CompletedNot Applicable

Benefits of Eggs in Combination With a Plant-based Diet

United States24 participantsStarted 2020-01-13

Plain-language 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.

Who can participate

Age range

35 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plasma lutein

Timeframe: 1 year

Plasma choline

Timeframe: 1 year

Plasma Zeaxanthin

Timeframe: 1 year

Trial details

NCT IDNCT04234334

SponsorUniversity of Connecticut

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-31

View on ClinicalTrials.gov More Coronary Artery Disease trials

Plain-language summary

Who can participate

Age range

35 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.