Eggs for Heart Health

Overseen By Stacey Meily

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Penn State University

Must not be taking: Antihypertensives, Lipid-lowering, Glucose-lowering, others

Disqualifiers: Diabetes, Cardiovascular event, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of eating eggs on heart health. Participants will follow a healthy diet, with some consuming two eggs daily and others three eggs weekly. The researchers aim to assess how these diets affect heart health indicators after four weeks. The trial seeks individuals who haven't experienced a major change in body weight recently and consume fewer than 14 eggs per week. Participants should not have had a heart attack or follow a vegetarian or vegan diet. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to important heart health research.

Will I have to stop taking my current medications?

If you are taking anti-hypertensive, lipid-lowering, or glucose-lowering medications, you cannot participate in this trial. If you take supplements that affect heart health and are unwilling to stop during the study, you also cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that eating eggs is generally safe for most people. Some studies indicate that consuming more eggs does not increase heart disease risk for most individuals. However, other studies suggest that eating more than half an egg daily might slightly raise this risk. Conversely, some research found that eating eggs could lower both good and bad cholesterol levels. Overall, the evidence is mixed, but eggs are often considered safe when eaten in moderation as part of a balanced diet. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for heart health that often rely on medications or supplements, this approach uses whole eggs as a dietary intervention. Researchers are excited about this because eggs are a natural source of essential nutrients like proteins, vitamins, and healthy fats, which may improve heart health in a more holistic way. The study compares a diet with a moderate intake of eggs to a diet with a higher intake, exploring whether increased egg consumption can offer additional heart benefits. This approach could provide a more accessible and enjoyable way for people to maintain heart health compared to more restrictive or synthetic options.

What evidence suggests that this trial's treatments could be effective for heart health?

This trial will compare the effects of different egg consumption levels on heart health. Research has shown mixed results regarding the impact of egg consumption on heart health. Some studies suggest that eating more eggs might increase the risk of heart disease and stroke. However, other research has found no strong link between egg consumption and heart problems. Interestingly, one study found that regular egg consumption might even reduce the risk of dying from heart issues in healthy older adults. Overall, the connection between eggs and heart health is complex and may depend on individual health factors. ^{2 3 6 7 8}

Who Is on the Research Team?

Kristina Petersen

Principal Investigator

The Pennsylvania State University

Are You a Good Fit for This Trial?

This trial is for adults with a BMI of 25-35, eating less than 14 eggs per week, stable weight in the last 6 months, and certain levels of cholesterol, blood sugar, and blood pressure. It's not for those outside these health ranges.

Inclusion Criteria

Blood pressure <140/90 mmHg

My weight has been stable, changing less than 10% in the last 6 months.

Intake of <14 eggs/week for the prior 3 months

Exclusion Criteria

Participation in another clinical trial within 30 days of baseline

I haven't had cancer recurrence in over 10 years, or non-melanoma skin cancer in over 5 years.

Food allergies/intolerance/sensitives/dislikes of foods included in the study menu

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants follow a healthy diet containing 2 eggs per day for 4 weeks

4 weeks

Regular monitoring visits

Washout

Participants undergo a washout period to clear any effects of the first diet

2-4 weeks

Treatment Period 2

Participants follow a healthy diet containing 3 eggs per week for 4 weeks

4 weeks

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Whole Egg

Trial Overview The study tests heart health effects from eating a healthy diet with either 2 eggs daily or just 3 eggs weekly over a period of four weeks.

How Is the Trial Designed?

Group I: Healthy Diet + Eggs (HD+E) Experimental Treatment 1 Intervention

2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal

Group II: Healthy Diet (HD) Active Control 1 Intervention

2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD)

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

American Egg Board

Collaborator

Trials

30

Recruited

62,100+

Published Research Related to This Trial

In a study of 32 adults with coronary artery disease, daily consumption of eggs for 6 weeks showed no negative impact on cardiac risk factors such as endothelial function, cholesterol levels, blood pressure, or body weight.

