Clinical Trials Directory

Trials / Completed

CompletedNCT01222429

Practice Based Nutrition Intervention

Practice-Based Nutrition Intervention

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Physicians Committee for Responsible Medicine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study aims to test a dietary intervention for diabetes in a medical practice setting, with the aim of developing a model for diabetes care that can be used widely. The investigators hypothesize that a low-fat vegan diet will be effective for management of diabetes and will be feasible in a practice-based setting.

Detailed description

Specific Aim 1 tests the hypothesis that the nutrition intervention (low fat, low-GI vegan diet) improves glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in a within-group analysis. Specific Aim 2 tests the hypothesis that the nutrition intervention (low fat, low-GI vegan diet) is more effective than standard nutrition care for improving glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in individuals with type 2 diabetes Specific Aim 3 tests the hypothesis that a low-fat vegan diet is sustainable among individuals with type 2 diabetes for a 20-week period, with weekly classes, and in a follow-up period of one year with limited professional support. Specific Aim 4 tests the hypothesis that a low-fat vegan diet has an acceptability that is comparable to that of standard nutrition care among individuals with type 2 diabetes. Specific Aim 5 tests the hypothesis that the effects of the dietary interventions on A1c and body weight are reduced in individuals with the A1 allele of the Taq1A and Taq1B polymorphism

Conditions

Interventions

TypeNameDescription
OTHERvegan dietIntervention group participants will follow a low-fat vegan diet and will receive instruction on this diet through the course of the study
OTHERdiet following ADA guidelinesparticipants will be given instruction on the ADA guidelines for diabetes, and will follow an individualized plan based on these guidelines

Timeline

Start date
2010-10-01
Primary completion
2011-06-01
Completion
2012-02-01
First posted
2010-10-18
Last updated
2012-08-07

Source: ClinicalTrials.gov record NCT01222429. Inclusion in this directory is not an endorsement.