Assessment of Optimal Egg Intake in a Healthy Population

Cardiovascular Disease Clinical Trial

Official title:

Assessment of Optimal Egg Intake in a Healthy Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531958
• Other study ID #: H15-227
• Status: Completed
• Phase: N/A
• First received: August 20, 2015
• Last updated: June 23, 2017
• Start date: August 14, 2015
• Est. completion date: May 31, 2017

Study information

• Verified date: June 2017
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 31, 2017
• Est. primary completion date: December 18, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma high-density lipoprotein (HDL)	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	14 Weeks
Secondary	Plasma trimethylamine oxide (TMAO)	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	14 Weeks