Cholesterol-lowering effect of stanol ester in a US population of mildly hypercholesterolemic men and women: a randomized controlled trial.
OBJECTIVE
To determine the efficacy of stanol esters in lowering cholesterol in a US population.


METHODS
After a run-in phase, 318 subjects were randomized to receive one of the following margarine-like spreads containing stanol ester or placebo for 8 weeks: EU 3 G: 1 g of stanol (ester form) per 8-g serving of a European formula 3 times a day; US 3 G: 1 g of stanol (ester form) per 8-g serving of a US reformulation 3 times a day; US 2 G: 0.67 g of stanol (ester form) per 8-g serving of a US reformulation 3 times a day; or placebo spread.


RESULTS
Mean +/- SD baseline total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) levels were 233+/-20 and 153+21 mg+/-dL, respectively. In the US 3 G group, 3 g daily of stanol esters lowered TC and LDL-C levels by 6.4% and 10.1%, respectively. There was a dose-dependent response compared with 2 g daily (US 2 G). Triglyceride and high-density lipoprotein cholesterol levels were unchanged. The incidence of adverse effects was not different from placebo. Serum vitamin A and 25-hydroxyvitamin D levels were not affected.


CONCLUSIONS
Stanol esters lowered TC and LDL-C levels in a mildly hypercholesterolemic US population without evidence of adverse effects. It may be a useful dietary adjunct to lower cholesterol.
Nguyen
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TT
Division of Endocrinology, Metabolism, Nutrition and Internal Medicine, Mayo Clinic Rochester, Minn 55905, USA.
Dale
L C
LC
von Bergmann
K
K
Croghan
I T
IT
D000328:Adult; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D002777:Cholestanols / Q000378:metabolism*; D002784:Cholesterol / Q000031:analogs & derivatives / Q000097:blood*; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004041:Dietary Fats / Q000008:administration & dosage / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004952:Esters / Q000008:administration & dosage / Q000494:pharmacology; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000178:diet therapy / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010840:Phytosterols / Q000008:administration & dosage / Q000097:blood / Q000494:pharmacology*; D012855:Sitosterols / Q000097:blood; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood; D014481:United States; D014801:Vitamin A / Q000097:blood; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood; D019207:beta Carotene / Q000097:blood
D000924:Anticholesteremic Agents; D002777:Cholestanols; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D004041:Dietary Fats; D004952:Esters; D010840:Phytosterols; D012855:Sitosterols; D014280:Triglycerides; D019207:beta Carotene; D014801:Vitamin A; D014807:Vitamin D; C003535:campestanol; C021273:campesterol; C025473:gamma-sitosterol; C001521:lathosterol; D002784:Cholesterol; C104450:25-hydroxyvitamin D; C021255:stigmastanol