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Abstract
Grant Number: 1R21AT002374-01A1 Project Title: RCT of the Naturopathic Anti-inflammatory Diet
PI Information: Name Title ELMER, PATRICIA J. elmerpa@earthlink.net SENIOR INVESTIGATOR AND PROFESSOR Abstract: 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.
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Institution: HELFGOTT RESEARCH INSTITUTE 049 SW PORTER ST PORTLAND, OR 972014848 Fiscal Year: 2005 Department: Project Start: 30-SEP-2005 Project End: 31-AUG-2008 ICD: NATIONAL CENTER FOR COMPLEMENTARY & ALTERNATIVE MEDICINE IRG: ZAT1