Benefits of Eggs in Combination With a Plant-based Diet

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Coronary Artery Disease, Diabetes, Metabolic Syndrome

Intervention / Treatment
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* Other: Consume 2 eggs with spinach per day
* Other: Egg Subsitute with spinach per day


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized Crossover design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Egg intake<br>Consumption of 2 eggs with spinach daily for breakfast for 4 weeks | Other: Consume 2 eggs with spinach per day<br>* 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<br>* Other names: Egg substitute;|
| Experimental: Egg Subsitute<br>Consumption of 2 egg substitutes daily for breakfast for 4 weeks | Other: Egg Subsitute with spinach per day<br>* Egg Subsitute with spinach per day<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eggs, lutein, zeaxanthin, choline, metabolic syndrome, plant-based diet