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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00334919 |
The purpose of this study is to determine if the naturopathic Anti-Inflammatory Diet results in reduced inflammation and a better response by the immune system when compared to a standard diabetic diet based on the current American Diabetes Association guidelines.
Condition | Intervention | Phase |
Diabetes Mellitus, Type 2 Prediabetes |
Behavioral: Diet (Anti-Inflammatory or standard diabetic diet) |
Phase II |
MedlinePlus related topics: | Diabetes Diabetic Diet |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Randomized Clinical Trial of the Naturopathic Anti-Inflammatory Diet |
Estimated Enrollment: | 36 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
This study will test the effects of two different diets on the immune system and inflammation in diabetes and pre-diabetes. These diets are the "Anti-Inflammatory Diet" (AI Diet) used by many naturopathic doctors and a standard diabetic diet based on the American Diabetes Association recommendations (ADA Diet). The AI diet excludes wheat, dairy products, eggs, red meat, caffeine, alcohol, peanuts and certain fruits and vegetables. The ADA diet includes most foods but controls the amount of each of the food groups.
Naturopathic physicians often use healthful diets to treat diseases but many of these diets have not been compared to usual medical diet treatments. We will be looking at blood markers that show how the immune system responds to the different diets. We are expecting that the AI diet will result in less inflammation and a better response by the immune system than the ADA diet. We will also be looking at levels of blood lipids and glucose to see any effects on these risk factors.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heather Schiffke, MATCM | 503-552-1750 | hschiffke@ncnm.edu |
Contact: Angela Horgan, PhD | 503-494-6231 | horgana@ohsu.edu |
United States, Oregon | |||||
Oregon Health & Science University General Clinical Research Center | Recruiting | ||||
Portland, Oregon, United States, 97239 |
Principal Investigator: | Patricia Elmer, PhD | National College of Naturopathic Medicine |
Helfgott Research Institute Study Participation Opportunities 
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Oregon Health & Science University Study Participation Opportunities 
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Responsible Party: | Helfgott Research Institute ( Patricia Elmer, PhD ) |
Study ID Numbers: | R21 AT002374-01A1 |
First Received: | June 6, 2006 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00334919 |
Health Authority: | United States: Federal Government |
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