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RCT of the Naturopathic Anti-Inflammatory Diet

This study is currently recruiting participants.
Verified by National Center for Complementary and Alternative Medicine (NCCAM), May 2008

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
  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 II

MedlinePlus related topics:   Diabetes    Diabetic Diet   

U.S. FDA Resources

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

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Cytokines [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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)

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
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.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334919

Contacts
Contact: Heather Schiffke, MATCM     503-552-1750     hschiffke@ncnm.edu    
Contact: Angela Horgan, PhD     503-494-6231     horgana@ohsu.edu    

Locations
United States, Oregon
Oregon Health & Science University General Clinical Research Center     Recruiting
      Portland, Oregon, United States, 97239

Sponsors and Collaborators

Investigators
Principal Investigator:     Patricia Elmer, PhD     National College of Naturopathic Medicine    
  More Information


Helfgott Research Institute Study Participation Opportunities  This link exits the ClinicalTrials.gov site
 
Oregon Health & Science University Study Participation Opportunities  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Diabetes  
Pre-Diabetes  
Anti-Inflammatory Diet  
Diet Study
Inflammation
Diabetic Diet

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Prediabetic State
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Inflammation

ClinicalTrials.gov processed this record on October 14, 2008




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