Whole Egg Intake and the Mediterranean Diet

NCT02737293 | Terminated

• 1 other identifier: GFHNRC147
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in lipoprotein metabolism

  Assess lipid metabolism response to the intervention.

  baseline and 4 weeks

Secondary Outcomes (1)

• Change in inflammatory markers

  baseline and 4 weeks

Study Arms (3)

Control Diet

EXPERIMENTAL

Menu based on the average American diet.

Other: Control Diet

Med Diet

EXPERIMENTAL

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

Other: Med Diet

Med Diet + Whole Egg

EXPERIMENTAL

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

Interventions

Control Diet OTHER

4-week intake of Control Diet 5 day rotating menu

Control Diet

Med Diet OTHER

4-week intake of Med Diet 5 day rotating menu

Med Diet

Med Diet + Whole Egg OTHER

4-week intake of Med Diet plus Whole Egg 5 day rotating menu

Med Diet + Whole Egg

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA Grand Forks Human Nutrition Research Center: lead
• Egg Nutrition Center: collaborator

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

Related Links

• Grand Forks Human Nutrition Research Center Current Nutrition Studies

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Picklo, PhD

  USDA Grand Forks Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 13, 2016
• Study Start: April 1, 2016
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)