RCT of the Naturopathic Anti-Inflammatory Diet

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Randomized Clinical Trial of the Naturopathic Anti-Inflammatory Diet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334919
• Other study ID #: R21AT002374-01A1
• Secondary ID: R21AT002374-01A1
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2006
• Last updated: June 23, 2010
• Start date: May 2006
• Est. completion date: December 2007

Study information

• Verified date: May 2009
• Source: National College of Natural Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Prediabetes

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health & Science University General Clinical Research Center	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
National College of Natural Medicine	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokines		13 weeks	No
Secondary	Glucose		113 weeks	No
Secondary	Weight		13 weeks	No
Secondary	Lipids		13 weeks	No

External Links

•   Helfgott Research Institute Study Participation Opportunities
•   Oregon Health & Science University Study Participation Opportunities