NCT00508937

Dietary Protein and Insulin Sensitivity Study

The Effects of Increased Dietary Protein Intake on Insulin Sensitivity in Stable Weight Individuals, Independent of Dietary Content of Carbohydrate and Saturated Fat

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 660 (actual)
• Sponsor: UCSF Benioff Children's Hospital Oakland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Insulin Resistance
• Type 2 Diabetes
• Metabolic Syndrome
• Cardiovascular Disease
• Dyslipidemia

Interventions

Type	Name	Description
OTHER	Diet	15% protein, 55% carbohydrate, 30% fat (7% saturated, 7% polyunsaturated)
OTHER	Diet	20% protein, 35% carbohydrate, 45% fat (7% saturated, 7% polyunsaturated)
OTHER	Diet	20% protein, 35% carbohydrate, 45% fat (15% saturated, 7% polyunsaturated)
OTHER	Diet	30% protein, 35% carbohydrate, 35% fat (7% saturated, 7% polyunsaturated)
OTHER	Diet	30% protein, 35% carbohydrate, 35% fat (15% saturated, 7% polyunsaturated)

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2007-07-30
• Last updated: 2020-12-23

Locations

2 sites across 1 country: United States