Assessment of Optimal Egg Intake in a Healthy Population

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Other: Eggs

• Registration Number: NCT02531958
• Lead Sponsor: University of Connecticut

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-08-14
• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-21
• Study First Posted: 2015-08-25
• Primary Completion: 2015-12-18
• Study Completion: 2017-05-31
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1 Egg	Eggs	Consumption of 1 egg per day for 4 weeks
2 Eggs	Eggs	Consumption of 2 eggs per day for 4 weeks
3 Eggs	Eggs	Consumption of 3 eggs per day for 4 weeks

Primary Outcome Measures

Name	Time	Method
Plasma high-density lipoprotein (HDL)	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 Outcome Measures

Name	Time	Method
Plasma trimethylamine oxide (TMAO)	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

Trial Locations

Locations (1)

University of Connecticut; 🇺🇸 Storrs, Connecticut, United States