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Whole Egg Intake and the Mediterranean Diet

Primary Purpose

Overweight, Obesity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control Diet
Med Diet
Med Diet + Whole Egg
Sponsored by
USDA Grand Forks Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • USDA Grand Forks Human Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control Diet

Med Diet

Med Diet + Whole Egg

Arm Description

Menu based on the average American diet.

Menu based on the typical Mediterranean diet (Med Diet) pattern.

Menu based on the typical Mediterranean diet (Med Diet) pattern with the addition of 1 whole egg per 1000 kilocalories.

Outcomes

Primary Outcome Measures

Change in lipoprotein metabolism
Assess lipid metabolism response to the intervention.

Secondary Outcome Measures

Change in inflammatory markers
Determine inflammatory marker response to the intervention.

Full Information

First Posted
March 31, 2016
Last Updated
August 1, 2022
Sponsor
USDA Grand Forks Human Nutrition Research Center
Collaborators
Egg Nutrition Center
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1. Study Identification

Unique Protocol Identification Number
NCT02737293
Brief Title
Whole Egg Intake and the Mediterranean Diet
Official Title
Whole Egg Intake and the Mediterranean Diet
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID-19 and expiration of grant funds
Study Start Date
April 2016 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center
Collaborators
Egg Nutrition Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Diet
Arm Type
Experimental
Arm Description
Menu based on the average American diet.
Arm Title
Med Diet
Arm Type
Experimental
Arm Description
Menu based on the typical Mediterranean diet (Med Diet) pattern.
Arm Title
Med Diet + Whole Egg
Arm Type
Experimental
Arm Description
Menu based on the typical Mediterranean diet (Med Diet) pattern with the addition of 1 whole egg per 1000 kilocalories.
Intervention Type
Other
Intervention Name(s)
Control Diet
Intervention Description
4-week intake of Control Diet 5 day rotating menu
Intervention Type
Other
Intervention Name(s)
Med Diet
Intervention Description
4-week intake of Med Diet 5 day rotating menu
Intervention Type
Other
Intervention Name(s)
Med Diet + Whole Egg
Intervention Description
4-week intake of Med Diet plus Whole Egg 5 day rotating menu
Primary Outcome Measure Information:
Title
Change in lipoprotein metabolism
Description
Assess lipid metabolism response to the intervention.
Time Frame
baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change in inflammatory markers
Description
Determine inflammatory marker response to the intervention.
Time Frame
baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Picklo, PhD
Organizational Affiliation
USDA Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/
Description
Grand Forks Human Nutrition Research Center Current Nutrition Studies

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Whole Egg Intake and the Mediterranean Diet

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