Effects of a Dietary Portfolio of Cholesterol-Lowering Foods vs Lovastatin on Serum Lipids and C-Reactive Protein

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

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).

Corresponding Author and Reprints: David J. A. Jenkins, MD, Clinical Nutrition and Risk Factor Modification Center, St Michael's Hospital, 61 Queen St E, Toronto, Ontario, Canada M5C 2T2 (e-mail: [email protected]).

Financial Disclosure: Dr Jenkins has received research grants from the Almond Board of California, Loblaw Brands Ltd, Yves Fine Foods (now Hain-Celestial Group), and Unilever Canada. Prior to undertaking research, he served on the scientific advisory board of Unilever Canada. He has received honoraria and financial support to attend scientific meetings from the Almond Board of California and Protein Technologies Inc (now Solae).

Author Contributions:Study concept and design: Jenkins, Kendall, Faulkner, Vidgen, Lapsley, Trautwein, Josse, Leiter.

Acquisition of data: Jenkins, Kendall, Marchie, Faulkner, Wong, de Souza, Emam, Parker, Vidgen, Connelly.

Analysis and interpretation of data: Jenkins, Kendall, Faulkner, Parker, Vidgen, Trautwein, Leiter.

Drafting of the manuscript: Jenkins, Kendall, Trautwein.

Critical revision of the manuscript for important intellectual content: Jenkins, Kendall, Faulkner, Marchie, Wong, de Souza, Emam, Parker, Vidgen, Lapsley, Trautwein, Josse, Leiter, Connelly.

Statistical expertise: Vidgen.

Obtained funding: Jenkins, Kendall, Faulkner, Lapsley, Trautwein.

Administrative, technical, or material support: Kendall, Marchie, Faulkner, Wong, de Souza, Emam, Parker, Trautwein, Leiter, Connelly.

Study supervision: Jenkins, Kendall, Faulkner.

Funding/Support: This study was supported by the Canada Research Chair Endowment of the federal government of Canada (CIHR CRC 950-01–31), the Canadian Natural Sciences and Engineering Research Council of Canada (CRD 247854-01), Loblaw Brands Ltd (Toronto, Ontario), the Almond Board of California, and Unilever Canada. Dr Jenkins holds a Canada Research Chair funded by the federal government of Canada.

Acknowledgment: We thank Loblaw Brands Ltd, the Almond Board of California, Unilever Research and Development, the Hain-Celestial Group (Melville, NY), Nestlé Canada Inc (Pickering, Ontario), Kraft Foods (Glenview, Ill), Procter & Gamble Inc (Toronto, Ontario), Bartlett Farms, Barwell Food Sales Inc (London, Ontario), and Burnbrae Farms Ltd (Upton, Quebec) for donation of foods used in this study. We thank Robert Chenaux and Larry C. Griffin of Loblaw Brands Ltd; Paul Schur, PhD, of Unilever Canada; Gerry Amantea, PhD, of the Hain-Celestial Group; Kathy Galbraith of Natural Temptations Bakery, Burlington, Ontario; Margaret C. Martini, PhD, of Kraft Foods; Don Bartlett of Bartlett Farms, Barwell Foods Sales Inc; the Stouffer's Marketing Team of Nestlé Canada; and Margaret Hudson of Burnbrae Farms Ltd, for their assistance on this project, and the study participants for their attention to detail and enthusiasm.

JAMA: The Journal of the American Medical Association 290(4):p 502-510, July 23/30, 2003.

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.