NCT03202680

Lean Beef Consumption and Insulin Sensitivity in Men and Women With Risk Factors for Diabetes

A Randomized, Controlled-Feeding, Crossover Trial to Assess the Effects of Increasing Lean Beef Consumption Within a Healthy Dietary Pattern on Insulin Sensitivity in Men and Women With Risk Factors for Diabetes Mellitus.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Midwest Center for Metabolic and Cardiovascular Research · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to compare the effects of a healthy, lean beef diet and an average American, United States Department of Agriculture (USDA) style diet, that is low in saturated fatty acids (SFA), on insulin sensitivity in men and women with risk factors for diabetes mellitus.

Detailed description

This is a randomized, controlled, crossover study that includes two screening visits, one baseline visit, two 28-d test periods and an end-of-washout visit. A 2-week washout period will separate the two treatments. Subjects will be screened to identify metabolic syndrome and/or prediabetes at the screening visits. Eligible subjects will be randomly assigned to a test sequence (USDA/lean beef or lean beef/USDA diets) and the appropriate calorie menu within each test diet, which will be determined based on each subject's calculated energy needs for weight maintenance. Study foods will be dispensed, and subjects will be instructed to consume all of the foods in their entirety for the duration of each 28-d test period, and avoid consuming any additional food or drink items that has not been provided to them. Compliance will be assessed through a Food Deviation Log where subjects will record any non-study food/beverages consumed, and any portions of the study foods not consumed. An intravenous glucose tolerance test (IVGTT) will be completed at baseline and the end of each treatment period, and fasting glucose and insulin will also be measured at screening and at the first test visit in each treatment period. Fasting blood samples will be collected for lipid profile and high-sensitivity C-reactive protein (hs-CRP) measurements at all treatment visits. Additionally, fasting blood will be drawn for measurement of apolipoprotein B and A1 and lipoprotein particles and subfractions at baseline and the end of each treatment period. Assessments of vital signs, body weight, evaluation of inclusion and exclusion criteria, medication/supplement use, and adverse effects will be performed throughout the study.

Conditions

• Metabolic Syndrome
• PreDiabetes

Interventions

Type	Name	Description
OTHER	USDA Style Diet	USDA style healthy diet, low in saturated fats.
OTHER	Lean Beef Diet	A lean beef containing healthy diet, low in saturated fats.

Timeline

• Start date: 2017-07-06
• Primary completion: 2018-07-16
• Completion: 2019-07-16
• First posted: 2017-06-28
• Last updated: 2019-07-24

Locations

1 site across 1 country: United States