Evaluation of the Role of Eggs on Antioxidant Status, Plasma Choline and Lipoprotein Metabolism in Adults With Metabolic Syndrome Consuming a Plant-based Diet
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Connecticut
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Plasma lutein
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- 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
Eligibility Criteria
- Ages
- 35 Years to 70 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Egg intake
Consumption of 2 eggs with spinach daily for breakfast for 4 weeks
Intervention: Consume 2 eggs with spinach per day (Other)
Egg Subsitute
Consumption of 2 egg substitutes daily for breakfast for 4 weeks
Intervention: Egg Subsitute with spinach per day (Other)
Outcomes
Primary Outcomes
Plasma lutein
Time Frame: 1 year
Plasma lutien will be measured by HPLC. The units are expresses as µmol/L
Plasma choline
Time Frame: 1 year
It will be measured by mass spectometry. The units are expressed as nmol/mL
Plasma Zeaxanthin
Time Frame: 1 year
Plasma zeaxanthin will by measured by HPLC. The units are expressed as µmol/L
Secondary Outcomes
- Plasma lipids(1 year)
- Plasma glucose(1 Year)
Investigators
Maria Luz Fernandez
Professor
University of Connecticut