RCT of the Naturopathic Anti-Inflammatory Diet

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Clinical Trial of the Naturopathic Anti-Inflammatory Diet

Conditions
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Diabetes Mellitus, Type 2, Prediabetes

Intervention / Treatment
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* Behavioral: Diet (Anti-Inflammatory or standard diabetic diet)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Diet (Anti-Inflammatory or standard diabetic diet)|6 weeks standard ADA diet, then randomized to either ADA or antiinflammatory (AI) diet for 6 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokines |  | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose |  | 113 weeks | 
| Weight |  | 13 weeks | 
| Lipids |  | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Pre-Diabetes, Anti-Inflammatory Diet, Diet Study, Inflammation, Diabetic Diet