Whole Egg Intake and the Mediterranean Diet

USDA Grand Forks Human Nutrition Research Center

Status: Terminated

Conditions: Overweight; Obesity

Treatments: Other: Control Diet; Other: Med Diet; Other: Med Diet + Whole Egg

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02737293

GFHNRC147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

Control Diet

Experimental group

Description:

Menu based on the average American diet.

Treatment:

Other: Control Diet

Med Diet

Experimental group

Description:

Menu based on the typical Mediterranean diet (Med Diet) pattern.

Treatment:

Other: Med Diet

Med Diet + Whole Egg

Experimental group

Description:

Menu based on the typical Mediterranean diet (Med Diet) pattern with the addition of 1 whole egg per 1000 kilocalories.

Treatment:

Other: Med Diet + Whole Egg