Effect of High Monounsaturated Fat Diet on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes
The purpose of this proposed randomized, controlled trial is to compare the effects of high monounsaturated fat diets and high carbohydrate diets on body weight, body composition, glycemic control, plasma lipids, and other cardiovascular risk factors over a period of one year. At present, no such studies of free-living subjects have been performed. The specific aims of the proposed project are to test the hypotheses that (1) a high monounsaturated fat diet will produce greater weight loss/body fat loss and more successful weight maintenance than a high carbohydrate diet and (2) a high monounsaturated fat diet will result in an improved lipid profile and better glycemic control than a high carbohydrate diet.
Type 2 Diabetes
Other: High-MUFA diet
Other: High-CHO diet
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Comparison of High Monounsaturated Fat and High Carbohydrate Diets on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes|
- body weight [ Time Frame: prior to and after 4, 8, and 12 months of dieting ] [ Designated as safety issue: No ]
- body fat [ Time Frame: prior to and after 4, 8, and 12 months of dieting ] [ Designated as safety issue: No ]
- blood pressure [ Time Frame: prior to and after 4, 8, and 12 months of dieting ] [ Designated as safety issue: No ]
- blood lipid profile [ Time Frame: prior to and after 4, 8, and 12 months of dieting ] [ Designated as safety issue: No ]
- glycemic control (glucose, insulin, and HbA1c) [ Time Frame: prior to and after 4, 8, and 12 months of dieting ] [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Experimental: High MUFA diet
Those subjects assigned to a high monounsaturated fat diet
Other: High-MUFA diet
The effects of high monounsaturated fat diet on body weight, body composition, lipid profile, and glycemic control.
Active Comparator: High CHO diet
Those subjects assigned to a high carbohydrate diet
Other: High-CHO diet
The effects of high carbohydrate diet on body weight, body composition, lipid profile, and glycemic control.
The incidence of type 2 diabetes has increased steadily over the last three decades. Although medical nutrition therapy is an integral component of diabetes management, nutrition recommendations for diabetes have often been based on clinical experience and expert consensus, rather than on carefully controlled clinical trials. The expert consensus on medical nutrition therapy is that carbohydrate and monounsaturated fat together should provide approximately 60-70% of total energy intake. This recommendation accommodates parties on both sides of a debate over what constitutes the optimal macronutrient composition of a diet for type 2 diabetic patients. On one side are proponents of high carbohydrate, low fat diets who contend that this regimen promotes the lowering of total- and LDL-cholesterol and is less calorically dense than diets containing a higher percentage of fat. On the other side are advocates of high monounsaturated fat, Mediterranean-type diets who cite data from short-term studies indicating that this approach decreases postprandial levels of plasma glucose, insulin, and triglycerides, and increases HDL-cholesterol more than isocaloric high carbohydrate diets. However, there is concern about the potential for high fat diets to increase energy intake and weight gain among free-living subjects. To make definitive, scientifically-based diet recommendations, it is essential that controlled long-term trials be conducted to demonstrate the health effects of specific percentages of monounsaturated fats and carbohydrates in the diets of persons with type 2 diabetes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622960
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45221|
|Principal Investigator:||Bonnie J Brehm, PhD||University of Cincinnati|