Healthy Men and Women Clinical Trial
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
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01706653 -
The Effects of a Polyphenol-enriched Fruit Drink on Metabolic Health
|
N/A | |
| Completed |
NCT02799498 -
Compare Actions in Healthy Volunteer of 50 mg Etanercept Injection Using an Auto-injector Device and Manual Injection
|
Phase 1 | |
| Completed |
NCT02179931 -
Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)
|
Phase 1 | |
| Completed |
NCT03995602 -
The Effects of Dragon Fruit Consumption on Vascular Function.
|
N/A | |
| Completed |
NCT01643265 -
Effect of Whey and Albumin Protein on Plasma Levels of Amino Acids
|
N/A | |
| Completed |
NCT04095949 -
Absorption, Metabolism and Excretion of Artichoke Polyphenols in Healthy Individuals
|
N/A | |
| Completed |
NCT03553225 -
Randomized, Double-blind, Controlled Study to Evaluate the Effect of Concord Grape Extract on Vascular Function in Healthy Men and Women
|
N/A | |
| Completed |
NCT04276974 -
Effects of an Organic Plant-rich Diet on Gut Microbiome and Vascular Function (ORGAMIC Pilot Study)
|
N/A | |
| Completed |
NCT01836887 -
The Effects of a Polyphenol-enriched Fruit Drink on Metabolic Health(2)
|
N/A | |
| Active, not recruiting |
NCT05058157 -
Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae
|
N/A | |
| Completed |
NCT02588534 -
Open-label Study Using 50 Mg Liquid Etanercept Subcutaneous Injection in the Thigh to Compare an Auto-injector Device and a Manual Injection in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03485716 -
Metabolic Dynamics During Physical Activity
|
N/A |