Whole Egg Intake and the Mediterranean Diet

Obesity Clinical Trial

Official title:

Whole Egg Intake and the Mediterranean Diet

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02737293
• Other study ID #: GFHNRC147
• Status: Terminated
• Phase: N/A
• Start date: April 2016
• Est. completion date: March 25, 2020

Study information

• Verified date: August 2022
• Source: USDA Grand Forks Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• Control Diet
4-week intake of Control Diet 5 day rotating menu
• Med Diet
4-week intake of Med Diet 5 day rotating menu
• Med Diet + Whole Egg
4-week intake of Med Diet plus Whole Egg 5 day rotating menu

Locations

Country	Name	City	State
United States	USDA Grand Forks Human Nutrition Research Center	Grand Forks	North Dakota

Sponsors (2)

Lead Sponsor	Collaborator
USDA Grand Forks Human Nutrition Research Center	Egg Nutrition Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lipoprotein metabolism	Assess lipid metabolism response to the intervention.	baseline and 4 weeks
Secondary	Change in inflammatory markers	Determine inflammatory marker response to the intervention.	baseline and 4 weeks

External Links

•   Grand Forks Human Nutrition Research Center Current Nutrition Studies