Plant-Based Dietary Intervention in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Low-fat, low-Glycemic Index, vegan diet

• Registration Number: NCT00276939
• Lead Sponsor: Physicians Committee for Responsible Medicine

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.

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-13
• Primary Completion: 2006-06
• Study Completion: 2006-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-06
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Low-fat, low-Glycemic Index, vegan diet	Low-fat, low-Glycemic Index, vegan diet
2	Low-fat, low-Glycemic Index, vegan diet	ADA diet

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	22 weeks

Secondary Outcome Measures

Name	Time	Method
Body weight	22 weeks
Plasma lipid concentrations	22 weeks
Urinary albumin	22 weeks
Dietary Acceptability	22 weeks

Trial Locations

Locations (1)

Physicians Committee for Responsible Medicine; 🇺🇸 Washington, District of Columbia, United States