Decrease in serum LDL cholesterol with microcrystalline chitosan

Peroral microcrystalline chitosan (MCCh; 3 capsules, each 400 mg b.i.d.) or placebo was given for 8 weeks in a double-blind manner to 51 healthy obese women just before routine hospital and home meals. Weight records, serum l ipids (total, LDL and HDL cholesterol, triglycerides) and safety laboratory parameters were monitored before the trial and at 4, 6 and 8 weeks of trea tment. In a subgroup of subjects with a body mass index greater than or equ al to 30 who had not changed their eating habits, serum LDL cholesterol dec reased 0.57 +/- 0.72 mmol/l (n = 11) at 4 weeks in the MCCh group and 0.10 +/- 0.60 mmol/l (n = 14) in the placebo group (p < 0.05). At 8 weeks, LDL c holesterol reduction was 0.48 +/- 0.91 mmol/l in the MCCh group and 0.26 +/ - 0.57 mmol/l in the placebo group (p > 0.1). In all subjects, the reductio n in LDL cholesterol at 4 weeks was 0.48 +/- 0.72 mmol/l (n = 24) in MCCh s ubjects and 0.18 +/- 0.58 mmol/l (n = 27) in placebo subjects (p = 0.057), and 0.52 +/- 0.69 mmol/l and 0.31 +/- 0.63 mmol/l, respectively, at 8 weeks (p > 0.1). MCCh did not significantly alter serum total and HDL cholestero l (p > 0.1), but slightly increased serum triglycerides compared to placebo (p = 0.015-0.06). No reductions in weight were observed in any treatment g roup. Chitosan was well tolerated and no serious adverse events or changes in safety laboratory parameters were noted including serum fat-soluble vita mins A and E, and serum Fe++ and transferrin. (C) 1999 Prous Science. All r ights reserved.