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David J. A. Jenkins, MD; Cyril W. C. Kendall, PhD; Augustine Marchie, BSc; Dorothea A. Faulkner, PhD; Julia M. W. Wong, RD; Russell de Souza, RD; Azadeh Emam, BSc; Tina L. Parker, RD; Edward Vidgen, BSc; Karen G. Lapsley, DSc; Elke A. Trautwein, PhD; Robert G. Josse, MB, BS; Lawrence A. Leiter, MD; Philip W. Connelly, PhD

JAMA. 2003;290:502-510.

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 and nuts.

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 the community.

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.

Author Affiliations: Clinical Nutrition and Risk Factor Modification Center (Drs Jenkins, Kendall, Faulkner, Josse, and Leiter, Mss Wong, Emam, and Parker, and Messrs Marchie, de Souza, and Vidgen) and Department of Medicine, Division of Endocrinology and Metabolism (Drs Jenkins, Josse, Leiter, and Connelly), St Michael's Hospital, and Departments of Nutritional Sciences (Drs Jenkins, Kendall, Faulkner, Josse, and Leiter, Mss Wong, Emam, and Parker, and Messrs Marchie, de Souza, and Vidgen), Medicine (Drs Jenkins, Josse, and Leiter), Biochemistry (Dr Connelly), and Laboratory Medicine and Pathobiology (Dr Connelly), Faculty of Medicine, University of Toronto, Toronto, Ontario; the Almond Board of California, Modesto (Dr Lapsley); and Unilever Health Institute, Unilever Research and Development, Vlaardingen, the Netherlands (Dr Trautwein).

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