NCT01931631

Plant-Based Dietary Intervention in Type 2 Diabetes-2

A Practice-Based, Nutrition Intervention in Type 2 Diabetes

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Physicians Committee for Responsible Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 20 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. The investigators 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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
BEHAVIORAL	Low-fat, low-Glycemic Index, vegan diet	Low-fat, low-Glycemic Index, vegan diet
BEHAVIORAL	ADA diet	Diet in accordance with the American Diabetes Association

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2013-08-29
• Last updated: 2025-07-01

Locations

1 site across 1 country: United States