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

David J. A. Jenkins, MD;Peter J. H. Jones, PhD;Benoit Lamarche, PhD;Cyril W. C. Kendall, PhD;Dorothea Faulkner, PhD;Luba Cermakova MSc;Iris Gigleux, MSc;Vanu Ramprasath, PhD;Russell de Souza, SD;Chris Ireland, BSc;Darshna Patel, BA;Korbua Srichaikul, MSc;Shahad Abdulnour, MSc;Balachandran Bashyam, PhD;Cheryl Collier, MSc;Sandy Hoshizaki, BSc;Robert G. Josse, MD;Lawrence A. Leiter, MD;Philip W. Connelly, PhD;Jiri Frohlich, MD

Context Combining foods with recognized cholesterol-lowering properties (dietary portfolio) has proven highly effective in loweringserum 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 lipoproteincholesterol (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 (QuebecCity, Toronto, Winnipeg, and Vancouver) randomized between June 25, 2007, and February 19, 2009, to 1 of 3 treatments lasting6 months.Intervention Participants received dietary advice for 6 months on either a low? saturated fat therapeutic diet (control) or a dietaryportfolio, 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 dietaryportfolio 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 differentbetween treatments (18% for intensive dietary portfolio, 23% for routine dietary portfolio, and 26% for control; Fisher exacttest, 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 controldiet (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 thedietary 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 6months of follow-up.Trial Registration clinicaltrials.gov Identifier: NCT00438425