A double-blind, placebo-controlled study of sucrose polyester in hypercholesterolemic outpatients.

Sucrose polyester (SPE) was studied in a double-blind, placebo-controlled trial in 91 outpatients with primary hypercholesterolemia. All patients maintained an isocaloric diet with cholesterol intake of 400 mg/day and a polyunsaturated to saturated fat ratio of 0.8 to 1.2 for the duration of the study. The study sequence consisted of a diet lead-in period, a first 8-wk treatment period, a 4-wk washout period, and a second 8-wk treatment period. Subjects were randomly assigned to six groups that differed by SPE dose (8, 16, and 32 g/day) and by the treatment period in which either SPE or an olive oil placebo was given in a bread spread formulation. Compared to placebo, the 8, 16, and 32 g/day doses of SPE decreased low-density lipoprotein cholesterol by 2%, 4% (p less than 0.05), and 5% (p less than 0.05) respectively, without changing high-density lipoprotein cholesterol. On SPE, 14/91 (15%) of the subjects experienced a decrease in low-density lipoprotein cholesterol greater than or equal to 10%, while only 2/91 (2%) showed this decrease with placebo.

Sucrose polyester: substitution for dietary fats in hypocaloric diets in the treatment of familial hypercholesterolemia.

In five obese women heterozygous for familial hypercholesterolemia, we assessed the combination of weight loss and sucrose polyester (SPE) in lowering low-density lipoprotein cholesterol (LDLC). After a 10-day basal hypocaloric (1426 cal/day), 270 mg cholesterol, P/S 1.2:1 diet, an average of 36 g of dietary fat/day was replaced by 36 g of an 80/20 SPE-hydrogenated palm oil mixture, providing 30 g SPE for 30 days; during the SPE substitution period mean dietary cholesterol and P/S were unchanged, mean caloric intake was 1104 cal/day. During the hypocaloric basal diet, mean weight fell 1.2 kg, p less than 0.02, total plasma cholesterol fell 8% from 358 +/- 46 to 330 +/- 47 mg/dl, p less than 0.01, LDLC fell 4% from 264 +/- 37 to 254 +/- 44 mg/dl, p greater than 0.1, and mean high-density lipoprotein cholesterol fell 11%, from 52 +/- 4 to 46 +/- 4, p less than 0.05. Over the 30-day SPE substitution, mean cholesterol fell 20% from 330 +/- 47 at the end of the basal diet to 265 +/- 42 mg/dl, p less than 0.001; mean LDLC fell 23%, from 254 +/- 44 to 195 +/- 41 mg/dl (p less than 0.01); weight fell 4%, p less than 0.01, from 91 +/- 7 to 87 +/- 7 kg, and mean high-density lipoprotein cholesterol fell 11% from 46 +/- 4 to 41 +/- 2, p less than 0.05. Hypocaloric removal of dietary fat by SPE, an artificial fat with culinary properties of conventional dietary fats, effectively reduces LDLC (by 23%) in familial hypercholesterolemia subjects, with additive effects of SPE and weight loss.

Sucrose polyester and covert caloric dilution.

Total daily caloric intake was measured in 10 obese subjects when sucrose polyester (SPE), a nonabsorbable synthetic fat, covertly replaced conventional fats in a single crossover study consisting of three periods: a period of 7 to 14 days to determine baseline caloric intake and two 20-day study periods. An average of 60 g SPE/day replaced conventional fat in one of the two study periods. During both study periods, 60% of the base line caloric intake was "required intake" at mealtime; an additional 60% of base line caloric intake was allowed as "free choice" foods at a specified snacktime. It was thus possible during both study periods to consume more than 100% of the base line caloric intake. In the SPE study period, 40 g SPE replaced 40 g conventional fat for every 1200 kcal of required intake, resulting in a 30% reduction in mealtime caloric intake. Mean total caloric intake (meal and snack) fell 23% during the SPE period (p less than 0.05), despite an average daily weight loss of 0.18 kg. Snack caloric intake did not increase significantly to compensate for caloric dilution of the meals during the SPE period. These results indicate that the obese may not detect or may not compensate for covert dilution of fat calories with SPE. In addition, during the SPE period, there was a 10% reduction in total plasma cholesterol, a 14% reduction in low-density lipoprotein cholesterol, and a 10% reduction in triglyceride concentration. Thus, fat replacement with SPE may benefit weight reduction regimens in obese subjects by facilitating decreased caloric intake and by improving the circulating lipoprotein profile as well.