Dietary Protein and Insulin Sensitivity Study

NCT ID: NCT00508937

Last Updated: 2020-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-12-31

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.

Conditions

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Diet

Intervention Type: OTHER

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

2

Group Type: EXPERIMENTAL

Diet

Intervention Type: OTHER

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

3

Group Type: EXPERIMENTAL

Diet

Intervention Type: OTHER

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

4

Group Type: EXPERIMENTAL

Diet

Intervention Type: OTHER

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

5

Group Type: EXPERIMENTAL

Diet

Intervention Type: OTHER

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

Interventions

Diet

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

Intervention Type: OTHER

Diet

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

Intervention Type: OTHER

Diet

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

Intervention Type: OTHER

Diet

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

Intervention Type: OTHER

Diet

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dairy Management Inc.

INDUSTRY

Sponsor Role: collaborator

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald M Krauss, M.D.

Role: PRINCIPAL_INVESTIGATOR

UCSF Benioff Children's Hospital Oakland

Locations

Cholesterol Research Center

Berkeley, California, United States

San Francisco General Hospital

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25332473 (View on PubMed)

Other Identifiers

MM3717

Identifier Type: -

Identifier Source: org_study_id