Effect of free plant sterols in low-fat milk on serum lipid profile in hypercholesterolemic subjects.
OBJECTIVE
To determine the effect of nonesterified, nonhydrogenated plant sterols solubilized in a partly vegetable oil-filled low-fat milk on serum low-density lipoprotein cholesterol (LDL) in mildly hypercholesterolemic patients.


METHODS
Double-blind, randomized, placebo-controlled three-arm crossover study.


METHODS
Outpatient clinical trial.


METHODS
A total of 138 patients were screened, providing 81 patients for randomization; 71 patients completed the study.


METHODS
The study product was a 500 ml milk blend with or without nonesterified, nonhydrogenated sterols. The daily consumption of sterols in the three groups was 0 g/day, control group (C); 1.2 g/day, (Lo); or 1.6 g/day, (Hi), respectively. The patients were randomly assigned to one of three different treatment sequences. Each intervention period was 4 weeks. The total study duration was 12 weeks.


RESULTS
The milk product was well tolerated. The placebo-adjusted mean reduction in LDL was 7.13+/-12.31 and 9.59+/-12.44% (mean+/-s.d.) for Lo and Hi groups, respectively (P<0.0001); there was no statistically significant difference in LDL lowering for the Lo and Hi groups. There were no significant changes in serum vitamin E or carotenoid concentrations after standardization with LDL cholesterol during the study period.


CONCLUSIONS
The present study shows for the first time a substantial reduction in LDL cholesterol with a new, partly vegetable oil-filled 1.2% low-fat milk product, containing nonesterified plant sterols from soybean oil, in a randomized, placebo-controlled trial. This result encourages further development of novel low-fat dairy products containing free plant sterols for future use in cholesterol-lowering initiatives.
Thomsen
A B
AB
Centre of Clinical and Basic Research, Ballerup Byvej, Ballerup, Denmark. abt@ccbr.dk
Hansen
H B
HB
Christiansen
C
C
Green
H
H
Berger
A
A
D000368:Aged; D000818:Animals; D000975:Antioxidants / Q000378:metabolism; D002338:Carotenoids / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood* / Q000187:drug effects; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005527:Food, Fortified; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood* / Q000178:diet therapy*; D008297:Male; D008875:Middle Aged; D008892:Milk / Q000737:chemistry; D010840:Phytosterols / Q000494:pharmacology*; D014810:Vitamin E / Q000097:blood
D000975:Antioxidants; D008078:Cholesterol, LDL; D010840:Phytosterols; D014810:Vitamin E; D002338:Carotenoids