RCT of the Naturopathic Anti-Inflammatory Diet

June 23, 2010 updated by: National University of Natural Medicine

Randomized Clinical Trial 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University General Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cytokines
Time Frame: 13 weeks
13 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Glucose
Time Frame: 113 weeks
113 weeks
Weight
Time Frame: 13 weeks
13 weeks
Lipids
Time Frame: 13 weeks
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Natural Medicine

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Patricia Elmer, PhD, National College of Naturopathic Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 6, 2006

First Submitted That Met QC Criteria

June 6, 2006

First Posted (Estimate)

June 8, 2006

Study Record Updates

Last Update Posted (Estimate)

June 24, 2010

Last Update Submitted That Met QC Criteria

June 23, 2010

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT002374-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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