Dietary Protein and Insulin Sensitivity Study

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508937
• Other study ID #: MM3717
• Status: Completed
• Phase: N/A
• Start date: February 2007
• Est. completion date: December 2009

Study information

• Verified date: December 2020
• Source: UCSF Benioff Children's Hospital Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Diet
15% protein, 55% carbohydrate, 30% fat (7% saturated, 7% polyunsaturated)
• Diet
20% protein, 35% carbohydrate, 45% fat (7% saturated, 7% polyunsaturated)
• Diet
20% protein, 35% carbohydrate, 45% fat (15% saturated, 7% polyunsaturated)
• Diet
30% protein, 35% carbohydrate, 35% fat (7% saturated, 7% polyunsaturated)
• Diet
30% protein, 35% carbohydrate, 35% fat (15% saturated, 7% polyunsaturated)

Locations

Country	Name	City	State
United States	Cholesterol Research Center	Berkeley	California
United States	San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
UCSF Benioff Children's Hospital Oakland	Dairy Management Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity by Frequently Sampled Intravenous Glucose Tolerance test		4wks and 8wks
Primary	Total Cholesterol		4wks and 8wks
Primary	LDL Cholesterol		4wks and 8wks
Primary	HDL Cholesterol		4wks and 8wks
Primary	Triglycerides		4wks and 8wks
Primary	LDL peak particle size		4wks and 8wks
Primary	LDL subclasses		4wks and 8wks
Secondary	Apolipoprotein B		4wks and 8wks
Secondary	Apolipoprotein A1		4wks and 8wks