CLINICAL TRIAL: POTENTIAL HEALTH BENEFITS OF DIETARY ANTIOXIDANTS FROM SUPPLEMEN

临床试验：补充剂中膳食抗氧化剂的潜在健康益处

• 批准号: 7717931
• 负责人: CHRISTOPHER D GARDNER
• 金额: $ 2.14万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717931
• 关键词: Adult; Antioxidants; Ascorbic Acid; Atherosclerosis; C-reactive protein; Cardiovascular system; Carotenoids; Clinical; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Consumption; Data; Diet; Dose; Double-Blind Method; Endothelium; Environment; Event; Feasibility Studies; Fibrinogen; Food; Functional disorder; Funding; Future; Grant; Health Benefit; Heart Diseases; Incidence; Inflammation; Inflammatory; Institution; Intercellular adhesion molecule 1; Interleukin-6; Intervention; Isoprostanes; Methodology; Numbers; Nutrient; Outcome; Outcome Study; Pathologic; Placebos; Randomized; Research; Research Personnel; Resources; Risk; Risk Factors; Selenium; Source; Testing; Tocopherols; Tumor Necrosis Factor-alpha; United States National Institutes of Health; Vitamins; Week; cost; design; dietary antioxidant; human TNF protein; novel; pill; research study; urinary

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. BACKGROUND: A number of observational and experimental studies have shown that the recognized risk factors for atherosclerosis promote an inflammatory oxidative environment in the vasculature that is conducive to pathologic changes in the endothelium. Considerable evidence now exists that endothelial dysfunction both precedes and accelerates atherosclerosis. Antioxidant nutrients, including vitamin C, carotenoids, tocopherols and selenium, may therefore be presumed likely to contribute to a decrease of endothelial dysfunction and to diminish the incidence of cardiovascular events. However, the previous use of antioxidant supplements in clinical trials has yielded disappointing and controversial results. Despite the null trial findings, the use of dietary antioxidant vitamins continues to grow in the U.S. OBJECTIVE: In this revised application, our objective is to determine the short-term efficacy of foods naturally rich in antioxidants vs. supplemental pill antioxidants on markers of inflammation in generally healthy subjects at risk of atherosclerosis. DESIGN: This is a randomized, single-blind (diets)/double blind (supplements), parallel, feasibility study. Ninety adults with elevated risk factors for atherosclerosis and heart disease will be randomly assigned to either: 1) continue their usual diet and receive placebo pills (n=30 Usual/Plac), 2) continue their usual diet and receive antioxidant supplement pills (n=30 Usual/Supp), or 3) increase their consumption of antioxidant rich foods closely matched to antioxidant content of the supplement pills (n=30 Antiox-Food) for eight weeks. Data will be collected at baseline, four, and eight weeks. Primary study outcomes are markers of inflammation including C-reactive protein, fibrinogen, IL-6, TNF-alpha and soluble ICAM-1. Secondary outcomes include urinary isoprostanes. IMPLICATIONS: This study is designed to evaluate the responsiveness of novel markers of atherosclerosis to antioxidant interventions. Tests of inflammatory markers and endothelial function may provide a rapid and reliable methodology to assess the clinical outcome of antioxidant interventions at low cost and allow for fine tuning the choice of optimal combinations, sources and doses of antioxidants for future longer term and larger scale studies.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 背景：大量观察和实验研究表明，公认的动脉粥样硬化危险因素会促进脉管系统中的炎症氧化环境，从而有利于内皮的病理变化。 现在存在大量证据表明内皮功能障碍先于动脉粥样硬化并加速动脉粥样硬化。因此，抗氧化营养素，包括维生素 C、类胡萝卜素、生育酚和硒，可能有助于减少内皮功能障碍并降低心血管事件的发生率。 然而，之前在临床试验中使用抗氧化剂补充剂却取得了令人失望且有争议的结果。 尽管试验结果无效，但膳食抗氧化维生素的使用在美国仍在持续增长。 目的：在这个修订后的申请中，我们的目标是确定天然富含抗氧化剂的食物与补充抗氧化剂的药丸对有动脉粥样硬化风险的一般健康受试者的炎症标志物的短期疗效。 设计：这是一项随机、单盲（饮食）/双盲（补充剂）、平行的可行性研究。 90 名动脉粥样硬化和心脏病风险因素较高的成年人将被随机分配到以下组之一：1) 继续日常饮食并服用安慰剂药片 (n=30 Usual/Plac)，2) 继续日常饮食并接受抗氧化剂补充药丸 (n=30 Usual/Supp)，或 3) 增加与补充药丸抗氧化剂含量密切相关的富含抗氧化剂的食物的摄入量 (n=30) 抗氧化食品）八周。 将在基线、四周和八周收集数据。 主要研究结果是炎症标志物，包括 C 反应蛋白、纤维蛋白原、IL-6、TNF-α 和可溶性 ICAM-1。 次要结果包括尿异前列腺素。 意义：本研究旨在评估新型动脉粥样硬化标志物对抗氧化干预措施的反应性。 炎症标志物和内皮功能的测试可以提供一种快速可靠的方法来以低成本评估抗氧化干预的临床结果，并允许为未来的长期和更大规模的研究微调抗氧化剂的最佳组合、来源和剂量的选择。