Dietary Protein and Insulin Sensitivity Study - Full Text View

Sponsored by:	Children's Hospital & Research Center Oakland
Information provided by:	Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:	NCT00508937

Purpose

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.

Condition	Intervention
Insulin Resistance Type 2 Diabetes Metabolic Syndrome Cardiovascular Disease Dyslipidemia	Other: Diet (increased protein intake)

MedlinePlus related topics: Cholesterol Diabetes Dietary Proteins

Drug Information available for: Insulin Dextrose Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Apolipoprotein B [ Time Frame: 4wks and 8wks ]
Apolipoprotein A1 [ Time Frame: 4wks and 8wks ]

Estimated Enrollment:	250
Study Start Date:	February 2007
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
1: Active Comparator Diet: 15% protein, 55% carbohydrate, 30% fat (7% saturated, 7% polyunsaturated)	Other: Diet (increased protein intake)
2: Experimental Diet: 20% protein, 35% carbohydrate, 45% fat (7% saturated, 7% polyunsaturated)	Other: Diet (increased protein intake)
3: Experimental Diet: 20% protein, 35% carbohydrate, 45% fat (15% saturated, 7% polyunsaturated)	Other: Diet (increased protein intake)
4: Experimental Diet: 30% protein, 35% carbohydrate, 35% fat (7% saturated, 7% polyunsaturated)	Other: Diet (increased protein intake)
5: Experimental Diet: 30% protein, 35% carbohydrate, 35% fat (15% saturated, 7% polyunsaturated)	Other: Diet (increased protein 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Body mass index (BMI) ≥ 27 and ≤ 37 kg/m2
HOMA-IR ≥ 2.8 for men and ≥ 2.5 for women
Non-smoking
Total cholesterol and LDL cholesterol <95th percentile for sex and age
Fasting triglycerides < 500mg/dl
Fasting blood sugar < 126
Urinary microalbumin < 30 mg/L
Normal thyroid stimulating hormone levels
Hematocrit ≥ 36%
Blood pressure < 150/90
At least 3 months of a weight-stable state (± 5 lbs) prior to the study. During the study, subjects will be required to maintain their body weight within ± 3% (up to a maximum change of 5 lbs) of their initial weight over the course of any consecutive two weeks after the second week of baseline diet or during the last week of each diet phase

Exclusion Criteria:

History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years
Use of drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent, warfarin
Use of alcohol or dietary supplements during the study
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508937

Contacts

Contact: Ronald M Krauss, M.D.

rkrauss@chori.org

Locations

United States, California
Cholesterol Research Center	Recruiting
Berkeley, California, United States, 94705
Contact 510-665-0501 CRCinfo@chori.org

Sponsors and Collaborators

Children's Hospital & Research Center Oakland

Investigators

Principal Investigator:

Ronald M Krauss, M.D.

Children's Hospital & Research Center Oakland

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	MM3717
Study First Received:	July 26, 2007
Last Updated:	August 1, 2007
ClinicalTrials.gov Identifier:	NCT00508937
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital & Research Center Oakland:

Diet
Protein
Glucose
Insulin

Cholesterol
Triglycerides
LDL subclasses

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Insulin
Body Weight
Hyperinsulinism
Diabetes Mellitus, Type 2

Insulin Resistance
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009