Whole Egg Intake and the Mediterranean Diet

• Sponsor: USDA Grand Forks Human Nutrition Research Center (U.S. Fed)
• Overall Status: Terminated
• CT.gov ID: NCT02737293
• Collaborator: Egg Nutrition Center (Other)
• Enrollment: 33
• Location: 1
• Arms: 3
• Actual Duration (Months): 47.8
• Patients Per Site Per Month: 0.7

Study Details

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	N/A

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
• Actual Enrollment: 33 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: Apr 1, 2016
• Actual Primary Completion Date: Mar 25, 2020
• Actual Study Completion Date: Mar 25, 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 [baseline and 4 weeks]

   Assess lipid metabolism response to the intervention.

Secondary Outcome Measures

1. Change in inflammatory markers [baseline and 4 weeks]

   Determine inflammatory marker response to the intervention.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	USDA Grand Forks Human Nutrition Research Center	Grand Forks	North Dakota	United States	58203

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

Study Documents (Full-Text)

• Informed Consent Form - Aug 7, 2020

More Information

Additional Information:

• Grand Forks Human Nutrition Research Center Current Nutrition Studies

Publications

None provided.

• Responsible Party: USDA Grand Forks Human Nutrition Research Center
• ClinicalTrials.gov Identifier: NCT02737293
• Other Study ID Numbers: GFHNRC147
• First Posted: Apr 13, 2016
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Aug 4, 2022