Plant-Based Dietary Intervention in Type 2 Diabetes
1 other identifier
interventional
99
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Sep 2003
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 11, 2006
CompletedFirst Posted
Study publicly available on registry
January 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedAugust 7, 2012
August 1, 2012
2.8 years
January 11, 2006
August 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c
22 weeks
Secondary Outcomes (4)
Body weight
22 weeks
Plasma lipid concentrations
22 weeks
Urinary albumin
22 weeks
Dietary Acceptability
22 weeks
Study Arms (2)
1
EXPERIMENTALLow-fat, low-Glycemic Index, vegan diet
2
ACTIVE COMPARATORADA diet
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Type 2 Diabetes Mellitus
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, 20016, United States
Related Publications (9)
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. doi: 10.1006/pmed.1999.0529.
PMID: 10446033BACKGROUNDBarnard 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. doi: 10.1016/j.amjmed.2005.03.039.
PMID: 16164885BACKGROUNDJenkins 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. doi: 10.1093/ajcn/78.3.610S.
PMID: 12936955BACKGROUNDBarnard 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. doi: 10.2337/dc06-0606.
PMID: 16873779RESULTTurner-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. doi: 10.1016/j.jada.2008.07.015.
PMID: 18926128RESULTBarnard 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. doi: 10.1016/j.jada.2008.10.049.
PMID: 19167953RESULTBarnard 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. doi: 10.3945/ajcn.2009.26736H. Epub 2009 Apr 1.
PMID: 19339401RESULTBarnard 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. doi: 10.1016/j.nut.2008.07.012. Epub 2008 Oct 2.
PMID: 18834717RESULTTurner-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. doi: 10.3945/jn.111.140921. Epub 2011 Jun 8.
PMID: 21653575DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neal D Barnard, MD
Physicians Committee for Responsible Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2006
First Posted
January 13, 2006
Study Start
September 1, 2003
Primary Completion
June 1, 2006
Study Completion
July 1, 2006
Last Updated
August 7, 2012
Record last verified: 2012-08