Assessment of Optimal Egg Intake in a Healthy Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-14

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1 Egg

Consumption of 1 egg per day for 4 weeks

Group Type EXPERIMENTAL

Eggs

Intervention Type OTHER

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

2 Eggs

Consumption of 2 eggs per day for 4 weeks

Group Type EXPERIMENTAL

Eggs

Intervention Type OTHER

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

3 Eggs

Consumption of 3 eggs per day for 4 weeks

Group Type EXPERIMENTAL

Eggs

Intervention Type OTHER

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

Interventions

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Eggs

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes