Evaluation of clinical and biochemical parameters in children after consumption of microparticulated protein fat substitute (Simplesse).

OBJECTIVE

The objective of this randomized, double-blind, two-way crossover study in healthy children was to evaluate whether microparticulated protein (MPP, Simplesse) fat substitute had any effects on various clinical and biochemical parameters when compared to super premium ice cream (approximately 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 serving (approximately 196 mL) 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.

RESULTS

There were no clinically significant effects on any of the parameters following either treatment, although there were statistically significant increases in fasting plasma cholesterol and high-density lipoprotein cholesterol following ice cream when compared to MPP. There were no statistically significant differences between the two treatments in regard to macronutrient consumption. The only adverse experience related to treatment was one episode of vomiting following the ice cream. The children ingested more than five times the amount of MPP than that found in the 90th percentile of frozen dessert consumption by this age group. The protein intake (5.5 g/day) from MPP at this level of consumption would only modestly increase the total daily protein intake.

CONCLUSION

Children ingesting approximately 196 mL/day of frozen dessert made with MPP did not show any clinically significant changes in various clinical and biochemical parameters.