Status:
COMPLETED
RCT of the Naturopathic Anti-Inflammatory Diet
Lead Sponsor:
National University of Natural Medicine
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Diabetes Mellitus, Type 2
Prediabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 die...
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 naturopa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00334919
Start Date
May 1 2006
End Date
December 1 2007
Last Update
June 24 2010
Active Locations (1)
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1
Oregon Health & Science University General Clinical Research Center
Portland, Oregon, United States, 97239