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Assessment of Optimal Egg Intake in a Healthy Population

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Connecticut
ClinicalTrials.gov Identifier:
NCT02531958
First received: August 20, 2015
Last updated: December 29, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention
Cardiovascular Disease
Other: Eggs

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessment of Optimal Egg Intake in a Healthy Population

Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • Plasma high-density lipoprotein (HDL) [ Time Frame: 14 Weeks ]
    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


Secondary Outcome Measures:
  • Plasma trimethylamine oxide (TMAO) [ Time Frame: 14 Weeks ]
    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


Estimated Enrollment: 40
Study Start Date: August 2015
Estimated Study Completion Date: May 2017
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Egg
Consumption of 1 egg 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.
Experimental: 2 Eggs
Consumption of 2 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.
Experimental: 3 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.

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

Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02531958

Locations
United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269
Sponsors and Collaborators
University of Connecticut
Investigators
Principal Investigator: Maria Luz Fernandez, PhD University of Connecticut
  More Information

Responsible Party: University of Connecticut
ClinicalTrials.gov Identifier: NCT02531958     History of Changes
Other Study ID Numbers: H15-227
Study First Received: August 20, 2015
Last Updated: December 29, 2016

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on March 22, 2017