropometric measures, blood pressure, flow-mediated vasodilation, biochemical profile and HDL characterization were performed before and after placebo or EPA + DHA supplementation.The study was performed in accordance with the appropriate version of the Declaration of Helsinki and approved by the Ethics Committee from the Instituto Nacional de Cardiología “Ignacio Chávez” with registration numbers 17-996 and 22-1338. All the patients gave their written informed consent prior to the recruitment.