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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Low-fat, low-Glycemic Index, vegan diet
Diet in accordance with the American Diabetes Association
Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, United States
Hemoglobin A1c
Time frame: 20 weeks
Body Weight
Time frame: 20 Weeks
Blood Pressure
Time frame: 20 Weeks
Glucose
Time frame: 20 Weeks
Comprehensive Metabolic Panel
Time frame: 20 Weeks & one-year follow up
Serum cholesterol and triacylglycerol concentrations
Time frame: 20 Weeks
Urinary albumin and creatinine
Time frame: 20 Weeks
Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E)
Time frame: 20 Weeks
Waist and hip circumference
Time frame: 20 Weeks
Dietary Acceptability
Time frame: 20 Weeks
3-day dietary records
Time frame: 20 Weeks
International Physical Activity Questionnaire
Time frame: 20 Weeks
Food Acceptability Questionnaire
Time frame: 20 Weeks
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Eating Inventory
Time frame: 20 Weeks
CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision)
Time frame: 20 Weeks
Beck Depression Inventory II (BDI-II)
Time frame: 20 Weeks