Plant-Based Dietary Intervention in Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 99
- Locations
- 2
- Primary Endpoint
- Hemoglobin A1c
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Hemoglobin A1c
Time Frame: 22 weeks
Secondary Outcomes
- Body weight(22 weeks)
- Plasma lipid concentrations(22 weeks)
- Urinary albumin(22 weeks)
- Dietary Acceptability(22 weeks)