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1 From the University of Iowa Hospitals and Clinics, Department of Pediatrics, Iowa City; the National Heart, Lung, and Blood Institute, Division of Epidemiology and Clinical Applications, Bethesda, MD; the Northwestern University Medical School, Department of Preventive Medicine, Chicago; the Johns Hopkins Hospital, School of Medicine, Department of Pediatrics, Baltimore; the Maryland Medical Research Institute, Baltimore; the Kaiser Permanente Center for Health Research, Kaiser Foundation Hospitals, Portland, OR; the Johns Hopkins Hospital, Children's Medical and Surgical Center, Baltimore; the Children's Hospital of Alabama, Department of Gastrointestinal Nutrition, Birmingham; the University of Pittsburgh School of Medicine, Department of Clinical Epidemiology and Preventive Medicine, Pittsburgh; and the New Jersey Medical School, Preventive Cardiology Program, Newark.
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 810 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 cholesterolkJ-1d-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.Am J Clin Nutr 2000;72(suppl): 1332S42S.
Key Words: Efficacy safety lower-fat diets prepubertal children Dietary Intervention Study in Children dietary fat LDL cholesterol
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