DIETARY INTERVENTION IN CHILDREN WITH ELEVATED LDL-C

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The purpose of this study is to test the efficacy, feasibility and safety of dietary intervention in pre-adolescent children with elevated LDL-cholesterol (LDL-C) levels. Participants recruited from referrals from a large network of pediatricians and cardiologists will be randomly assigned to either the usual or special care group to evaluate LDL-C response to non-pharmacologic nutritional intervention. Based on the recommendations of the American Heart Association and the NIH Consensus Panel, participants will be guided toward maximum reduction in total fat, saturated fat and dietary cholesterol with compensatory increases in complex carbohydrate and water soluble fiber. The eating pattern will emphasize fruits, vegetables, whole grains, low fat dairy products and lean animal protein sources. Sodium reduction will be encouraged. In addition, participants will be advised to perform regular aerobic activity and to achieve ideal weight for height. Nutritional status will be carefully monitored through biochemical, anthropometric and dietary assessments, to promote normal growth and development and to achieve optimal intake of essential nutrients. Psychosocial development will also be evaluated and strategies for coping with peer pressure and other obstacles to optimal nutrition in a relatively unsupportive modern society will be presented. Changes in LDL-C levels will be compared between the two groups from baseline to the end of the study to evaluate the effectiveness of intervention. These findings will help to determine whether children will have a sufficient clinical response to reduce their percentile rank on the plasma cholesterol distribution curve from greater than the 90th percentile to the 75th percentile or lower. Findings from this study will improve our understanding of the physiologic and behavioral effects of non-pharmacologic intervention to lower elevated lipid levels in children.