Practice Based Nutrition Intervention-2

NCT01700868 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2015-10-20

No results posted yet for this study

Summary

This study aims to test hypotheses that are potentially important to diabetes management, with practical implications for reducing the medical, personal, and economic costs of the disease. Anticipated outcomes include reductions in glycosylated hemoglobin that are significantly greater than those achievable with current diet recommendations, reductions in medication use among many intervention-group participants, beneficial changes in body weight and serum lipid concentrations, and a demonstration of the acceptability of the intervention diet. Progress toward these goals could refine dietary guidance for individuals with diabetes, increase treatment expectations, and reduce the massive burden the disease currently imposes.

The study further attempts to translate a dietary intervention studied in a clinical research setting to a medical practice. This will contribute to developing a model for diabetes care that can be used widely.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

OTHER

Vegan diet

A diet devoid of any animal products. Low-fat, low-Glycemic Index, vegan diet.

OTHER

American Diabetes Association guidelines

Participants will follow individualized diet plans following ADA guidelines

Sponsors & Collaborators

  • Physicians Committee for Responsible Medicine

    lead OTHER

Principal Investigators

  • Neal Barnard, MD · Physicians Committee for Responsible Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01700868 on ClinicalTrials.gov