RCT of the Naturopathic Anti-Inflammatory Diet
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Clinical Trial of the Naturopathic Anti-Inflammatory Diet |
- Cytokines [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
- Glucose [ Time Frame: 113 weeks ] [ Designated as safety issue: No ]
- Weight [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
- Lipids [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | May 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
-
Behavioral: Diet (Anti-Inflammatory or standard diabetic diet)
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- BMI: 25-45 kg/m2
- 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:
- Current major debilitating mental or physical illness that would interfere with participation (as determined by the participant's medical history)
- 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
Contacts and Locations| United States, Oregon | |
| Oregon Health & Science University General Clinical Research Center | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | Patricia Elmer, PhD | National College of Naturopathic Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Patricia Elmer, PhD, Helfgott Research Institute |
| ClinicalTrials.gov Identifier: | NCT00334919 History of Changes |
| Other Study ID Numbers: | R21 AT002374-01A1, R21AT002374-01A1 |
| Study First Received: | June 6, 2006 |
| Last Updated: | June 23, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National College of Natural Medicine:
|
Diabetes Pre-Diabetes Anti-Inflammatory Diet |
Diet Study Inflammation Diabetic Diet |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Intolerance Prediabetic State Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Hyperglycemia Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 16, 2012
