The overall objective of the Dietary Protein and Insulin Sensitivity Study is to test the hypothesis that increased protein in a diet with reduced carbohydrate (35% energy) can ameliorate insulin resistance in the absence of weight loss, and that this effect is independent of saturated fat content. Moreover, we will test whether such diets result in beneficial changes in total LDL cholesterol, small, dense LDL, and HDL cholesterol that are also independent of saturated fat intake.
Insulin resistance is a major metabolic disturbance associated with excess adiposity that contributes to atherogenic dyslipidemia and predisposes to both cardiovascular disease and type 2 diabetes mellitus. The effects on insulin resistance of changes in dietary macronutrient composition in the absence of weight loss are poorly understood. To better understand these effects, we will study men and women with insulin resistance after 4 weeks on a basal diet (15% protein, 55% carbohydrate, 30% fat) and 4 weeks after random assignment to the basal diet or one of 4 diets with 35% carbohydrate and either 20% or 30% protein, and either 7% or 15% saturated fat. At the end of each dietary period (4 weeks and 8 weeks), we will draw a blood sample for detailed metabolic measurements and measure insulin sensitivity by the frequently sampled intravenous glucose tolerance test (FSIGT) method. In addition to insulin resistance, we will assess the effect of dietary composition on parameters of atherogenic dyslipidemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
660
15% protein, 55% carbohydrate, 30% fat (7% saturated, 7% polyunsaturated)
20% protein, 35% carbohydrate, 45% fat (7% saturated, 7% polyunsaturated)
20% protein, 35% carbohydrate, 45% fat (15% saturated, 7% polyunsaturated)
30% protein, 35% carbohydrate, 35% fat (7% saturated, 7% polyunsaturated)
30% protein, 35% carbohydrate, 35% fat (15% saturated, 7% polyunsaturated)
Cholesterol Research Center
Berkeley, California, United States
San Francisco General Hospital
San Francisco, California, United States
Insulin Sensitivity by Frequently Sampled Intravenous Glucose Tolerance test
Time frame: 4wks and 8wks
Total Cholesterol
Time frame: 4wks and 8wks
LDL Cholesterol
Time frame: 4wks and 8wks
HDL Cholesterol
Time frame: 4wks and 8wks
Triglycerides
Time frame: 4wks and 8wks
LDL peak particle size
Time frame: 4wks and 8wks
LDL subclasses
Time frame: 4wks and 8wks
Apolipoprotein B
Time frame: 4wks and 8wks
Apolipoprotein A1
Time frame: 4wks and 8wks
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