Clinical assessment of Salatrim, a reduced-calorie triacylglycerol

SALATRIM is a reduced-calorie fat composed of triacylglycerols containing mixtures of short-chain aliphatic acids and long-chain saturated fatty acids. Studies have been conducted in a clinical environment to confirm the predictable metabolism of ingested SALATRIM in humans. An acute tolerance test (study I) was conducted initially with a single ingestion (45 or 60 g), in a double-blind-crossover design with 10 subjects. The levels selected were chosen to significantly exceed expected exposure levels from consumption of foods containing SALATRIM (13.5 or 29.8 g/day at the mean and 90th percentile, respectively). A second more extensive study (study II) was conducted with 36 subjects in a repeated-measures design. Half of the subjects were exposed to either 45 or 60 g of SALATRIM/day for 7 days depending on overall caloric need. The study consisted of a 7-day pretrial period during which subjects received products containing hydrogenated coconut oil, a 7-day period during which half of the subjects received products with SALATRIM and half of the subjects received products with hydrogenated coconut oil, and a final 10-day period during which all subjects received products made with hydrogenated coconut oil. Of 35 physiological indices measured, no clinically significant biochemical responses were observed. Small increases were observed in plasma serum enzymes (AST, ALT, and LDH) with the high SALATRIM exposure, however, mean values for these enzymes remained within the normal range. Some subjects initially experienced mild gastrointestinal effects, associated with the high exposure levels of test material, but none asked to leave the trial. A third clinical trial (study III) was undertaken involving 24 subjects in a triple-crossover study with exposure to 0, 30, and 60 g of SALATRIM/day for 4 consecutive days with a 4-day maintenance diet using hydrogenated coconut oil between treatments. Responses similar to those observed in study II were found at 60 g of SA