RCT of the Naturopathic Anti-inflammatory Diet

自然疗法抗炎饮食的随机对照试验

• 批准号: 7140057
• 负责人: PATRICIA J. ELMER
• 金额: $ 17.82万
• 依托单位: NATIONAL UNIVERSITY OF NATURAL MEDICINE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7140057
• 关键词: RCT; Naturopathic; Anti; inflammatory; Diet

DESCRIPTION (provided by applicant): Naturopathic physicians routinely recommend therapeutic diets as part of their medical practice. The "anti-inflammatory"(AI) diet is frequently used and recommended to treat a variety of conditions classified by naturopathic physicians as "inflammatory. This diet excludes dairy products, wheat and gluten, citrus, nightshade vegetables, and meat. While the diet is included in naturopathic medicine texts and is taught in all naturopathic medical schools, and widely also used in other CAM treatments, its efficacy for altering inflammatory markers, for modulation of the immune system or effects on disease outcomes have not been evaluated. Obesity and diabetes have well-characterized abnormalities in their inflammatory markers, including elevated hs-CRP, interleukins, and TNFalpha The objectives of this study are to assess feasibility of testing the Al Diet in a controlled setting (including participant accrual, acceptance of the diet, adherence to the diet and study protocol and safety procedures) and to obtain preliminary data for use in preparation of a larger randomized trial to test the effects of this CAM diet treatment (including information on variability of biologic measures for use in sample size determinations) Goals of this pilot project are 1) to establish clinical methodology for studying the Al diet 2) to evaluate the effect of the Al diet on markers of inflammation and obesity. Thirty-six participants with newly diagnosed type 2 diabetes will be recruited for an 8-week study with four weeks of controlled feeding and four weeks of an at-home diet phase. Controlled feeding diets will be prepared by the OHSU GCRC. After screening, all participants will begin controlled feeding (all foods and beverages are prepared by the study) for two weeks of the American Diabetes Diet (ADA). They will then be randomized to two weeks of controlled feeding of either the ADA diet or the anti-inflammatory diet (Al). Controlled feeding diets are isocaloric intake, designed to maintain stable body weight. The at-home diet phase includes counseling, materials and food samples to assist with following these diets at home for four weeks. Measures include the inflammatory markers TNFalpha, ILbeta, IL-6, and hs-CRP. Others are adiponectin, leptin, insulin, glucose, and fasting lipids. This study will provide us with the first step in evaluating the effects of the anti-inflammatory diet on inflammatory markers and fasting glucose and insulin, independent of dietary fiber content or weight loss; this latter outcome will be important to control initially since weight loss per se affects many inflammatory markers. The detailed sample collection in our study will provide insight as to the time course and nature of the changes in biomarkers, and the variability of these measures over time. Data from this pilot study will be used to design studies that prospectively evaluate the effects of CAM dietary treatments on biological parameters and disease outcomes.

描述（由申请人提供）： 自然疗法医生通常会推荐治疗性饮食作为其医疗实践的一部分。 “抗炎”（AI）饮食经常被使用并推荐用于治疗自然疗法医生归类为“炎症”的各种病症。这种饮食不包括乳制品、小麦和麸质、柑橘、茄属蔬菜和肉类。被纳入自然疗法医学教科书中，并在所有自然疗法医学院教授，​​并且还广泛用于其他 CAM 治疗，其改变炎症标志物、调节免疫系统或对疾病结果的影响的功效已被证实。没有被评估。 肥胖和糖尿病的炎症标志物具有明显的异常特征，包括 hs-CRP、白细胞介素和 TNFα 升高。本研究的目的是评估在受控环境中测试 Al 饮食的可行性（包括参与者应计情况、饮食接受程度） ，遵守饮食和研究方案以及安全程序）并获得初步数据，用于准备更大的随机试验，以测试该 CAM 饮食治疗的效果（包括用于样本量的生物措施变异性的信息）该试点项目的目标是 1) 建立研究铝饮食的临床方法 2) 评估铝饮食对炎症和肥胖标志物的影响。将招募 36 名新诊断为 2 型糖尿病的参与者进行为期 8 周的研究，其中包括 4 周的控制喂养和 4 周的家庭饮食阶段。控制喂养饮食将由 OHSU GCRC 准备。筛选后，所有参与者将开始为期两周的美国糖尿病饮食 (ADA) 控制喂养（所有食物和饮料均由研究准备）。然后，他们将被随机分为两周的 ADA 饮食或抗炎饮食 (Al) 控制喂养。控制喂养饮食是等热量摄入，旨在维持稳定的体重。家庭饮食阶段包括咨询、材料和食物样本，以协助在家遵循这些饮食四个星期。测量指标包括炎症标志物 TNFα、ILβ、IL-6 和 hs-CRP。其他还有脂联素、瘦素、胰岛素、葡萄糖和空腹血脂。这项研究将为我们评估抗炎饮食对炎症标志物以及空腹血糖和胰岛素的影响提供第一步，而与膳食纤维含量或体重减轻无关；后一种结果对于最初的控制很重要，因为体重减轻本身会影响许多炎症标志物。我们研究中详细的样本收集将提供有关生物标志物变化的时间进程和性质以及这些指标随时间变化的见解。该试点研究的数据将用于设计研究，前瞻性评估 CAM 饮食治疗对生物参数和疾病结果的影响。