两种强度的降脂食物膳食组合方案对高脂血症患者血清脂质的影响：一项随机对照试验。

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.

机构信息

Clinical Nutrition and Risk Factor Modification Center, St Michael's Hospital, 61 Queen St E, Toronto, ON M5C 2T2, Canada.

出版信息

JAMA. 2011 Aug 24;306(8):831-9. doi: 10.1001/jama.2011.1202.

DOI:10.1001/jama.2011.1202

PMID:21862744

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.

摘要

背景

在代谢控制条件下，将具有公认降低胆固醇特性的食物组合（饮食组合）已被证明可非常有效地降低血清胆固醇。

目的

评估在两种强度水平下给予饮食组合对根据自身选择的饮食进行治疗的参与者的低密度脂蛋白胆固醇（LDL-C）百分比变化的影响。

设计、设置和参与者：2007 年 6 月 25 日至 2009 年 2 月 19 日，在加拿大 4 个学术中心（魁北克市、多伦多、温尼伯和温哥华）的 351 名高脂血症参与者中进行了一项平行设计的研究，将参与者随机分为 3 种治疗组之一，持续 6 个月。

干预措施

参与者接受了为期 6 个月的低饱和脂肪治疗饮食（对照组）或饮食组合的饮食建议，饮食组合的咨询频率不同，强调在饮食中摄入植物固醇、大豆蛋白、粘性纤维和坚果。常规饮食组合在 6 个月内进行 2 次就诊，强化饮食组合在 6 个月内进行 7 次就诊。

主要观察指标

血清 LDL-C 的百分比变化。

结果

在对 345 名参与者进行的意向治疗分析中，治疗之间的总体失访率没有显著差异（强化饮食组合为 18%，常规饮食组合为 23%，对照组为 26%；Fisher 确切检验，P =.33）。从总体平均 LDL-C 水平 171 mg/dL（95%置信区间[CI]，168-174 mg/dL）的降低幅度为-13.8%（95%CI，-17.2%至-10.3%；P <.001）或-26 mg/dL（95%CI，-31 至-21 mg/dL；P <.001），强化饮食组合为-13.1%（95%CI，-16.7%至-9.5%；P <.001）或-24 mg/dL（95%CI，-30 至-19 mg/dL；P <.001），常规饮食组合为-3.0%（95%CI，-6.1%至 0.1%；P =.06）或-8 mg/dL（95%CI，-13 至-3 mg/dL；P =.002），对照组。每个饮食组合的 LDL-C 降低百分比均显著高于对照组（P <.001，分别）。两种饮食组合干预措施之间无显著差异（P =.66）。在随机分配到饮食组合干预之一的参与者中，饮食组合上 LDL-C 的降低百分比与饮食依从性相关（r = -0.34，n = 157，P <.001）。