ALA & EPA/DHA (w-3) Effects On Inflammatory Markers in Insulin Resistant Adults

描述（由申请人提供）：背景：已发现一种特定类型的膳食多不饱和脂肪-ω-3脂肪酸（w-3 FAs）-可预防心血管疾病死亡。这些饮食中的w-3脂肪酸一般有两种来源：海洋来源提供EPA和DHA，植物食物来源提供ALA。这些也作为营养补充剂广泛提供。其中一种形式或另一种形式是否更有效地预防疾病仍然存在争议。部分争议是由于缺乏共识的最佳剂量从不同的来源和/或不同类型的人研究。对于那些甘油三酯和炎症标志物水平升高的胰岛素抵抗（代谢综合征）患者，潜在的益处可能会增加。长期目标是比较不同剂量和来源的w-3 FA对炎症标志物和相关健康指标的潜在影响。具体目标：第一个目标是对比海洋型w-3 FA与植物型w-3 FA（EPA + DHA与ALA）。第二个目的是对比这些类型的w-3 FA中的每一种的两种剂量。选择较低剂量是为了反映严格从食物来源获得的高但现实的剂量。较高剂量将是较低剂量的3倍，并且只有在除了食物来源之外还服用膳食补充剂的情况下才可能实际实现。设计：随机临床试验。100名被发现患有“代谢综合征”的成年人，他们患心脏病的风险增加，将被随机分配到安慰剂组，或服用四种w-3 FA方案之一，为期八周：低EPA/DHA，高EPA/DHA，低ALA或高ALA（即每组20人）。将在多个时间点（0、2、4和8周）采集血样，以检查补充剂摄入持续时间对研究结果的影响。主要研究结果是CRP、IL-6、TNF-α和sICAM-1。重要性：这种通常安全且相对便宜的心脏病预防和治疗饮食方法具有相当大的潜力，但需要更多关于w-3 FA的最佳剂量和来源的信息，以及哪些特定的炎症标志物可能参与其影响。本研究选择的患有代谢综合征的成年人是那些心脏病风险增加的人，也是那些最有可能从测试的不同疗法中受益的人。

DESCRIPTION (provided by applicant): BACKGROUND: A specific type of dietary polyunsaturated fat - omega-3 fatty acids (w-3 FAs) - has been found to be protective of death from cardiovascular disease. There are two general sources of these dietary w-3 FAs: marine sources provide EPA and DHA, and plant food sources provide ALA. These are also widely available as nutritional supplements. Whether one form or the other is more effective in disease prevention remains controversial. Part of the controversy is due to the lack of consensus on optimal doses from the different sources and/or to the different types of people studied. Potential benefits are likely to be increased for those with insulin resistance (the metabolic syndrome) who have elevated levels of both triglycerides and inflammatory markers. LONG TERM OBJECTIVE is to contrast different doses and sources of w-3 FA's for their potential effects on inflammatory markers and related health measures. SPECIFIC AIMS: The first aim is to contrast the marine type w-3 FAs to the plant-based w-3 FAs (EPA + DHA vs. ALA). The second aim is to contrast two doses of each of these types of w-3 FAs. The lower dose has been selected to be reflective of what would be considered a high but realistic dose to obtain strictly from food sources. The higher dose will be 3 times the lower dose and would likely only be realistically achievable if dietary supplements were consumed in addition to food sources. DESIGN: A randomized clinical trial will be employed in this study. One hundred adults found to have the "metabolic syndrome", who are at increased risk of heart disease, will be randomly assigned to either a placebo group, or to take one of four w-3 FA regimens for eight weeks: Low EPA/DHA, High EPA/DHA, Low ALA or High ALA (i.e. 20 per group). Blood samples will be collected at multiple time points (0, 2, 4 and 8 weeks) to examine the effect of the duration of supplement intake on study outcomes. The primary study outcomes are CRP, IL-6, TNF- alpha, and slCAM-1. SIGNIFICANCE: This generally safe and relatively inexpensive dietary approach to heart disease prevention and treatment has considerable potential, but more information is needed regarding optimal doses and sources of w-3 FAs, as well as what particular markers of inflammation may be involved in its effects. The adults with the metabolic syndrome selected for this study are those that are at increased risk of heart disease, and those most likely to be benefit from the different therapies tested.