RCT of the Naturopathic Anti-Inflammatory Diet

NCT00334919 | Completed Phase 2 DMC

• 1 other identifier: R21AT002374-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Prediabetes

Keywords

Diabetes; Pre-Diabetes; Anti-Inflammatory Diet; Diet Study; Inflammation; Diabetic Diet

Outcome Measures

Primary Outcomes (1)

• Cytokines

  13 weeks

Secondary Outcomes (3)

• Glucose

  113 weeks

• Weight

  13 weeks

• Lipids

  13 weeks

Interventions

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National University of Natural Medicine: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Oregon Health & Science University General Clinical Research Center

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Diabetes Mellitus; Glucose Intolerance; Inflammation

Interventions

Diet; Anti-Inflammatory Agents

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Patricia Elmer, PhD

  National College of Naturopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2006
• First Posted: June 8, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 24, 2010

Record last verified: 2009-05

Locations

US (1)