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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
24
4 tablespoons/day of corn oil for 4-week treatment period.
4 tablespoons/day of coconut oil for 4-week treatment period.
MB Clinical Research
Boca Raton, Florida, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Percent change in LDL-C
Percent change in LDL-C from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 2-week and 4-week visits of each test period).
Time frame: Up to 28 days for each treatment period.
Percent change in non-high-density lipoprotein cholesterol (Non-HDL-C).
Percent change in Non-HDL-C from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 2-week and 4-week visits of each test period).
Time frame: Up to 28 days for each treatment period.
Percent change in Total Cholesterol (TC)
Percent change in TC from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 2-week and 4-week visits of each test period).
Time frame: Up to 28 days for each treatment period.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.