Assessment of Optimal Egg Intake in a Healthy Population

NCT02531958 | Completed

• 1 other identifier: H15-227
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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

  14 Weeks

Secondary Outcomes (1)

• Plasma trimethylamine oxide (TMAO)

  14 Weeks

Study Arms (3)

1 Egg

EXPERIMENTAL

Consumption of 1 egg per day for 4 weeks

Other: Eggs

2 Eggs

EXPERIMENTAL

Consumption of 2 eggs per day for 4 weeks

Other: Eggs

3 Eggs

EXPERIMENTAL

Consumption of 3 eggs per day for 4 weeks

Other: Eggs

Interventions

Eggs OTHER

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

1 Egg; 2 Eggs; 3 Eggs

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Related Publications (1)

• 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.

  PMID: 28077734 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Eggs

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Maria Luz Fernandez, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 25, 2015
• Study Start: August 14, 2015
• Primary Completion: December 18, 2015
• Study Completion: May 31, 2017
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

US (1)