Effect of Antioxidants on Inflammatory Markers and FMVD

抗氧化剂对炎症标志物和 FMVD 的影响

基本信息

批准号：
7295686
负责人：
CHRISTOPHER D GARDNER
金额：
$ 30.3万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-09-30 至 2009-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7295686
关键词：
Acute-Phase Proteins Adherence Adult Antioxidants Area Ascorbic Acid Atherosclerosis Automobile Driving Biological Biological Markers Cardiovascular Diseases Cardiovascular system Carotenoids Cell Adhesion Characteristics Clinical Clinical Trials Consumption Counseling Critiques Daily Data Development Diet Dietitian Disease Dose Double-Blind Method Eating Endothelium Environment Epidemic Epidemiologic Studies Evaluation Methodology Event Exclusion Criteria Failure Feasibility Studies Fibrinogen Follow-Up Studies Food Functional disorder Future Goals Hand Health Health Priorities Heart Diseases ICAM1 gene Incidence Inflammation Inflammatory Injury Intake Intercellular adhesion molecule 1 Interleukin-6 Intervention Intervention Studies Investigation Isoprostanes Lead Literature Mediating Methodology Numbers Nutrient Outcome Outcome Assessment Outcome Measure Outcome Study Oxidative Stress Participant Pathologic Phytochemical Placebos Population Population Study Principal Investigator Process Proteins Protocols documentation Public Health Publishing Randomized Randomized Clinical Trials Range Recruitment Activity Reporting Reproducibility Research Research Personnel Risk Risk Factors Role Sample Size Selenium Source Suggestion Surrogate Endpoint Surrogate Markers Testing Tocopherols Tumor Necrosis Factor-alpha United States National Institutes of Health Upper arm Vasodilation Vitamins Week atherogenesis brachial artery cost cysteine rich protein cytokine design dietary antioxidant follow-up human TNF protein innovation interest novel pill programs research study response sound urinary

项目摘要

DESCRIPTION (provided by applicant): 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 and endothelial function 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 flow mediated vasodilation of the brachial artery and 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.

描述（由申请人提供）：背景：许多观察性和实验研究表明，动脉粥样硬化的公认危险因素促进了脉管系统中炎症性氧化环境，这有利于内皮的病理变化。现在有大量证据表明，内皮功能障碍既先于动脉粥样硬化，也可以加速动脉粥样硬化。因此，可以认为抗氧化剂营养素，包括维生素C，类胡萝卜素，生育酚和硒，可能会假定可能导致内皮功能障碍降低并减少心血管事件的发生率。但是，在临床试验中先前使用抗氧化剂补充剂已产生令人失望和有争议的结果。尽管进行了无效的试验结果，但在美国的目标中，使用饮食中抗氧化剂维生素的使用仍在增长：在这种修订后的应用中，我们的目标是确定食物的短期疗效自然富含抗氧化剂的抗氧化剂与补充药丸抗氧化剂对炎症标志物的抗氧化剂抗氧化剂的抗炎药，并在通常健康的受试者中患有健康的受试者。设计：这是一项随机，单盲（饮食）/双盲（补充），平行，可行性研究。 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食品）八周。数据将在基线，四个和八周内收集。主要的研究结果是炎症的标志物，包括C反应蛋白，纤维蛋白原，IL-6，TNF-Alpha和可溶性ICAM-1。次要结果包括肱动脉和尿异前列腺的流动介导的血管舒张。含义：这项研究旨在评估动脉粥样硬化对抗氧化剂干预措施的新颖标志物的反应性。炎症标志物和内皮功能的测试可能会提供一种快速可靠的方法，以低成本评估抗氧化剂干预措施的临床结果，并允许微调最佳组合，来源和剂量的抗氧化剂，以进行未来的较长期限和大规模研究。