Whole Egg Intake and the Mediterranean Diet

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Overweight
• Intervention / Treatment: Other: Control Diet; Other: Med Diet; Other: Med Diet + Whole Egg

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Grand Forks, North Dakota, United States, 58203
      • USDA Grand Forks Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control Diet; Menu based on the average American diet.	Other: Control Diet; 4-week intake of Control Diet 5 day rotating menu
Experimental: Med Diet; Menu based on the typical Mediterranean diet (Med Diet) pattern.	Other: Med Diet; 4-week intake of Med Diet 5 day rotating menu
Experimental: Med Diet + Whole Egg; Menu based on the typical Mediterranean diet (Med Diet) pattern with the addition of 1 whole egg per 1000 kilocalories.	Other: Med Diet + Whole Egg; 4-week intake of Med Diet plus Whole Egg 5 day rotating menu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lipoprotein metabolism	Assess lipid metabolism response to the intervention.	baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inflammatory markers	Determine inflammatory marker response to the intervention.	baseline and 4 weeks

Collaborators and Investigators

• Sponsor: USDA Grand Forks Human Nutrition Research Center
• Collaborators: Egg Nutrition Center
• Investigators: Principal Investigator: Matthew Picklo, PhD, USDA Grand Forks Human Nutrition Research Center

Publications and helpful links

Helpful Links

• Grand Forks Human Nutrition Research Center Current Nutrition Studies

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): March 25, 2020
• Study Completion (Actual): March 25, 2020

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: GFHNRC147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No