Context To enhance the effectiveness of diet in lowering cholesterol, recommendations
of the Adult Treatment Panel III of the National Cholesterol Education Program
emphasize diets low in saturated fat together with plant sterols and viscous
fibers, and the American Heart Association supports the use of soy protein
Objective To determine whether a diet containing all of these recommended food
components leads to cholesterol reduction comparable with that of 3-hydroxy-3-methylglutaryl
coenzyme A reductase inhibitors (statins).
Design Randomized controlled trial conducted between October and December 2002.
Setting and Participants Forty-six healthy, hyperlipidemic adults (25 men and 21 postmenopausal
women) with a mean (SE) age of 59 (1) years and body mass index of 27.6 (0.5),
recruited from a Canadian hospital-affiliated nutrition research center and
Interventions Participants were randomly assigned to undergo 1 of 3 interventions
on an outpatient basis for 1 month: a diet very low in saturated fat, based
on milled whole-wheat cereals and low-fat dairy foods (n = 16; control); the
same diet plus lovastatin, 20 mg/d (n = 14); or a diet high in plant sterols
(1.0 g/1000 kcal), soy protein (21.4 g/1000 kcal), viscous fibers (9.8 g/1000
kcal), and almonds (14 g/1000 kcal) (n = 16; dietary portfolio).
Main Outcome Measures Lipid and C-reactive protein levels, obtained from fasting blood samples;
blood pressure; and body weight; measured at weeks 0, 2, and 4 and compared
among the 3 treatment groups.
Results The control, statin, and dietary portfolio groups had mean (SE) decreases
in low-density lipoprotein cholesterol of 8.0% (2.1%) (P = .002), 30.9% (3.6%) (P<.001), and 28.6%
(3.2%) (P<.001), respectively. Respective reductions
in C-reactive protein were 10.0% (8.6%) (P = .27),
33.3% (8.3%) (P = .002), and 28.2% (10.8%) (P = .02). The significant reductions in the statin and
dietary portfolio groups were all significantly different from changes in
the control group. There were no significant differences in efficacy between
the statin and dietary portfolio treatments.
Conclusion In this study, diversifying cholesterol-lowering components in the same
dietary portfolio increased the effectiveness of diet as a treatment of hypercholesterolemia.