Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03202680
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2017-06-26
Brief Title:
Lean Beef Consumption and Insulin Sensitivity in Men and Women With Risk Factors for Diabetes
Sponsor:
Midwest Center for Metabolic and Cardiovascular Research
Organization:
Midwest Center for Metabolic and Cardiovascular Research
Study Overview
Official Title:
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
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor prediabetes at the screening visits Eligible subjects will be randomly assigned to a test sequence USDAlean beef or lean beefUSDA diets and the appropriate calorie menu within each test diet which will be determined based on each subjects 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 foodbeverages 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 medicationsupplement use and adverse effects will be performed throughout the study
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 medicationsupplement use and adverse effects will be performed throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None