Efeito de suplemento dietético à base de fitosterol associado à Dieta Passo II do NCEP sobre o LDL em crianças e adolescentes dislipidêmicos: Ensaio clínico randomizado cruzado, duplo cego.

Abstract

Even with the evidence of lipid-lowering effect of plant sterols among dyslipidemic adults, the use of capsules with phytosterols in children is limited. The objective of the present study was evaluate the effect of phytosterol-based dietary supplementation associated with the Step II diet NCEP, in LDL of dyslipidemic children and adolescents at university hospital in Rio de Janeiro. A randomized, double-blind, crossover clinical trial with placebo was realized for 20 weeks. Thirty-one children and adolescents between seven and fourteen years old participated in the study. The intervention group received capsules containing 1.5g / day of phytosterols in the free and esterified form and the control group received capsules containing 2g / day of sunflower oil during the eight-week period. The partitipants were submited to wash out during four weeks. Biochemical data were collected including glucose, total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL) and triglycerides; anthropometric measures at weeks 0, 8, 12 and 20. Intention-to-treat analysis were performed, using the proc mixed procedure in SAS. In the end of run in 9 participats reduced LDL above 110mg/dL, representing 25% sample size. The prevalence of obesity was also observed in 66.7% of the participants who reduced LDL in the run-in. Intention-to-treat analysis were performed, using the proc mixed procedure in SAS. After eight weeks, participants in the intervention group reduced LDL by 6.48%, while the control group had a reduction of 1.68%. HDL increased by 15.2% in the intervention group and 0.07% in the control group. 35% of participants in the intervention group achieved values considered desirable for LDL. However, none of these variations was significantly different between groups. Even the study did not achieve significantly statistic diference on reduction of LDL between the groups, the intake of phytosterol´s capsule showed safe on dislipidemic in child and youth treatment. It is also noted that the step II diet of the NCEP proved to be effective in reducing LDL in obese children and adolescents, which is a revealing result for reducing cardiovascular risk.The results presented in the present study reinforce the need for new studies involving supplementation of phytosterol with capsules, so that they can be compared.