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Completed

NCT Number: NCT00334919

RCT of the Naturopathic Anti-Inflammatory Diet

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oregon Health & Science University General Clinical Research Center

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet (Anti-Inflammatory or standard diabetic diet)

Behavioral

6 weeks standard ADA diet, then randomized to either ADA or antiinflammatory (AI) diet for 6 weeks

Primary outcomes

  1. Cytokines

    Time frame: 13 weeks

Secondary outcomes

  1. Glucose

    Time frame: 113 weeks

  2. Weight

    Time frame: 13 weeks

  3. Lipids

    Time frame: 13 weeks

Sponsors and collaborators

Lead sponsor

National University of Natural Medicine

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Randomized Clinical Trial of the Naturopathic Anti-Inflammatory Diet

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 8, 2006
Registry last updated
Jun 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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