The results suggest that including eggs in the diet does not pose additional risks for heart health in individuals already diagnosed with coronary artery disease, challenging previous dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of egg ingestion on endothelial function in adults with coronary artery disease: a randomized, controlled, crossover trial. Katz, DL., Gnanaraj, J., Treu, JA., et al.[2014]

Recent cohort studies indicate that consuming one egg a day does not increase cardiovascular risk for most people, despite past concerns about dietary cholesterol.

Intervention studies suggest that egg consumption is safe and may even improve lipid profiles in both healthy individuals and those with cardiometabolic diseases, although caution is advised for diabetic patients regarding high egg intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Egg intake and cardiovascular disease: a scientifi c literature review Dussaillant, C., Echeverría, G., Rozowski, J., et al.[2018]

In a 14-week study with 38 healthy young adults, increasing egg intake to 3 eggs per day led to beneficial changes in cardiovascular disease (CVD) risk biomarkers, including increased HDL cholesterol and decreased LDL cholesterol levels.

Despite the increase in egg consumption, there were no adverse changes in plasma TMAO levels or LDL cholesterol, suggesting that eating up to 3 eggs a day can be safe and beneficial for heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intake of up to 3 Eggs/Day Increases HDL Cholesterol and Plasma Choline While Plasma Trimethylamine-N-oxide is Unchanged in a Healthy Population. DiMarco, DM., Missimer, A., Murillo, AG., et al.[2021]

In a study of 9,263 Japanese adults followed for 14 years, higher egg consumption was associated with lower total cholesterol levels in women, suggesting a potential link between egg intake and cholesterol management.

Women who consumed 1-2 eggs per week had significantly lower all-cause mortality compared to those who ate one egg per day, indicating that moderate egg consumption may be beneficial for health, particularly in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Egg consumption, serum cholesterol, and cause-specific and all-cause mortality: the National Integrated Project for Prospective Observation of Non-communicable Disease and Its Trends in the Aged, 1980 (NIPPON DATA80). Nakamura, Y., Okamura, T., Tamaki, S., et al.[2023]

Research indicates that egg consumption does not universally increase the risk of coronary heart disease, as 70% of people (hyporesponders) show little to no change in plasma cholesterol levels after eating eggs.

Eggs can promote the formation of larger, less harmful LDL particles and increase beneficial antioxidants like lutein and zeaxanthin, suggesting that they may have protective effects, especially for eye health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary cholesterol provided by eggs and plasma lipoproteins in healthy populations. Fernandez, ML.[2019]

A review of 17 studies involving 556 subjects found that increasing dietary cholesterol by 100 mg per day raises the ratio of total to HDL cholesterol, which can negatively impact cholesterol profiles.

The results suggest that limiting dietary cholesterol, such as from egg consumption, may still be advisable to maintain a healthier cholesterol balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary cholesterol from eggs increases the ratio of total cholesterol to high-density lipoprotein cholesterol in humans: a meta-analysis. Weggemans, RM., Zock, PL., Katan, MB.[2022]

Consuming more than 4 whole eggs per week does not significantly impact cardiovascular disease (CVD) risk factors compared to consuming 4 or fewer eggs, indicating that whole egg intake may be safe for middle-aged and older adults.

In contrast, eating more than 4 whole eggs per week leads to higher levels of total cholesterol, HDL, and LDL compared to equivalent amounts of egg substitutes, suggesting that egg substitutes may be a better option for lowering CVD risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of whole egg intake on blood pressure, lipids and lipoproteins in middle-aged and older population: A systematic review and meta-analysis of randomized controlled trials. Wang, MX., Wong, CH., Kim, JE.[2020]

In a study of 23,524 U.S. adults, egg consumption was not linked to total or coronary heart disease (CHD) mortality, suggesting that eating eggs may not increase the risk of these outcomes.

Interestingly, higher egg intake was associated with a 66% lower risk of stroke mortality in males, while also being linked to increased risks of type 2 diabetes and hypertension, indicating a complex relationship between egg consumption and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Egg Consumption and Risk of Total and Cause-Specific Mortality: An Individual-Based Cohort Study and Pooling Prospective Studies on Behalf of the Lipid and Blood Pressure Meta-analysis Collaboration (LBPMC) Group. Mazidi, M., Katsiki, N., Mikhailidis, DP., et al.[2020]

In a 26-week double-blind study involving military personnel with high cholesterol, those who consumed a drink containing hyperimmune egg protein showed no significant increase in total cholesterol levels, while control and placebo groups did.

