28-Day continuous dosing study in minipigs with a SALATRIM structured triacylglycerol composed of stearate, acetate, and propionate

SALATRIM 23SO lot A026 belongs to a family of structured triacylglycerols with lower caloric availability (4.5-6.0 kcal/g) than corn oil 9 kcal/g). Male and female minipigs were divided into five groups of four pigs of each sex and fed diets containing 0%, 3%, 6%, and 10% SALATRIM or 10% corn oil, as a reference for the high fat content of the SALATRIM diets, for 28 days. Diets were supplemented with 2% corn oil to ensure adequate essential fatty acid availability. No effects on body weight, feed consumption, clinical observations, hematology, serum chemistry, bone mineral content, serum and liver levels of fat-soluble vitamins, and organ weights were detected. Focal hepatocellular vacuolation was observed in treated and control groups. The incidence was similar among groups. Because minimally increased severity of vacuolation was observed in only one male in each of the 10% SALATRIM and corn oil treatments, this appears to be a spurious finding or a nonspecific fat effect. SALATRIM 23SO lot A026 produced neither toxicologically nor nutritionally significant effects