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Whole Egg Intake and the Mediterranean Diet

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

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.

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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

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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737293


Contacts
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Contact: Matthew Picklo, PhD 701-795-8380 matthew.picklo@usda.gov
Contact: Bret Rust, PhD 701-795-8139 bret.rust@usda.gov

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

Additional Information:
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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    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms