Clinical trial NCT04234334: Benefits of Eggs in Combination With a Plant-based Diet
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Diabetes
Metabolic Syndrome
Keywords: eggs
lutein
zeaxanthin
choline
metabolic syndrome
plant-based diet
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2020-01-21
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized Crossover design
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma lutein
timeFrame: 1 year
measure: Plasma choline
timeFrame: 1 year
measure: Plasma Zeaxanthin
timeFrame: 1 year
Secondary outcomes:
measure: Plasma lipids
timeFrame: 1 year
measure: Plasma glucose
timeFrame: 1 Year
Other outcomes:
Locations:
city: Storrs
country: United States
facility: Department of Nutritional Sciences
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Maria-Luz Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References: