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.
D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D002149:Energy Intake; D005227:Fatty Acids; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000178:diet therapy / Q000188:drug therapy*; D008074:Lipoproteins / Q000097:blood; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D013395:Sucrose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014280:Triglycerides / Q000097:blood; D014815:Vitamins / Q000097:blood
D000924:Anticholesteremic Agents; D005227:Fatty Acids; D008074:Lipoproteins; D014280:Triglycerides; D014815:Vitamins; D013395:Sucrose; C013692:sucrose polyester