The hyperimmune egg drink also helped maintain stable levels of important lipoproteins, suggesting it may help reduce the risk of cardiovascular diseases by positively influencing serum lipoprotein regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study on the effect of hyperimmune egg protein on elevated cholesterol levels and cardiovascular risk factors. Karge, WH., Deluca, JP., Marchitelli, LJ., et al.[2009]

A systematic review of 24 studies involving nearly 12 million participants found that consuming one additional egg per day is associated with a 6% increased risk of all-cause mortality, particularly in women and Americans with adjusted hyperlipidemia.

Egg consumption was linked to a higher risk of cardiovascular disease (CVD) mortality in individuals over 60 years old, but no significant associations were found for ischemic heart disease or stroke mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Egg Consumption with Risk of All-Cause and Cardiovascular Disease Mortality: A Systematic Review and Dose-Response Meta-Analysis of Observational Studies. Ma, W., Zhang, Y., Pan, L., et al.[2023]

In a study of 37,121 US adults over a median follow-up of 7.8 years, no significant link was found between egg consumption and overall or heart disease mortality, suggesting that eating eggs may not negatively impact health outcomes.

The relationship between dietary cholesterol intake and all-cause mortality varied based on baseline intake levels: lower cholesterol intake (<250 mg/day) was associated with reduced mortality risk, while higher intake (≥250 mg/day) was linked to increased mortality risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Intakes of Eggs and Cholesterol in Relation to All-Cause and Heart Disease Mortality: A Prospective Cohort Study. Xia, PF., Pan, XF., Chen, C., et al.[2021]

A meta-analysis of 7 studies found that consuming up to one egg daily is associated with a 12% decreased risk of stroke, suggesting that moderate egg intake may be beneficial for stroke prevention.

The same analysis showed no significant association between egg consumption and the risk of coronary heart disease (CHD), indicating that eating eggs does not increase the risk of heart problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of Egg Consumption and Risk of Coronary Heart Disease and Stroke. Alexander, DD., Miller, PE., Vargas, AJ., et al.[2020]

Citations

1. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2728487

Dietary Cholesterol or Egg Consumption With Incident ... Among US adults, higher consumption of dietary cholesterol or eggs was significantly associated with higher risk of incident CVD and all-cause mortality in a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10285014/

Eggs and Cardiovascular Disease Risk: An Update ... The other study found an increased risk of 7% for total stroke and 25% for hemorrhagic stroke with 20 g egg/day continuous intake (total: 95% CI ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.119.015743

Dietary Intakes of Eggs and Cholesterol in Relation to All‐ ... In this study we did not find a significant association between dietary intake of eggs and all‐cause and heart disease mortality in US adults, ...

4. nature.com nature.com/articles/s41598-025-19028-0

Dietary cholesterol intake and egg consumption in relation ... For all-cause death outcomes, the participant survival rate was significantly lowered in the group consuming > 1 egg/day compared with the group ...

5. monash.edu monash.edu/medicine/news/latest/2025-articles/regularly-eating-eggs-supports-a-lower-risk-of-cardiovascular-disease-related-death

Regularly eating eggs supports a lower risk of ... Regular consumption of eggs is associated with a 29 per cent lower risk of cardiovascular disease-related death in relatively healthy older adults.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10200385/

The effect of egg consumption on cardiometabolic health ... Recent evidence-based reviews conclude that increased egg consumption is not associated with CVD risk in the general population.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10688106/

Egg consumption and risk of cardiovascular disease In another study of six cohorts, the findings showed an 8% increased risk of coronary heart disease with each additional consumption of half an ...

8. acc.org acc.org/About-ACC/Press-Releases/2024/03/28/11/43/eggs-may-not-be-bad-for-your-heart-after-all

Eggs May Not Be Bad for Your Heart After All Results showed a -0.64 mg/dL and a -3.14 mg/dL reduction in HDL-cholesterol (“good” cholesterol) and LDL cholesterol (“bad” cholesterol), ...