Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03202654
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2017-06-26
Brief Title:
Effects of Corn and Coconut Oils on Lipoprotein Lipids Insulin Sensitivity and Inflammation
Sponsor:
Midwest Center for Metabolic and Cardiovascular Research
Organization:
Midwest Center for Metabolic and Cardiovascular Research
Study Overview
Official Title:
A Randomized Double-Blind Controlled Crossover Pilot Trial Comparing the Effects of Corn and Coconut Oils on Fasting Lipoprotein Lipids and Markers of Insulin Sensitivity and Inflammation in Men and Women
Status:
COMPLETED
Status Verified Date:
2018-05
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 objectives of this trial are to assess the effects of corn oil and coconut oil on low-density lipoprotein cholesterol LDL-C concentrations and other aspects of the fasting lipoprotein lipid profile as well as insulin sensitivity and an inflammatory marker in men and women
Detailed Description:
This is a randomized crossover pilot study that includes two screening visits and two 4-week test periods separated by a 3-week washout Subjects will consume study products providing 4 tablespoons oilday of either corn oil or coconut oil replacing the same amount of oil in the background diet Subjects will otherwise be encouraged to follow their habitual diet during both treatment periods They will receive diet instructions on the incorporation of food substitutions during the test periods to maintain habitual energy intake Subjects will record daily study product intake and compliance in a Daily Log An intravenous glucose tolerance test IVGTT will be completed at baseline and the end of each treatment period for evaluation of insulin sensitivity Fasting blood samples will be collected for lipid profile and high-sensitivity C-reactive protein hs-CRP measurements at all visits Assessments of vital signs and body weight review of concomitant medicationsupplement use and inclusion and exclusion criteria for relevant changes and evaluation of adverse effects will be performed throughout the study Compliance will be assessed using the Daily Log intake percentages as the primary source
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