The effect of long-term microcrystalline chitosan therapy on plasma lipids and glucose concentrations in subjects with increased plasma total cholesterol: a randomised placebo-controlled double-blind crossover trial in healthy men and women.
OBJECTIVE
To evaluate the long-term effect of microcrystalline chitosan (MCC) on plasma lipids, especially the concentration of low-density lipoprotein (LDL) cholesterol, in subjects with a moderately increased concentration of plasma total cholesterol.


METHODS
A total of 130 middle-aged men and women without severe disease and with a total cholesterol of 4.8-6.8 mmol/l and triglycerides below 3.0 mmol/l were randomised into two treatment groups. At the beginning of the 10-month trial, all participants received placebo 1.2 g twice daily during a 1-month run-in period. Subsequently, group 1 first received 1.2 g placebo twice daily for 3 months and then 1.2 g MCC twice daily for 3 months. Correspondingly, group 2 received 1.2 g MCC twice daily during the first and 1.2 g placebo twice daily during the second 3-month period. During the final 3-month follow-up period, both groups received MCC. Altogether, 83 participants completed the study.


RESULTS
No difference was detected in the change in the LDL-cholesterol concentration between the treatments during the crossover trial ( P=0.98 for interaction between time period and treatment group, repeated-measures analysis of variance for crossover design). In an otherwise similar analysis, no differences were detected between the treatments in the concentrations of total cholesterol, high-density lipoprotein cholesterol, triglycerides and glucose.


CONCLUSIONS
Treatment with MCC had no effect on the concentrations of plasma lipids or glucose in healthy middle-aged men and women with moderately increased plasma cholesterol concentrations.
Metso
Saara
S
Department of Internal Medicine, Tampere University Hospital, P.O. Box 2000, 33521, Tampere, Finland. saara.metso@pshp.fi
Ylitalo
Ritva
R
Nikkilä
Matti
M
Wuolijoki
Erkki
E
Ylitalo
Pauli
P
Lehtimäki
Terho
T
D000277:Adjuvants, Pharmaceutic / Q000737:chemistry / Q000494:pharmacology*; D001786:Blood Glucose / Q000032:analysis*; D002686:Chitin / Q000031:analogs & derivatives* / Q000737:chemistry / Q000494:pharmacology*; D048271:Chitosan; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D018592:Cross-Over Studies; D003460:Crystallization; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance
D000277:Adjuvants, Pharmaceutic; D001786:Blood Glucose; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D008055:Lipids; D002686:Chitin; D048271:Chitosan