Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00508937
Status:
COMPLETED
Last Update Posted:
2020-12-23
First Post:
2007-07-26
Brief Title:
Dietary Protein and Insulin Sensitivity Study
Sponsor:
UCSF Benioff Childrens Hospital Oakland
Organization:
UCSF Benioff Childrens Hospital Oakland
Study Overview
Official Title:
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
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None