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Dietary Protein and Insulin Sensitivity Study

Primary Purpose

Insulin Resistance, Type 2 Diabetes, Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Diet

About this trial

This is an interventional prevention trial for Insulin Resistance focused on measuring Diet, Protein, Glucose, Insulin, Cholesterol, Triglycerides, LDL subclasses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Cholesterol Research Center
San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Insulin Sensitivity by Frequently Sampled Intravenous Glucose Tolerance test

Total Cholesterol

LDL Cholesterol

HDL Cholesterol

Triglycerides

LDL peak particle size

LDL subclasses

Secondary Outcome Measures

Apolipoprotein B

Apolipoprotein A1

Full Information

NCT ID

NCT00508937

First Posted

July 26, 2007

Last Updated

December 22, 2020

Sponsor

UCSF Benioff Children's Hospital Oakland

Collaborators

Dairy Management Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00508937

Brief Title

Dietary Protein and Insulin Sensitivity 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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UCSF Benioff Children's Hospital Oakland

Collaborators

Dairy Management Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Diet, Protein, Glucose, Insulin, Cholesterol, Triglycerides, LDL subclasses

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

660 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Diet

Intervention Description

15% protein, 55% carbohydrate, 30% fat (7% saturated, 7% polyunsaturated)

Intervention Type

Other

Intervention Name(s)

Diet

Intervention Description

20% protein, 35% carbohydrate, 45% fat (7% saturated, 7% polyunsaturated)

Intervention Type

Other

Intervention Name(s)

Diet

Intervention Description

20% protein, 35% carbohydrate, 45% fat (15% saturated, 7% polyunsaturated)

Intervention Type

Other

Intervention Name(s)

Diet

Intervention Description

30% protein, 35% carbohydrate, 35% fat (7% saturated, 7% polyunsaturated)

Intervention Type

Other

Intervention Name(s)

Diet

Intervention Description

30% protein, 35% carbohydrate, 35% fat (15% saturated, 7% polyunsaturated)

Primary Outcome Measure Information:

Title

Insulin Sensitivity by Frequently Sampled Intravenous Glucose Tolerance test

Time Frame

4wks and 8wks

Title

Total Cholesterol

Time Frame

4wks and 8wks

Title

LDL Cholesterol

Time Frame

4wks and 8wks

Title

HDL Cholesterol

Time Frame

4wks and 8wks

Title

Triglycerides

Time Frame

4wks and 8wks

Title

LDL peak particle size

Time Frame

4wks and 8wks

Title

LDL subclasses

Time Frame

4wks and 8wks

Secondary Outcome Measure Information:

Title

Apolipoprotein B

Time Frame

4wks and 8wks

Title

Apolipoprotein A1

Time Frame

4wks and 8wks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald M Krauss, M.D.

Organizational Affiliation

UCSF Benioff Children's Hospital Oakland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cholesterol Research Center

City

Berkeley

State/Province

California

ZIP/Postal Code

94705

Country

United States

Facility Name

San Francisco General Hospital

City

San Francisco

State/Province

California

ZIP/Postal Code

94110

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25332473

Citation

Chiu S, Williams PT, Dawson T, Bergman RN, Stefanovski D, Watkins SM, Krauss RM. Diets high in protein or saturated fat do not affect insulin sensitivity or plasma concentrations of lipids and lipoproteins in overweight and obese adults. J Nutr. 2014 Nov;144(11):1753-9. doi: 10.3945/jn.114.197624. Epub 2014 Sep 3.

Results Reference

derived

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Dietary Protein and Insulin Sensitivity Study

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