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Practice Based Nutrition Intervention-2 (PBNI-2)

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier:
NCT01700868
First received: October 2, 2012
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes
Lipid Panel
Body Weight
Changes in Mood
 Other: Vegan diet
Other: American Diabetes Association guidelines

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: Practice Based Nutrition Intervention-2

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Physicians Committee for Responsible Medicine:

Primary Outcome Measures:
  • hemoglobin A1C (diabetes management) [ Time Frame: assessment at baseline (0 weeks) ] [ Designated as safety issue: No ]
  • hemoglobin A1C (diabetes management) [ Time Frame: assessment at 10 weeks ] [ Designated as safety issue: No ]
  • hemoglobin A1C (diabetes management) [ Time Frame: assessment at 20 weeks ] [ Designated as safety issue: No ]
  • lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) [ Time Frame: assessment at baseline (0 weeks) ] [ Designated as safety issue: No ]
  • lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) [ Time Frame: assessment at 10 weeks ] [ Designated as safety issue: No ]
  • lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) [ Time Frame: assesment at 20 weeks ] [ Designated as safety issue: No ]
  • lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) [ Time Frame: assessment at one-year follow-up ] [ Designated as safety issue: No ]
  • body weight [ Time Frame: assessment at baseline (0 weeks) ] [ Designated as safety issue: No ]
  • body weight [ Time Frame: assessment at baseline (10 weeks) ] [ Designated as safety issue: No ]
  • body weight [ Time Frame: assessment at 20 weeks ] [ Designated as safety issue: No ]
  • body weight [ Time Frame: assessment at one-year follow-up ] [ Designated as safety issue: No ]
  • indices of renal function (serum creatinine, microalbumin) [ Time Frame: assessment at baseline (0 weeks) ] [ Designated as safety issue: No ]
  • indices of renal function (serum creatinine, microalbumin) [ Time Frame: assessment at 10 weeks ] [ Designated as safety issue: No ]
  • indices of renal function (serum creatinine, microalbumin) [ Time Frame: assessment at 20 weeks ] [ Designated as safety issue: No ]
  • indices of renal function (serum creatinine, microalbumin) [ Time Frame: assessment at one-year follow-up ] [ Designated as safety issue: No ]
  • Improvement in mood using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II) [ Time Frame: assessment at 0 weeks ] [ Designated as safety issue: No ]
  • Improvement in mood using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II) [ Time Frame: assessment at 10 weeks ] [ Designated as safety issue: No ]
  • Improvement in mood using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II) [ Time Frame: Assessments at 20 weeks ] [ Designated as safety issue: No ]
  • Improvement in mood using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II) [ Time Frame: assessment at one-year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: September 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Plant-based diet
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: American Diabetes Association guidelines
Other Name: ADA

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

Specific Aim 6 tests the hypothesis that the vegan diet is more effective than standard nutrition care for improving mood, using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • male or female
  • A1c between 6.5% and 10.5%
  • age at least 18 years
  • ability and willingness to participate in all components of the study
  • willingness to be assigned to either a low-fat, vegan diet or to standard nutrition care
  • diabetes medications unchanged for 1 month prior to volunteering for the study
  • patient of Dr. Mark Sklar

Exclusion Criteria:

  • body mass index >45 kg/m2
  • 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
  • use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
  • pregnancy or plans to become pregnant
  • history of severe mental illness (with current unstable status)
  • likely to be disruptive in group sessions (as determined by research staff)
  • Signs/symptoms of acute uncontrolled diabetes (including but not limited to polyuria, polydipsia, blurred vision, uncontrolled weight loss)
  • unstable medical status
  • already following a low-fat, vegetarian diet
  • an inordinate fear of blood draws
  • inability to maintain current medication regimen
  • lack of English fluency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700868

Sponsors and Collaborators
Physicians Committee for Responsible Medicine
Investigators
Principal Investigator: Neal Barnard, MD PCRM
  More Information

No publications provided

Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT01700868     History of Changes
Other Study ID Numbers: PBNI-2
Study First Received: October 2, 2012
Last Updated: December 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013