Lipid effects of a dietary supplement softgel capsule containing plant sterols/stanols in primary hypercholesterolemia.
OBJECTIVE
This randomized, placebo-controlled, crossover trial assessed the lipid-altering efficacy of a softgel capsule dietary supplement, providing esterified plant sterols/stanols 1.8 g/d, in 28 participants (≈ 75% women) with primary hypercholesterolemia (fasting low-density lipoprotein cholesterol [LDL-C] levels ≥ 130 and <220 mg/dL), a mean age of 58.4 y, and a mean body mass index of 27.9 kg/m(2).


METHODS
After a 5-wk National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Changes (TLC) diet and a single-blinded placebo lead-in, subjects received double-blinded placebo or sterol/stanol softgel capsules for 6 wk and then crossed over to the opposite product for 6 wk while continuing the TLC diet. Fasting lipids were assessed in duplicate at the end of the diet lead-in (baseline) and the end of each treatment.


RESULTS
The mean baseline lipid concentrations (milligrams per deciliter) were 223 for total cholesterol (TC), 179 for non-high-density lipoprotein cholesterol (non-HDL-C), 154 for low-density lipoprotein cholesterol, 44 for HDL-C, 125 for triacylglycerols, and 5.2 for TC/HDL-C. Differences from the control responses (plant sterol/stanol minus control) in the per-protocol sample were significant (P < 0.05) for LDL-C (-9.2%), non-HDL-C (-9.0%), TC (-7.4%), TC/HDL-C (-5.4%), and triacylglycerols (-9.1%). The HDL-C responses were not significantly different between treatments.


CONCLUSIONS
The incorporation of softgel capsules providing esterified plant sterols/stanols 1.8 g/d into the NCEP TLC diet produced favorable changes in atherogenic lipoprotein cholesterol levels in these subjects with hypercholesterolemia.
Biofortis Clinical Research, Addison, Illinois, USA. KMaki@mxns.com
Kevin C
KC
Maki
Andrea L
AL
Lawless
Matthew S
MS
Reeves
Kathleen M
KM
Kelley
Mary R
MR
Dicklin
Belinda H
BH
Jenks
Ed
E
Shneyvas
James R
JR
Brooks
D002214:Capsules; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D018592:Cross-Over Studies; D019587:Dietary Supplements; D005260:Female; D005782:Gels; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood* / Q000188:drug therapy*; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D010840:Phytosterols / Q000008:administration & dosage*; D008517:Phytotherapy; D016037:Single-Blind Method; D014280:Triglycerides / Q000097:blood
D002214:Capsules; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D005782:Gels; D008055:Lipids; D010840:Phytosterols; D014280:Triglycerides; D002784:Cholesterol