Whole Egg Intake and the Mediterranean Diet

• ClinicalTrials.gov Identifier: NCT02737293
• Recruitment Status: Recruiting
• First Posted: April 13, 2016
• Last Update Posted: September 17, 2019
• Sponsor: USDA Grand Forks Human Nutrition Research Center
• Collaborator: Egg Nutrition Center
• Information provided by (Responsible Party): Matthew Picklo, USDA Grand Forks Human Nutrition Research Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Overweight; Obesity	Other: Control Diet; Other: Med Diet; Other: Med Diet + Whole Egg	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Whole Egg Intake and the Mediterranean Diet
• Actual Study Start Date: April 2016
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in lipoprotein metabolism [ Time Frame: baseline and 4 weeks ]
   Assess lipid metabolism response to the intervention.

Secondary Outcome Measures :

1. Change in inflammatory markers [ Time Frame: baseline and 4 weeks ]
   Determine inflammatory marker response to the intervention.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Matthew Picklo, PhD; 701-795-8380; matthew.picklo@usda.gov

Contact: Bret Rust, PhD; 701-795-8139; bret.rust@usda.gov

Locations

United States, North Dakota

USDA Grand Forks Human Nutrition Research Center; Recruiting

Grand Forks, North Dakota, United States, 58203

Contact: Angela J Scheett, MPH, RD 701-795-8386 angela.scheett@usda.gov

Sponsors and Collaborators

USDA Grand Forks Human Nutrition Research Center

Egg Nutrition Center

Investigators

• Principal Investigator: Matthew Picklo, PhD; USDA Grand Forks Human Nutrition Research Center

More Information

Additional Information:

Grand Forks Human Nutrition Research Center Current Nutrition Studies 

• Responsible Party: Matthew Picklo, PhD, USDA Grand Forks Human Nutrition Research Center
• ClinicalTrials.gov Identifier: NCT02737293 History of Changes
• Other Study ID Numbers: GFHNRC147
• First Posted: April 13, 2016
• Last Update Posted: September 17, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Overweight; Body Weight; Signs and Symptoms