Practice Based Nutrition Intervention-2 (PBNI-2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01700868|
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : October 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Other: Vegan diet Other: American Diabetes Association guidelines||Not Applicable|
Specific Aim 1 tests the hypothesis that the nutrition intervention (low-fat, low-GI, vegan diet; henceforth called the 'vegan diet') improves glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in a within-group analysis.
Glycosylated hemoglobin is the primary dependent variable, as well as fasting plasma glucose and urinary albumin and creatinine concentrations. The within-group changes in these variables from baseline to week 20, one-year follow-up will be compared.
Specific Aim 2 tests the hypothesis that the 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.
Glycosylated hemoglobin is the primary dependent variable, as well as fasting plasma glucose and urinary albumin and creatinine concentrations in both the intervention and control groups. The between-groups differences in the changes in these variables from baseline to week 20, and one-year follow-up will be compared.
Specific Aim 3 tests the hypothesis that the 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.
This will be assessed by 3-day dietary records at weeks 0, 20 and one-year follow-up.
Specific Aim 4 tests the hypothesis that the vegan diet has an acceptability that is comparable to that of standard nutrition care among individuals with type 2 diabetes.
This hypothesis will be addressed by quantitatively assessing adherence to and acceptability of the intervention and control diets, using the 3-day dietary record, the Food Acceptability Questionnaire, and the Eating Inventory, as described below.
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 and B1 alleles of the DRD2 gene.
This will be assessed through Taq1 A1 and B1 genotype determination at baseline.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Practice Based Nutrition Intervention-2|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Vegan Group
Participants in the intervention group will follow a low-fat, vegan diet for 20 weeks, and will attend nutrition classes in the form of a weekly support group.
Other: Vegan diet
A diet devoid of any animal products. Low-fat, low-Glycemic Index, vegan diet.
Other Name: Plant-based diet
Active Comparator: American Diabetes Association guidelines
Participants will follow ADA diet according to ADA regulations. This group will also receive weekly nutrition classes.
Other: American Diabetes Association guidelines
Participants will follow individualized diet plans following ADA guidelines
Other Name: ADA
- hemoglobin A1C (diabetes management) [ Time Frame: 20 weeks ]
- Body Weight [ Time Frame: 20 Weeks ]
- Blood Pressure [ Time Frame: 20 Weeks ]
- Glucose [ Time Frame: 20 Weeks ]
- Comprehensive Metabolic Panel [ Time Frame: 20 Weeks & one-year follow up ]
- Serum cholesterol and triacylglycerol concentrations [ Time Frame: 20 Weeks ]
- Urinary albumin and creatinine [ Time Frame: 20 Weeks ]
- Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E) [ Time Frame: 20 Weeks ]
- Waist and hip circumference [ Time Frame: 20 Weeks ]
- Dietary Acceptability [ Time Frame: 20 Weeks ]
- 3-day dietary records [ Time Frame: 20 Weeks ]
- International Physical Activity Questionnaire [ Time Frame: 20 Weeks ]
- Food Acceptability Questionnaire [ Time Frame: 20 Weeks ]
- Eating Inventory [ Time Frame: 20 Weeks ]
- CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision) [ Time Frame: 20 Weeks ]
- Beck Depression Inventory II (BDI-II) [ Time Frame: 20 Weeks ]
- Height [ Time Frame: 20 Weeks ]
- 24-Hour Multi-Pass Dietary Recalls [ Time Frame: 20 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700868
|United States, District of Columbia|
|Physicians Committee for Responsible Medicine|
|Washington, District of Columbia, United States, 20016|
|Principal Investigator:||Neal Barnard, MD||Physicians Committee for Responsible Medicine|