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Dietary Protein and Insulin Sensitivity Study

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ClinicalTrials.gov Identifier: NCT00508937
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : October 5, 2011
Dairy Management Inc.
Information provided by:
Children's Hospital & Research Center Oakland

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.

Condition or disease Intervention/treatment
Insulin Resistance Type 2 Diabetes Metabolic Syndrome Cardiovascular Disease Dyslipidemia Other: Diet

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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
Study Start Date : February 2007
Primary Completion Date : November 2009
Study Completion Date : December 2009

Arm Intervention/treatment
Active Comparator: 1 Other: Diet
15% protein, 55% carbohydrate, 30% fat (7% saturated, 7% polyunsaturated)
Experimental: 2 Other: Diet
20% protein, 35% carbohydrate, 45% fat (7% saturated, 7% polyunsaturated)
Experimental: 3 Other: Diet
20% protein, 35% carbohydrate, 45% fat (15% saturated, 7% polyunsaturated)
Experimental: 4 Other: Diet
30% protein, 35% carbohydrate, 35% fat (7% saturated, 7% polyunsaturated)
Experimental: 5 Other: Diet
30% protein, 35% carbohydrate, 35% fat (15% saturated, 7% polyunsaturated)

Primary Outcome Measures :
  1. Insulin Sensitivity by Frequently Sampled Intravenous Glucose Tolerance test [ Time Frame: 4wks and 8wks ]
  2. Total Cholesterol [ Time Frame: 4wks and 8wks ]
  3. LDL Cholesterol [ Time Frame: 4wks and 8wks ]
  4. HDL Cholesterol [ Time Frame: 4wks and 8wks ]
  5. Triglycerides [ Time Frame: 4wks and 8wks ]
  6. LDL peak particle size [ Time Frame: 4wks and 8wks ]
  7. LDL subclasses [ Time Frame: 4wks and 8wks ]

Secondary Outcome Measures :
  1. Apolipoprotein B [ Time Frame: 4wks and 8wks ]
  2. Apolipoprotein A1 [ Time Frame: 4wks and 8wks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Body mass index (BMI) ≥ 27 and ≤ 40 kg/m2
  • HOMA-IR ≥ 2.5
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508937

United States, California
Cholesterol Research Center
Berkeley, California, United States, 94705
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Dairy Management Inc.
Principal Investigator: Ronald M Krauss, M.D. Children's Hospital & Research Center Oakland

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ronald M. Krauss, M.D., Children's Hospital Oakland Research Institute
ClinicalTrials.gov Identifier: NCT00508937     History of Changes
Other Study ID Numbers: MM3717
First Posted: July 30, 2007    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: October 2011

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Hypoglycemic Agents
Physiological Effects of Drugs