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RCT of the Naturopathic Anti-Inflammatory Diet

Primary Purpose

Diabetes Mellitus, Type 2, Prediabetes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diet (Anti-Inflammatory or standard diabetic diet)
Sponsored by
National University of Natural Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Pre-Diabetes, Anti-Inflammatory Diet, Diet Study, Inflammation, Diabetic Diet

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health & Science University General Clinical Research Center

Outcomes

Primary Outcome Measures

Cytokines

Secondary Outcome Measures

Glucose
Weight
Lipids

Full Information

First Posted
June 6, 2006
Last Updated
June 23, 2010
Sponsor
National University of Natural Medicine
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00334919
Brief Title
RCT of the Naturopathic Anti-Inflammatory Diet
Official Title
Randomized Clinical Trial of the Naturopathic Anti-Inflammatory Diet
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National University of Natural Medicine
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Prediabetes
Keywords
Diabetes, Pre-Diabetes, Anti-Inflammatory Diet, Diet Study, Inflammation, Diabetic Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Diet (Anti-Inflammatory or standard diabetic diet)
Intervention Description
6 weeks standard ADA diet, then randomized to either ADA or antiinflammatory (AI) diet for 6 weeks
Primary Outcome Measure Information:
Title
Cytokines
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Glucose
Time Frame
113 weeks
Title
Weight
Time Frame
13 weeks
Title
Lipids
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Elmer, PhD
Organizational Affiliation
National College of Naturopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University General Clinical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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RCT of the Naturopathic Anti-Inflammatory Diet

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