S A Ribas1, R Sichieri2, A S B Moreira3, D O Souza4, C T F Cabral4, D T Gianinni4, D B Cunha2. 1. Nutrition Division, State University of Rio de Janeiro, Brazil. Electronic address: ribasnut@yahoo.com.br. 2. Institute of Social Medicine, State University of Rio de Janeiro, Brazil. 3. Nutrition Institute, Rio de Janeiro State University, Brazil. 4. Nutrition Division, State University of Rio de Janeiro, Brazil.
Abstract
BACKGROUND AND AIMS: Despite evidence of the lipid-lowering effect of plant sterols among adults with hypercholesterolemia, data regarding phytosterol use in children are limited. In this paper, we examined the effects of daily consumption of a phytosterol-enriched milk compound on the lipid profiles of Brazilian children and adolescents with dyslipidemia. METHODS AND RESULTS: This was a randomized, double blind, crossover clinical trial. Twenty eight dyslipidemics outpatients (aged 6-9 years) from an University Hospital were randomly allocated to control or intervention group. The intervention group received milk enriched with 1.2 g/day of plant sterol and the control group received the equivalent amount of skim milk during the period of 8 weeks. Changes from baseline in the mean lipid profile, including total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), and triglyceride (TG) concentrations. Serum lipid profiles, glucose levels, dietary and anthropometric data were determined at weeks 0, 4, 8, 16, and 20. Details regarding the safety and tolerance of phytosterol were obtained, using an open-ended questionnaire. Intention-to-treat analysis were performed, using the proc mixed procedure in SAS. After 8 weeks, the mean concentrations of TC and LDL-C were significantly reduced in the intervention group as compared to the control group with reductions of 5.9% (p = 0.09) and 10.2% (p = 0.002), respectively. In addition, TG concentrations were reduced by 19.7% (p = 0.09). No serious side effects were reported during the study. CONCLUSION: Our results confirm that plant sterols are an effective and safe treatment of infantile dyslipidemia. TRIAL REGISTRATION: RBR-3h7f9k.
RCT Entities:
BACKGROUND AND AIMS: Despite evidence of the lipid-lowering effect of plant sterols among adults with hypercholesterolemia, data regarding phytosterol use in children are limited. In this paper, we examined the effects of daily consumption of a phytosterol-enriched milk compound on the lipid profiles of Brazilian children and adolescents with dyslipidemia. METHODS AND RESULTS: This was a randomized, double blind, crossover clinical trial. Twenty eight dyslipidemics outpatients (aged 6-9 years) from an University Hospital were randomly allocated to control or intervention group. The intervention group received milk enriched with 1.2 g/day of plant sterol and the control group received the equivalent amount of skim milk during the period of 8 weeks. Changes from baseline in the mean lipid profile, including total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), and triglyceride (TG) concentrations. Serum lipid profiles, glucose levels, dietary and anthropometric data were determined at weeks 0, 4, 8, 16, and 20. Details regarding the safety and tolerance of phytosterol were obtained, using an open-ended questionnaire. Intention-to-treat analysis were performed, using the proc mixed procedure in SAS. After 8 weeks, the mean concentrations of TC and LDL-C were significantly reduced in the intervention group as compared to the control group with reductions of 5.9% (p = 0.09) and 10.2% (p = 0.002), respectively. In addition, TG concentrations were reduced by 19.7% (p = 0.09). No serious side effects were reported during the study. CONCLUSION: Our results confirm that plant sterols are an effective and safe treatment of infantile dyslipidemia. TRIAL REGISTRATION: RBR-3h7f9k.