Overview

This trial is active, not recruiting.

Condition cardiovascular disease
Treatment eggs
Sponsor University of Connecticut
Start date August 2015
End date December 2015
Trial size 40 participants
Trial identifier NCT02531958, H15-227

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Consumption of 1 egg per day for 4 weeks
eggs
Participants will complete a 2-week washout period followed by intake of 1, 2, and 3 eggs per day for 4 weeks each.
(Experimental)
Consumption of 2 eggs per day for 4 weeks
eggs
Participants will complete a 2-week washout period followed by intake of 1, 2, and 3 eggs per day for 4 weeks each.
(Experimental)
Consumption of 3 eggs per day for 4 weeks
eggs
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

Measure
Plasma high-density lipoprotein (HDL)
time frame: 14 Weeks

Secondary Outcomes

Measure
Plasma trimethylamine oxide (TMAO)
time frame: 14 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 30 years old.

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

Additional Information

Official title Assessment of Optimal Egg Intake in a Healthy Population
Principal investigator Maria Luz Fernandez, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Connecticut.