OBJECTIVES: The objective of the study was to evaluate the effects of plant stanol esters and bran fiber on lipids, stool weight and stool frequency in preschool children. METHODS: The present study was a 13 week open cross-over study designed to evaluate the effects of plant stanol ester in healthy two to five year old preschool children. After a one week lead-in, eligible children were randomly assigned to begin with either Diet Phase A (plant stanol ester) or Phase B (wheat bran fiber). Each diet phase was four weeks long, followed by a two-week wash-out, and then cross-over to the alternate diet. During Diet Phase A children consumed three eight-gram servings of a spread, each containing one gram of plant stanols, for total daily dose of three grams. During Diet Phase B, children added five grams of dietary fiber to their diet for the first two weeks and then ten grams for the second two weeks. RESULTS: Overall, for the whole study group, plant-stanol-ester spread use yielded a decrease in total cholesterol of 19.9 mg/dL (12.4% reduction from baseline) and a 14.6 mg/dL decrease in LDL cholesterol (15.5% reduction from baseline). There were no significant changes in HDL-cholesterol or triglyceride levels. A predominately insoluble dietary fiber supplement derived from wheat bran, as expected, yielded a small but non-significant decrease in total cholesterol of 6.1 mg/dL, a four percent reduction from baseline. CONCLUSIONS: Results demonstrated that preschool age children could adhere to a program requiring consumption of three daily servings of spread containing plant stanol ester and that this level of consumption resulted in a significant decrease in total cholesterol and LDL cholesterol after a four week period. In addition, consumption of plant stanol ester was not associated with any short-term adverse health effects.
RCT Entities:
OBJECTIVES: The objective of the study was to evaluate the effects of plant stanol esters and bran fiber on lipids, stool weight and stool frequency in preschool children. METHODS: The present study was a 13 week open cross-over study designed to evaluate the effects of plant stanol ester in healthy two to five year old preschool children. After a one week lead-in, eligible children were randomly assigned to begin with either Diet Phase A (plant stanol ester) or Phase B (wheat bran fiber). Each diet phase was four weeks long, followed by a two-week wash-out, and then cross-over to the alternate diet. During Diet Phase A children consumed three eight-gram servings of a spread, each containing one gram of plant stanols, for total daily dose of three grams. During Diet Phase B, children added five grams of dietary fiber to their diet for the first two weeks and then ten grams for the second two weeks. RESULTS: Overall, for the whole study group, plant-stanol-ester spread use yielded a decrease in total cholesterol of 19.9 mg/dL (12.4% reduction from baseline) and a 14.6 mg/dL decrease in LDL cholesterol (15.5% reduction from baseline). There were no significant changes in HDL-cholesterol or triglyceride levels. A predominately insoluble dietary fiber supplement derived from wheat bran, as expected, yielded a small but non-significant decrease in total cholesterol of 6.1 mg/dL, a four percent reduction from baseline. CONCLUSIONS: Results demonstrated that preschool age children could adhere to a program requiring consumption of three daily servings of spread containing plant stanol ester and that this level of consumption resulted in a significant decrease in total cholesterol and LDL cholesterol after a four week period. In addition, consumption of plant stanol ester was not associated with any short-term adverse health effects.