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Completed

NCT Number: NCT04234334

Benefits of Eggs in Combination With a Plant-based Diet

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutritional Sciences

Storrs, Connecticut, 06269, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Consume 2 eggs with spinach per day

Other

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

Egg Subsitute with spinach per day

Other

Egg Subsitute with spinach per day

Primary outcomes

  1. Plasma lutein

    Time frame: 1 year

    Plasma lutien will be measured by HPLC. The units are expresses as µmol/L

  2. Plasma choline

    Time frame: 1 year

    It will be measured by mass spectometry. The units are expressed as nmol/mL

  3. Plasma Zeaxanthin

    Time frame: 1 year

    Plasma zeaxanthin will by measured by HPLC. The units are expressed as µmol/L

Secondary outcomes

  1. Plasma lipids

    Time frame: 1 year

    Total, LDL and HDL cholesterol and triglycerides will be measured by an automated spectrometer simultaneously. The units are expressed as mg/dL

  2. Plasma glucose

    Time frame: 1 Year

    Plasma glucose will be measured by an automated spectrometer. Units are expressed as mg/dL

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • American Egg Board

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 21, 2020
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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