An interventional study of Eggs in Cardiovascular Disease, sponsored by University of Connecticut. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-27.
Sponsored by University of Connecticut · Not applicable, Interventional, and Prevention
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.
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.
4,905 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 38 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
Consumption of 1 egg per day for 4 weeks
Other: Eggs
Consumption of 2 eggs per day for 4 weeks
Other: Eggs
Consumption of 3 eggs per day for 4 weeks
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.
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
Time frame: 14 Weeks
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
Time frame: 14 Weeks
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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University of Connecticut