Clinical trial NCT02737293: Whole Egg Intake and the Mediterranean Diet
Official title: Whole Egg Intake and the Mediterranean Diet
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: Egg Nutrition Center
First posted: 2016-04-13
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in lipoprotein metabolism
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Change in inflammatory markers
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Matthew Picklo, PhD
role: PRINCIPAL_INVESTIGATOR
References: