Dietary Protein and Insulin Sensitivity Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Protein Intake & Insulin Action

NCT02004002

Obesity

COMPLETED NA

Animal and Plant Proteins and Glucose Metabolism

NCT03994367

Metabolic Syndrome Metabolic Syndrome, Protection Against Glucose Metabolism Disorders

RECRUITING NA

Daily Protein Pacing Effects on HbA1c in Type 2 Diabetics

NCT05355090

Type 2 Diabetes HbA1c Protein Intake

ACTIVE_NOT_RECRUITING NA

Effect of Different Protein Diets on Glucose and Insulin Metabolism and Substrate Partitioning

NCT01034241

Insulin Glucose Metabolism

COMPLETED NA

Dairy Macronutrient Effects on the Metabolic Syndrome

NCT02885935

Metabolic Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Insulin Resistance Type 2 Diabetes Metabolic Syndrome Cardiovascular Disease Dyslipidemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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