Plant-Based Dietary Intervention in Type 2 Diabetes

This study has been completed.

Sponsor:

Collaborators:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Diabetes Action Research and Education Foundation

George Washington University

University of Toronto

Information provided by (Responsible Party):

Physicians Committee for Responsible Medicine

ClinicalTrials.gov Identifier:

NCT00276939

First received: January 11, 2006

Last updated: August 6, 2012

Last verified: August 2012

History of Changes

Purpose

The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 22 weeks with a one-year follow-up.

Condition	Intervention
Diabetes Mellitus, Type 2	Behavioral: Low-fat, low-Glycemic Index, vegan diet

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Plant-Based Dietary Intervention in Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

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

Primary Outcome Measures:

Hemoglobin A1c [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body weight [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
Plasma lipid concentrations [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
Urinary albumin [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
Dietary Acceptability [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]

Enrollment:	99
Study Start Date:	September 2003
Study Completion Date:	July 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Low-fat, low-Glycemic Index, vegan diet	Behavioral: Low-fat, low-Glycemic Index, vegan diet
Active Comparator: 2 ADA diet	Behavioral: Low-fat, low-Glycemic Index, vegan diet

Detailed Description:

Preliminary evidence suggests that low-fat, vegetarian regimens similar to those used to reverse coronary artery blockages may have a significant beneficial effect on type 2 diabetes, as demonstrated by reductions in fasting serum glucose concentrations and medication use. We therefore randomly assigned 99 individuals with type 2 diabetes to either a low-fat, vegan diet or a diet based on current American Diabetes Association guidelines for 22 weeks with a one-year follow-up period. The principal dependent measure is hemoglobin A1c. Cardiovascular risk factors are also being tracked, as is dietary acceptance.

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of Type 2 Diabetes Mellitus

Exclusion Criteria:

hemoglobin A1c values <6.5% or >10.5%
use of insulin for > 5 years
tobacco use within the preceding 6 months
consumption of more than 2 alcoholic beverages per day
current drug abuse
pregnancy
unstable medical status
current use of a low-fat, vegetarian diet.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276939

Locations

United States, District of Columbia
Physicians Committee for Responsible Medicine
Washington, District of Columbia, United States, 20016

Sponsors and Collaborators

Physicians Committee for Responsible Medicine

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Diabetes Action Research and Education Foundation

George Washington University

University of Toronto

Investigators

Principal Investigator:

Neal D Barnard, MD

Physicians Committee for Responsible Medicine

More Information

Publications:

Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83.

Turner-McGrievy GM, Barnard ND, Cohen J, Jenkins DJ, Gloede L, Green AA. Changes in nutrient intake and dietary quality among participants with type 2 diabetes following a low-fat vegan diet or a conventional diabetes diet for 22 weeks. J Am Diet Assoc. 2008 Oct;108(10):1636-45.

Barnard ND, Gloede L, Cohen J, Jenkins DJ, Turner-McGrievy G, Green AA, Ferdowsian H. A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc. 2009 Feb;109(2):263-72.

Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Green A, Ferdowsian H. A low-fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74-wk clinical trial. Am J Clin Nutr. 2009 May;89(5):1588S-1596S. Epub 2009 Apr 1.

Barnard ND, Noble EP, Ritchie T, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Green AA, Ferdowsian H. D2 dopamine receptor Taq1A polymorphism, body weight, and dietary intake in type 2 diabetes. Nutrition. 2009 Jan;25(1):58-65. Epub 2008 Oct 2.

Nicholson AS, Sklar M, Barnard ND, Gore S, Sullivan R, Browning S. Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet. Prev Med. 1999 Aug;29(2):87-91.

Barnard ND, Scialli AR, Turner-McGrievy G, Lanou AJ, Glass J. The effects of a low-fat, plant-based dietary intervention on body weight, metabolism, and insulin sensitivity. Am J Med. 2005 Sep;118(9):991-7.

Jenkins DJ, Kendall CW, Marchie A, Jenkins AL, Augustin LS, Ludwig DS, Barnard ND, Anderson JW. Type 2 diabetes and the vegetarian diet. Am J Clin Nutr. 2003 Sep;78(3 Suppl):610S-616S. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Turner-McGrievy GM, Jenkins DJ, Barnard ND, Cohen J, Gloede L, Green AA. Decreases in dietary glycemic index are related to weight loss among individuals following therapeutic diets for type 2 diabetes. J Nutr. 2011 Aug;141(8):1469-74. Epub 2011 Jun 8.

Responsible Party:	Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier:	NCT00276939 History of Changes
Other Study ID Numbers:	PCRM GWU DM Study
Study First Received:	January 11, 2006
Last Updated:	August 6, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Physicians Committee for Responsible Medicine:

Diabetes Mellitus, Type 2
Diet, Vegetarian
Diet, Fat-Restricted
Glycemic Index

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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