Clinical Trials Directory

Trials / Terminated

TerminatedNCT02737293

Whole Egg Intake and the Mediterranean Diet

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
33 (actual)
Sponsor
USDA Grand Forks Human Nutrition Research Center · Federal
Sex
All
Age
20 Years – 75 Years
Healthy volunteers
Accepted

Summary

This project will evaluate the daily intake of whole eggs in the Mediterranean Diet (Med Diet). Cholesterol levels are normally related to cardiovascular disease (CVD) risk. Dietary fat and the total diet makeup are well known modifiers of CVD risk. The Med Diet has been shown to decrease blood lipids (fats) and reduce inflammation. Cholesterol intake from eggs may not be as bad as once thought and, in fact, may help to improve the blood lipid (fat) levels. This study is being done to test how the addition of eggs to a Med Diet affects blood lipids and other risk markers for CVD.

Detailed description

Elevated serum cholesterol is a major contributor to cardiovascular disease (CVD), which is responsible for \~1/3 of all deaths in the US. However, about 50% of those who experience heart attacks have normal cholesterol levels. Cholesterol is carried in lipoproteins (HDL, LDL, and VLDL) and the amount in circulation is used to evaluate CVD risk. However, the particle size and density of lipoprotein subfractions may be more predictive for atherogenesis than their total levels. Dietary fatty acids are well recognized modulators of lipoproteins, and ultimately CVD risk. Saturated and trans fatty acids have a negative effect on CVD risk while poly- and monounsaturated fatty acids (PUFA, MUFA) appear to be protective. The Mediterranean Diet (Med Diet) decreases atherogenic lipoproteins and reduces systemic inflammation. It is unknown how high cholesterol intake within a Med Diet will affect these parameters, although recent evidence implies that the fatty acid content of the diet is more important than the cholesterol content. Therefore, this project will evaluate the daily inclusion of whole eggs, a high cholesterol food, in the Med Diet on lipid profiles, lipoprotein particle size and density and biomarkers of systemic inflammation.

Conditions

Interventions

TypeNameDescription
OTHERControl Diet4-week intake of Control Diet 5 day rotating menu
OTHERMed Diet4-week intake of Med Diet 5 day rotating menu
OTHERMed Diet + Whole Egg4-week intake of Med Diet plus Whole Egg 5 day rotating menu

Timeline

Start date
2016-04-01
Primary completion
2020-03-25
Completion
2020-03-25
First posted
2016-04-13
Last updated
2022-08-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02737293. Inclusion in this directory is not an endorsement.