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Whole Egg Intake and the Mediterranean Diet

Whole Egg Intake and the Mediterranean Diet

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02737293
Enrollment
33
Registered
2016-04-13
Start date
2016-04-30
Completion date
2020-03-25
Last updated
2022-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Brief 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.

Interventions

OTHERControl Diet

4-week intake of Control Diet 5 day rotating menu

4-week intake of Med Diet 5 day rotating menu

OTHERMed Diet + Whole Egg

4-week intake of Med Diet plus Whole Egg 5 day rotating menu

Sponsors

Egg Nutrition Center
CollaboratorOTHER
USDA Grand Forks Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Willingness to comply with the demands of the experimental protocol * Not performing vigorous exercise \>2 times per week * BMI 25-39.9 kg/m2 * Non-nicotine-using

Exclusion criteria

* Have an egg allergy * Have diabetes * Have high triglyceride levels * Have uncontrolled high blood pressure * Have used tobacco products or nicotine in any form including snuff, pills and patches, or e-cigarettes in the previous 6 months * Use prescription medications or over-the-counter lipid lowering drugs (such as statins) or anti-inflammatory medications (such as aspirin, ibuprofen or Aleve) on a regular basis * Take omega 3 supplements, plant sterols or sterol esters * Are pregnant or lactating * Have been diagnosed with an eating disorder * Inability to give consent * Unwillingness or inability to consume the treatment diets

Design outcomes

Primary

MeasureTime frameDescription
Change in lipoprotein metabolismbaseline and 4 weeksAssess lipid metabolism response to the intervention.

Secondary

MeasureTime frameDescription
Change in inflammatory markersbaseline and 4 weeksDetermine inflammatory marker response to the intervention.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026