Benefits of Eggs in Combination With a Plant-based Diet

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04234334
• Other study ID #: H19-178
• Status: Completed
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2022
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Diabetes
• Metabolic Syndrome
• Syndrome

Intervention

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
• Egg Subsitute with spinach per day
Egg Subsitute with spinach per day

Locations

Country	Name	City	State
United States	Department of Nutritional Sciences	Storrs	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	American Egg Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma lutein	Plasma lutien will be measured by HPLC. The units are expresses as µmol/L	1 year
Primary	Plasma choline	It will be measured by mass spectometry. The units are expressed as nmol/mL	1 year
Primary	Plasma Zeaxanthin	Plasma zeaxanthin will by measured by HPLC. The units are expressed as µmol/L	1 year
Secondary	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
Secondary	Plasma glucose	Plasma glucose will be measured by an automated spectrometer. Units are expressed as mg/dL	1 Year