Benefits of Eggs in Combination With a Plant-based Diet

Evaluation of the Role of Eggs on Antioxidant Status, Plasma Choline and Lipoprotein Metabolism in Adults With Metabolic Syndrome Consuming a Plant-based Diet

The main objective of the study is to demonstrate that the inclusion of eggs to a plant-based diet will not increase the risk for heart disease but will increase the concentration of lutein and zeaxanthin, two important antioxidants and will also increase choline, an important component of membrane phospholipids.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Diabetes; Metabolic Syndrome
• Intervention / Treatment: Other: Consume 2 eggs with spinach per day; Other: Egg Subsitute with spinach per day

Detailed Description

Results from studies involving cells, animal models and clinical trials have demonstrated that lutein and zeaxanthin potentially protect against chronic diseases, including age-related macular degeneration, cataracts, coronary heart disease and stroke. Plasma concentrations of lutein and zeaxanthin are closely associated with their antioxidant properties and with their protection against reactive oxygen species (ROS).

Choline is recognized as an essential nutrient for health because of its many functions in growth and development, as well as neurological function and formation of membrane phospholipids, including phosphatidylcholine (PC) and sphingomyelin.

Therefore the objective of this study is to demonstrate that inclusion of eggs in a plant-based diet will potentiate the benefits of this healthy diet by increasing plasma concentrations of lutein, zexanthin and choline presents in egg yolks and theoretically increase the antioxidant and anti-inflammatory actions of these components. This would be potentially more important in those individuals with metabolic syndrome, which is the target population of this intervention.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • Department of Nutritional Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All genders
• 35-70 years
• Metabolic syndrome (based on 3 out of 5 characteristics: waist circumference. 88 cm for women and > 102 cm for men; plasma triglycerides > 150 mg/dL, blood pressure > 135/85 mm Hg, fasting glucose > 100 mg/dL and HDL < 40 mg/dL for men and < 50 mg/dL for women)
• Willing to consume a spinach omelet made with 2 eggs or the equivalent amount of egg substitute daily for 4 weeks each
• Willing to follow a plant-based diet for 13 weeks
• Not have cardiovascular disease, high cholesterol, diabetes, cancer, liver or renal disease
• Proficient in English

Exclusion Criteria:

• Self-reported diabetes, cardiovascular disease, history of stroke, liver disease or cancer
• Taking glucose lowering medications
• Triglycerides > 500 mg/dL
• Cholesterol > 240 mg/dL
• Blood pressure > 145/100 mm Hg
• Allergic to eggs or spinach

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Egg intake; Consumption of 2 eggs with spinach daily for breakfast for 4 weeks	Other: Consume 2 eggs with spinach per day; Participants will be randomly allocated to consume either 2 eggs or 2 egg substitutes with spinach daily for 4 weeks and after a 3-week wash out, they will be allocated to the alternate treatment; Other Names: Egg substitute
Experimental: Egg Subsitute; Consumption of 2 egg substitutes daily for breakfast for 4 weeks	Other: Egg Subsitute with spinach per day; Egg Subsitute with spinach per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma lutein	Plasma lutien will be measured by HPLC. The units are expresses as µmol/L	1 year
Plasma choline	It will be measured by mass spectometry. The units are expressed as nmol/mL	1 year
Plasma Zeaxanthin	Plasma zeaxanthin will by measured by HPLC. The units are expressed as µmol/L	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma lipids	Total, LDL and HDL cholesterol and triglycerides will be measured by an automated spectrometer simultaneously. The units are expressed as mg/dL	1 year
Plasma glucose	Plasma glucose will be measured by an automated spectrometer. Units are expressed as mg/dL	1 Year

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: American Egg Board
• Investigators: Principal Investigator: Maria-Luz Fernandez, PhD, University of Connecticut

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: lutein; metabolic syndrome; eggs; choline; zeaxanthin; plant-based diet
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Insulin Resistance; Hyperinsulinism; Coronary Disease; Coronary Artery Disease; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: H19-178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No