Practice Based Nutrition Intervention

Practice-Based Nutrition Intervention

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: diet following ADA guidelines; Other: vegan diet

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥126 mg/dl on 2 occasions or a prior physician's diagnosis of type 2 diabetes with the use of hypoglycemic medications for at least 6 months
2. male or female
3. A1c between 6.5% and 10.5%
4. age at least 18 years
5. ability and willingness to participate in all components of the study
6. willingness to be assigned to either a low-fat, vegan diet or to standard nutrition care
7. diabetes medications unchanged for 1 month prior to volunteering for the study
8. patient of Dr. Mark Sklar

Exclusion Criteria:

1. body mass index >45 kg/m2
2. alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
3. use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
4. pregnancy or plans to become pregnant
5. history of severe mental illness (with current unstable status)
6. likely to be disruptive in group sessions (as determined by research staff)
7. Signs/symptoms of acute uncontrolled diabetes (including but not limited to polyuria, polydipsia, blurred vision, uncontrolled weight loss)
8. unstable medical status
9. already following a low-fat, vegetarian diet
10. an inordinate fear of blood draws
11. inability to maintain current medication regimen
12. lack of English fluency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: diet following American Diabetes Association guidelines; Participants will follow diets based on ADA guidelines. This group will also receive weekly nutrition classes.	Other: diet following ADA guidelines; participants will be given instruction on the ADA guidelines for diabetes, and will follow an individualized plan based on these guidelines
Experimental: vegan diet; 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; Intervention group participants will follow a low-fat vegan diet and will receive instruction on this diet through the course of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hemoglobin A1C (diabetes management)	assessment at baseline (0 weeks)
hemoglobin A1C (diabetes management)	assessment at 10 weeks
hemoglobin A1C (diabetes management)	assessment at 20 weeks
hemoglobin A1C (diabetes management)	assessment at one-year follow-up
lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)	assessment at baseline (0 weeks)
lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)	assessment at 10 weeks
lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)	assesment at 20 weeks
lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)	assessment at one-year follow-up
body weight	assessment at baseline (0 weeks)
body weight	assessment at 10 weeks
body weight	assessment at 20 weeks
body weight	assessment at one-year follow-up
indices of renal function (serum creatinine, microalbumin)	assessment at baseline (0 weeks)
indices of renal function (serum creatinine, microalbumin)	assessment at 10 weeks
indices of renal function (serum creatinine, microalbumin)	assessment at 20 weeks
indices of renal function (serum creatinine, microalbumin)	assessment at one-year follow-up

Collaborators and Investigators

• Sponsor: Physicians Committee for Responsible Medicine
• Investigators: Principal Investigator: Neal D Barnard, MD, Washington Center for Clinical Research

Publications and helpful links

General Publications

• Barnard ND, Levin SM, Gloede L, Flores R. Turning the Waiting Room into a Classroom: Weekly Classes Using a Vegan or a Portion-Controlled Eating Plan Improve Diabetes Control in a Randomized Translational Study. J Acad Nutr Diet. 2018 Jun;118(6):1072-1079. doi: 10.1016/j.jand.2017.11.017. Epub 2018 Feb 15. Erratum In: J Acad Nutr Diet. 2019 Aug;119(8):1391-1393.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: October 12, 2010
• First Submitted That Met QC Criteria: October 14, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Estimate): August 7, 2012
• Last Update Submitted That Met QC Criteria: August 6, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: PBNI-1