RCT of the Naturopathic Anti-Inflammatory Diet

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 2, Prediabetes

In brief

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.

Key facts

Study ID

NCT00334919

Run by

National University of Natural Medicine

People needed

30

Starts

2006-05-01

Expected to finish

2007-12-01

Last updated by the study team

2010-06-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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