RCT of the Naturopathic Anti-Inflammatory Diet - Full Text View

Sponsor:	National College of Natural Medicine
Collaborator:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National College of Natural Medicine
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

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetic Diet Diets

U.S. FDA Resources

Further study details as provided by National College of Natural Medicine:

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 ]

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)

Intervention Details:

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

Locations

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

Sponsors and Collaborators

National College of Natural Medicine

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Patricia Elmer, PhD

National College of Naturopathic Medicine

More Information

Additional 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

No publications provided

Responsible Party:	Helfgott Research Institute ( Patricia Elmer, PhD )
Study ID Numbers:	R21 AT002374-01A1, R21AT002374-01A1
Study First Received:	June 6, 2006
Last Updated:	December 11, 2009
ClinicalTrials.gov Identifier:	NCT00334919 History of Changes
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:

Hyperglycemia
Metabolic Diseases
Glucose Intolerance
Diabetes Mellitus, Type 2

Prediabetic State
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010