NCT00883038

Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Institute for Clinical and Experimental Medicine · Other Government
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the effect of experimental (vegetarian) diet compared to conventional diet with similar caloric restriction on insulin resistance, body weight and body composition in type 2 diabetic patients after 3 month diet program and additional 3 month diet program combined with intensive exercise. Hypothesis: Greater improvement in insulin resistance, greater weight loss without compromising the body composition (subjects will lose fat preferentially to lean body mass) and differences in the fatty tissue metabolism will be found in the experimental (vegetarian) group compared to the control (conventional diet) group despite the similar advise on caloric restriction in both diets. The differences between the two groups will increase after an intensive physical exercise program.

Detailed description

Open randomized study. Individuals with type 2 diabetes (n=60) will be recruited through newspaper advertisements and through advertisements in the hospital. They will be randomly assigned to a low-fat vegetarian diet or a diet following the guidelines of the Study Group on Diabetes and Nutrition of the European Association for the Study of Diabetes (DNSG) (21) with similar caloric restriction (-500 kcal/d). The participants will be followed for 12 weeks and then for another 12 weeks with the addition of intensive physical exercise. All meals during the 6 months will be provided.

Conditions

• Insulin Resistance

Interventions

Type	Name	Description
OTHER	diabetic diet following the DNSG guidelines	The DNSG diet consists of 15-20% protein, ≤7% saturated fat, 60-70% carbohydrate and monounsaturated fats, cholesterol ≤200 mg/day, fiber content 20-30g/day.
OTHER	low-fat vegetarian diet	The low-fat vegetarian diet (\~10% of energy from fat, 15% protein, and 75% carbohydrate, fiber content 40-50 g/day) consists of vegetables, fruits, grains, legumes and small amounts of nuts. Participants will be asked to avoid animal products and added fats and to favor low-glycemic index foods, such as beans and green vegetables.

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-11-01
• Completion: 2009-03-01
• First posted: 2009-04-17
• Last updated: 2009-04-17

Locations

1 site across 1 country: Czechia