OBJECTIVE: To investigate cholesterol-lowering efficacy and safety of plant stanol ester margarine in healthy 6-year-old children already consuming a low-saturated-fat, low-cholesterol diet. STUDY DESIGN: Eighty-one intervention children from the STRIP project, a randomized prospective trial aimed at reducing exposure of young children to the known environmental atherosclerosis risk factors, were recruited to this double-blind crossover study at 6 years of age. In randomized order the families were advised to replace daily 20 g of the child's dietary fat intake with plant stanol ester margarine or control margarine for 3 months. The washout period lasted 6 weeks. Statistical analysis was performed according to intention-to-treat principle with analysis of variance for crossover design. RESULTS: The mean daily plant stanol ester margarine consumption was 18.2 g (1.5 g plant stanol). The well-tolerated plant stanol ester margarine reduced serum total and low-density lipoprotein cholesterol concentrations by 5.4% and 7.5%, respectively (P =.0001 for both). The serum high-density lipoprotein cholesterol and triglyceride concentrations and alpha-tocopherol to low-density lipoprotein cholesterol ratio remained unchanged. The serum beta-carotene to low-density lipoprotein cholesterol ratio decreased by 19% (P =.003). CONCLUSION:Plant stanol ester margarine significantly diminishes serum total and low-density lipoprotein cholesterol concentration without adverse clinical effects in healthy children who already consume a low-saturated-fat, low-cholesterol diet but decreases the serum beta-carotene to low-density lipoprotein cholesterol ratio.
RCT Entities:
OBJECTIVE: To investigate cholesterol-lowering efficacy and safety of plant stanol ester margarine in healthy 6-year-old children already consuming a low-saturated-fat, low-cholesterol diet. STUDY DESIGN: Eighty-one intervention children from the STRIP project, a randomized prospective trial aimed at reducing exposure of young children to the known environmental atherosclerosis risk factors, were recruited to this double-blind crossover study at 6 years of age. In randomized order the families were advised to replace daily 20 g of the child's dietary fat intake with plant stanol ester margarine or control margarine for 3 months. The washout period lasted 6 weeks. Statistical analysis was performed according to intention-to-treat principle with analysis of variance for crossover design. RESULTS: The mean daily plant stanol ester margarine consumption was 18.2 g (1.5 g plant stanol). The well-tolerated plant stanol ester margarine reduced serum total and low-density lipoprotein cholesterol concentrations by 5.4% and 7.5%, respectively (P =.0001 for both). The serum high-density lipoprotein cholesterol and triglyceride concentrations and alpha-tocopherol to low-density lipoprotein cholesterol ratio remained unchanged. The serum beta-carotene to low-density lipoprotein cholesterol ratio decreased by 19% (P =.003). CONCLUSION: Plant stanol ester margarine significantly diminishes serum total and low-density lipoprotein cholesterol concentration without adverse clinical effects in healthy children who already consume a low-saturated-fat, low-cholesterol diet but decreases the serum beta-carotene to low-density lipoprotein cholesterol ratio.