Plant-Based Dietary Intervention in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Plant-Based Dietary Intervention in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276939
• Other study ID #: PCRM GWU DM Study
• Status: Completed
• Phase: N/A
• First received: January 11, 2006
• Last updated: August 6, 2012
• Start date: September 2003
• Est. completion date: July 2006

Study information

• Verified date: August 2012
• Source: Physicians Committee for Responsible Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Low-fat, low-Glycemic Index, vegan diet

Locations

Country	Name	City	State
United States	Physicians Committee for Responsible Medicine	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine	Diabetes Action Research and Education Foundation, George Washington University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Toronto

Country where clinical trial is conducted

United States, 

References & Publications (8)

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): — View Citation

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. Diabet — View Citation

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 indiv — View Citation

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. doi: 10.1016/j.nut.200 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c		22 weeks	No
Secondary	Body weight		22 weeks	No
Secondary	Plasma lipid concentrations		22 weeks	No
Secondary	Urinary albumin		22 weeks	No
Secondary	Dietary Acceptability		22 weeks	No