Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2006-05-31
2007-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Diet (Anti-Inflammatory or standard diabetic diet)
6 weeks standard ADA diet, then randomized to either ADA or antiinflammatory (AI) diet for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* Age 18-75 yrs
* Diagnosed with type 2 diabetes or pre-diabetes
* At risk for type 2 diabetes. Must meet 2 of the following 3 criteria: BMI 30-45 kg/m2, age 50 or older, and/or family history of type 2 diabetes
* Fasting blood glucose of 100-200 mg/dl
* Provide informed consent
Exclusion Criteria
* Taking diabetic medication other than sulfonylurea
* Taking Gymnema silvestra (a naturopathic diabetes treatment)
* Taking medications that have anti-inflammatory affects (lipid lowering agents, NSAIDS, COX 2 inhibitors, aspirin, HRT, oral contraceptives, testosterone, seizure medications)
* Taking weight loss medications
* Severe renal, hepatic, or heart disease
* Triglycerides \>500 mg/dL
* Bulimia
* Pregnancy or lactation
* Current excessive use of alcohol
* Current/recent chronic use of recreational drugs
* Smoker
* More than 4 hours/week of aerobic exercise
* Have gained or lost more than 15 pounds during previous 6 months
* Planning on moving out of the area in the next 4 months
* Is a participant in another medical research study
* Is following a weight loss diet
* Is unwilling to accept random assignment of the experimental diets
* Food preferences and/or allergies that will interfere with consumption of experimental diet
18 Years
75 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
National University of Natural Medicine
OTHER
Responsible Party
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Helfgott Research Institute
Principal Investigators
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Patricia Elmer, PhD
Role: PRINCIPAL_INVESTIGATOR
National College of Naturopathic Medicine
Locations
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Oregon Health & Science University General Clinical Research Center
Portland, Oregon, United States
Countries
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Other Identifiers
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