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Sponsors and Collaborators: |
University of Cincinnati American Diabetes Association |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00622960 |
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.
Condition | Intervention | Phase |
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Overweight Obesity Type 2 Diabetes |
Other: High-MUFA diet Other: High-CHO diet |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Comparison of High Monounsaturated Fat and High Carbohydrate Diets on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes |
Enrollment: | 124 |
Study Start Date: | April 2004 |
Study Completion Date: | April 2007 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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High MUFA diet: Experimental
Those subjects assigned to a high monounsaturated fat diet
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Other: High-MUFA diet
The effects of high monounsaturated fat diet on body weight, body composition, lipid profile, and glycemic control.
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High CHO diet: Active Comparator
Those subjects assigned to a high carbohydrate diet
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Other: High-CHO diet
The effects of high carbohydrate diet on body weight, body composition, lipid profile, and glycemic control.
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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.
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45221 |
Principal Investigator: | Bonnie J Brehm, PhD | University of Cincinnati |
Responsible Party: | University of Cincinnati ( Bonnie J. Brehm ) |
Study ID Numbers: | ADA 1-04-CR-05 |
Study First Received: | February 13, 2008 |
Last Updated: | February 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00622960 |
Health Authority: | United States: Institutional Review Board |
obesity type 2 diabetes weight loss monounsaturated fat diet |
Obesity Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Body Weight Signs and Symptoms |
Diabetes Mellitus, Type 2 Weight Loss Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |