CLINICAL-STUDY OF THE EFFECTS OF EXPOSURE OF VARIOUS SALATRIM PREPARATIONS TO SUBJECTS IN A FREE-LIVING ENVIRONMENT

Three different members of the SALATRIM family of triacylglycerols have been tested in a 42-day clinical study with free living subjects. The study included a 1-week pre-exposure period, a 4-week exposure period, and a 1-week post-exposure period. In the pre- and post-exposure periods, all subjects received 60 g/day of control fat (partially hydrogenated soy oil). During the exposure period, three groups of subjects were fed different levels (30, 45, or 60 g/day) of SALATRIM prepared through interesterification of triacetin, with hydrogenated soy (SALATRIM 23SO); one group was fed 60 g/day of SALATRIM prepared with tripropionin, tributyrin, and hydrogenated soy (43SO); and one group was fed SALATRIM. prepared with tributyrin acid and hydrogenated soy (4SO); two control groups were fed control fat for the entire duration of the study. Increases in AST and ALT observed in the 60 g/day SALATRIM groups were larger than that observed in the control groups; however, the mean values remained well within the normal ranges. After the initial increase, the ALT and AST levels decreased, approaching the levels observed at the beginning of the exposure period. The changes in AST and ALT appeared to be associated with the high-fat diet, since excursions were noted for both the control and SALATRIM groups. Some subjects reported increased levels of gastrointestinal discomfort. These complaints were observed more frequently in the high-dose SALATRIM group. This study also shows that ingestion of SALATRIM will not produce any clinically important effects at the anticipated use level.