Clinical trial NCT02531958: Assessment of Optimal Egg Intake in a Healthy Population
Official title: Assessment of Optimal Egg Intake in a Healthy Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2015-08-25
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma high-density lipoprotein (HDL)
timeFrame: 14 Weeks
Secondary outcomes:
measure: Plasma trimethylamine oxide (TMAO)
timeFrame: 14 Weeks
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Maria Luz Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DiMarco DM, Norris GH, Millar CL, Blesso CN, Fernandez ML. Intake of up to 3 Eggs per Day Is Associated with Changes in HDL Function and Increased Plasma Antioxidants in Healthy, Young Adults. J Nutr. 2017 Mar;147(3):323-329. doi: 10.3945/jn.116.241877. Epub 2017 Jan 11.