Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern in Hyperlipidemic Adults (NCT05807334) | Clinical Trial Compass
UnknownNot Applicable
Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern in Hyperlipidemic Adults
United States45 participantsStarted 2023-03-07
Plain-language summary
This randomized, cross-over design, controlled trial will assess the effects of 8 weeks of daily inclusion of 2 whole eggs in the Dietary Approaches to Stop Hypertension (DASH) eating plan, compared with their exclusion, on cardio-metabolic risk markers and diet quality in hyperlipidemic adults.
Who can participate
Age range
18 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
. Men \>18 years of age
. Post-menopausal women not currently on hormone replacement therapy
. Total cholesterol of 240-300 mg/dl and /or LDL cholesterol of 130-190 mg/dl, and/or a total cholesterol to HDL ratio of \>5.7
Exclusion criteria
. Failure to meet inclusion criteria
. Anticipated inability to complete study protocol for any reason
. Allergy to eggs
. Current eating disorder
. Restricted diets by choice that do not permit ingestion of eggs (e.g., vegan)
. Unstable use of lipid-lowering or antihypertensive medications (i.e., change in dose during the three months prior to enrollment) and/or unwilling to refrain from taking medication for 12 hours prior to endothelial function scanning
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
1
Endothelial function, % flow-mediated dilatation
Timeframe: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
2
Serum LDL cholesterol, mg/dL
Timeframe: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
. Use of insulin, glucose-sensitizing medication, or vasoactive medication (including glucocorticoids, antineoplastic agents, some psychoactive agents, or bronchodilators)
. Unstable use of antidepressant medications (i.e., change in dose during the three months prior to enrollment)