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Original Contribution
August 24/31, 2011

Effect of a Dietary Portfolio of Cholesterol-Lowering Foods Given at 2 Levels of Intensity of Dietary Advice on Serum Lipids in Hyperlipidemia: A Randomized Controlled Trial

Author Affiliations

Author Affiliations: Clinical Nutrition and Risk Factor Modification Center (Drs Jenkins, Kendall, Faulkner, de Souza, Bashyam, Josse, and Leiter and Mr Ireland and Mss Patel, Srichaikul, and Abdulnour) and Department of Medicine (Drs Jenkins, Josse, and Leiter), St Michael's Hospital, Toronto, Ontario; Departments of Nutritional Sciences (Drs Jenkins, Kendall, Faulkner, de Souza, Bashyam, Josse, and Leiter and Mr Ireland and Mss Patel and Srichaikul) and Medicine (Drs Jenkins, Josse, and Leiter), University of Toronto, Toronto, Ontario; Richardson Center for Functional Foods and Nutraceuticals, University of Manitoba, Winnipeg (Drs Jones and Ramprasath); Institute of Nutraceuticals and Functional Foods, Laval University, Quebec City, Quebec (Dr Lamarche and Ms Gigleux); Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver (Dr Frohlich and Mss Cermakova, Collier, and Hoshizaki); Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario (Dr de Souza); Institute of Medical Science, University of Toronto, Toronto, Ontario (Ms Abdulnour); and Keenan Research Center of the Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario (Drs Jenkins, Josse, Leiter, and Connelly), Canada.

JAMA. 2011;306(8):831-839. doi:10.1001/jama.2011.1202
Abstract

Context Combining foods with recognized cholesterol-lowering properties (dietary portfolio) has proven highly effective in lowering serum cholesterol under metabolically controlled conditions.

Objective To assess the effect of a dietary portfolio administered at 2 levels of intensity on percentage change in low-density lipoprotein cholesterol (LDL-C) among participants following self-selected diets.

Design, Setting, and Participants A parallel-design study of 351 participants with hyperlipidemia from 4 participating academic centers across Canada (Quebec City, Toronto, Winnipeg, and Vancouver) randomized between June 25, 2007, and February 19, 2009, to 1 of 3 treatments lasting 6 months.

Intervention Participants received dietary advice for 6 months on either a low− saturated fat therapeutic diet (control) or a dietary portfolio, for which counseling was delivered at different frequencies, that emphasized dietary incorporation of plant sterols, soy protein, viscous fibers, and nuts. Routine dietary portfolio involved 2 clinic visits over 6 months and intensive dietary portfolio involved 7 clinic visits over 6 months.

Main Outcome Measures Percentage change in serum LDL-C.

Results In the modified intention-to-treat analysis of 345 participants, the overall attrition rate was not significantly different between treatments (18% for intensive dietary portfolio, 23% for routine dietary portfolio, and 26% for control; Fisher exact test, P = .33). The LDL-C reductions from an overall mean of 171 mg/dL (95% confidence interval [CI], 168-174 mg/dL) were −13.8% (95% CI, −17.2% to −10.3%; P < .001) or −26 mg/dL (95% CI, −31 to −21 mg/dL; P < .001) for the intensive dietary portfolio; −13.1% (95% CI, −16.7% to −9.5%; P < .001) or –24 mg/dL (95% CI, −30 to −19 mg/dL; P < .001) for the routine dietary portfolio; and −3.0% (95% CI, −6.1% to 0.1%; P = .06) or −8 mg/dL (95% CI, −13 to −3 mg/dL; P = .002) for the control diet. Percentage LDL-C reductions for each dietary portfolio were significantly more than the control diet (P < .001, respectively). The 2 dietary portfolio interventions did not differ significantly (P = .66). Among participants randomized to one of the dietary portfolio interventions, percentage reduction in LDL-C on the dietary portfolio was associated with dietary adherence (r = −0.34, n = 157, P < .001).

Conclusion Use of a dietary portfolio compared with the low−saturated fat dietary advice resulted in greater LDL-C lowering during 6 months of follow-up.

Trial Registration clinicaltrials.gov Identifier: NCT00438425

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