Benefits of Eggs in Combination With a Plant-based Diet

Sponsor

University of Connecticut (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04234334

Collaborator

American Egg Board (Other)

Enrollment

Location

Arms

31.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Diabetes Metabolic Syndrome	Other: Consume 2 eggs with spinach per day Other: Egg Subsitute with spinach per day	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized Crossover designRandomized Crossover design

Masking:

Single (Participant)

Masking Description:

Egg or Egg substitutes (whites only) will be provided to subjects and since they are similar in appearance and color, they will not know when they are consuming them

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jan 13, 2020

Actual Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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