NCT03202654

Effects of Corn and Coconut Oils on Lipoprotein Lipids, Insulin Sensitivity and Inflammation

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Midwest Center for Metabolic and Cardiovascular Research · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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 oil/day 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 medication/supplement 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.

Conditions

• Healthy Men and Women

Interventions

Type	Name	Description
OTHER	Corn Oil	4 tablespoons/day of corn oil for 4-week treatment period.
OTHER	Coconut Oil	4 tablespoons/day of coconut oil for 4-week treatment period.

Timeline

• Start date: 2017-06-22
• Primary completion: 2017-10-10
• Completion: 2017-10-31
• First posted: 2017-06-28
• Last updated: 2018-05-15

Locations

2 sites across 1 country: United States