Efficacy and safety of lowering dietary intake of total fat, saturated fat, and cholesterol in children with elevated LDL cholesterol: The dietary intervention study in children

Background: Few studies have shown the efficacy and safety of lower-fat diets in children. Objective: Our objective was to assess the efficacy and safety of lowering dietary intake of total fat, saturated fat, and cholesterol to decrease LDL-cholesterol concentrations in children. Design: A 6-center, randomized controlled clinical trial was carried out in 663 children aged 8-10 y with LDL-cholesterol concentrations greater than the 80th and less than the 98th percentiles for age and sex. The children were randomly assigned to either an intervention group or a usual care group. Behavioral intervention promoted adherence to a diet providing 28% of energy from total fat, <8% from saturated fat, ≤9% from polyunsaturated fat, and < 0.018 mg cholesterol- kJ^-1. d^-1 (not to exceed 150 mg/d). The primary efficacy measure was mean LDL cholesterol and the safety measures were mean height and serum ferritin concentration at 3 y. Results: At 3 y, dietary total fat, saturated fat, and cholesterol were lower in the intervention group than in the usual care group (all P < 0.001). LDL cholesterol decreased in the intervention and usual care groups by 0.40 mmol/L (15.4 mg/dL) and 0.31 mmol/L (11.9 mg/dL), respectively. With adjustment for baseline concentration, sex, and missing data, the mean difference between groups was -0.08 mmol/L (95% CI: -0.15, -0.01), or -3.23 mg/dL (95% CI: -5.6, -0.5) (P = 0.016). There were no significant differences between groups in adjusted mean height or serum ferritin. Conclusion: Dietary changes are effective in achieving modest lowering of LDL cholesterol over 3 y while maintaining adequate growth, iron stores, nutritional adequacy, and psychological well-being during the critical growth period of adolescence.