Clinical trial NCT00334919: RCT of the Naturopathic Anti-Inflammatory Diet
Official title: Randomized Clinical Trial of the Naturopathic Anti-Inflammatory Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Prediabetes
Keywords: Diabetes
Pre-Diabetes
Anti-Inflammatory Diet
Diet Study
Inflammation
Diabetic Diet
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2006-06-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 diet based on the current American Diabetes Association guidelines.

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 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

Primary outcomes:
measure: Cytokines
timeFrame: 13 weeks
Secondary outcomes:
measure: Glucose
timeFrame: 113 weeks
measure: Weight
timeFrame: 13 weeks
measure: Lipids
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University General Clinical Research Center
state: Oregon
Study officials:
affiliation: National College of Naturopathic Medicine
name: Patricia Elmer, PhD
role: PRINCIPAL_INVESTIGATOR
References: