EVALUATION OF CLINICAL AND BIOCHEMICAL PARAMETERS IN CHILDREN AFTER CONSUMPTION OF MICROPARTICULATED PROTEIN FAT SUBSTITUTE (SIMPLESSE(R))

Objective: The objective of this randomized, double-blind, two-way cro ssover study in healthy children was to evaluate whether microparticul ated protein (MPP, Simplesse(R)) fat substitute had any effects on var ious clinical and biochemical parameters when compared to super premiu m ice cream (similar to 16% butterfat). Methods: Twenty-four children (12 males, 12 females), 7-10 years of age, received their normal diet plus two consecutive 7-day treatment regimens consisting of one servin g (similar to 196 mt) per day of either ice cream or a frozen dessert made with MPP. Three-day food diaries, routine hematologies, clinical chemistries, urinalyses, fasting plasma lipids and amino acids, vital signs and adverse experiences were compared between treatments. Result s: There were no clinically significant effects on any of the paramete rs following either treatment, although there were statistically signi ficant increases in fasting plasma cholesterol and high-density lipopr otein cholesterol following ice cream when compared to MPP. There were no statistically significant differences between the two treatments i n regard to macronutrient consumption. The only adverse experience rel ated to treatment was one episode of vomiting following the ice cream. The children ingested more than five times the amount of MPP than tha t found in the 90th percentile of frozen dessert consumption by this a ge group. The protein intake (5.5 g/day) from MPP at this level of con sumption would only modestly increase the total daily protein intake. Conclusion: Children ingesting approximately 196 mL/day of frozen dess ert made with MPP did not show any clinically significant changes in v arious clinical and biochemical parameters.