Assessment of Optimal Egg Intake in a Healthy Population

Recently, the United States Department of Agriculture (USDA) has recommended removal of the 300mg/day limit on dietary cholesterol intake due to a lack of evidence supporting a connection between cholesterol intake and increased risk for cardiovascular disease (CVD). Previous work has shown that daily intake of eggs actually favorably alters many parameters associated with CVD risk. Conversely, emerging research suggests that choline, a nutrient in eggs, may be converted into trimethylamine oxide (TMAO) by the intestinal microbiota. TMAO is thought to increase the risk for CVD. Therefore, the purpose of this study is to determine a threshold of daily egg intake at which the risk for CVD is not negatively impacted in a young, healthy population.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut

Storrs, Connecticut, 06269, United States

About this study

The purpose of this study is to establish a threshold of egg intake at which CVD risk is not negatively altered in young, healthy individuals. Participants (age 18-30, healthy lipid profile) will undergo a 2-week washout period followed by daily intake of 1, 2, and 3 eggs per day for 4 weeks each. Blood samples will be collected at baseline and following each 4-week dietary period. Samples will be analyzed to determine the impact of daily intake of increasing numbers of eggs on blood lipids, TMAO, biomarkers of oxidative stress and inflammation, and expression of cholesterol-related genes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

BMI 18.5-29.9 kg/m2
Proficient in English
Cholesterol ≤ 240 mg/dL
Willing to consume 1, 2, and 3 eggs per day for 4 weeks each

Exclusion criteria

Diabetes mellitus, cardiovascular disease, history of stroke, renal disease, liver disease, cancer, or eating disorder
Taking glucose-lowering supplements or medications
Taking triglyceride-lowering medications, bile acid sequestrants, or high-dose chromium or cinnamon supplements
Plasma glucose < 126 mg/dL, triglycerides > 500 mg/dL, or blood pressure > 140/90 mmHg (average of 3 readings)
Allergy to eggs

Treatment and study plan

Eggs

Other

Participants will complete a 2-week washout period followed by intake of 1, 2, and 3 eggs per day for 4 weeks each.

Primary outcomes

Plasma high-density lipoprotein (HDL)

Time frame: 14 Weeks

Plasma HDL (in mg/dL) will be measured at 2, 6, 10, and 14 weeks to determine the impact of daily egg intake on HDL

Secondary outcomes

Plasma trimethylamine oxide (TMAO)

Time frame: 14 Weeks

Plasma levels of TMAO (in µm) will be measured at weeks 2, 6, 10, and 14 to determine the extent to which daily egg intake impacts plasma TMAO concentrations

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2017
First posted: Aug 25, 2015
Registry last updated: Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed