title: Evaluation of clinical and biochemical parameters after short term consumption of microparticulated protein fat substitute (Simplesse®) in a frozen dessert.
abstract: The tolerance of microparticulated protein product (MPP, Simplesse®), a protein-based fat substitute, was evaluated in a randomized, double-blind, three-way crossover study using 24 healthy adult subjects (12 males and 12 females). A regular cafeteria diet was given alone or together with two 196 ml servings (approximately 13 fluid ounces) per day of either super premium ice cream (16% butterfat content) or frozen dessert made with MPP for 7 days. The ice cream and MPP desserts were administered in a double-blind manner. Three-day dietary diaries were maintained for each 7-day period. Routine laboratory tests along with plasma lipid panels and amino acid profiles were done prior to study start and after each of the three regimens. Vital signs, body weight, and adverse experiences were monitored regularly. None of the three regimens had a clinically significant effect on routine laboratory tests, body weights, vital signs, or plasma amino acid profiles. Of interest, subjects on the ice cream regimen experienced statistically significant increases, although within the normal range, in plasma total cholesterol, LDL- and HDL-cholesterol, and in apolipoprotein A-l and B concentrations compared to either of the other two regimens. Two mild gastrointestinal adverse experiences were reported during the ice cream regimen. No adverse experiences occurred during the MPP or regular diet regimens. Thus, MPP fat substitute is well moderated and can safely be used in a low-fat diet regimen.
authors: Division of Clinical Pharmacology, Department of Medicine, The University of Kansas Medical Center, Kansas City,KS,USA.
authors: W S
authors: WS
authors: Harris
authors: A
authors: A
authors: Hurwitz
authors: W W
authors: WW
authors: Stargel
authors: T S
authors: TS
authors: Burns
authors: C
authors: C
authors: Tschanz