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RCT of the Naturopathic Anti-Inflammatory Diet

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ClinicalTrials.gov Identifier: NCT00334919
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : June 24, 2010
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by:
National University of Natural Medicine

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Prediabetes Behavioral: Diet (Anti-Inflammatory or standard diabetic diet) Phase 2

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of the Naturopathic Anti-Inflammatory Diet
Study Start Date : May 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007
Arms and Interventions
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. Cytokines [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. Glucose [ Time Frame: 113 weeks ]
  2. Weight [ Time Frame: 13 weeks ]
  3. Lipids [ Time Frame: 13 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334919


Locations
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United States, Oregon
Oregon Health & Science University General Clinical Research Center
Portland, Oregon, United States, 97239
Sponsors and Collaborators
National University of Natural Medicine
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Patricia Elmer, PhD National College of Naturopathic Medicine
More Information
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Responsible Party: Patricia Elmer, PhD, Helfgott Research Institute
ClinicalTrials.gov Identifier: NCT00334919     History of Changes
Other Study ID Numbers: R21AT002374-01A1 ( U.S. NIH Grant/Contract )
R21AT002374-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: June 24, 2010
Last Verified: May 2009

Keywords provided by National University of Natural Medicine:
Diabetes
Pre-Diabetes
Anti-Inflammatory Diet
 Diet Study
Inflammation
Diabetic Diet

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Anti-Inflammatory Agents